Trial Outcomes & Findings for Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC (NCT NCT02805660)
NCT ID: NCT02805660
Last Updated: 2021-04-06
Results Overview
Toxicities were graded using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03. Any of the following events considered to be causally related to treatment with mocetinostat in combination with durvalumab that occurred during Phase 1 were considered a DLT: * Any Grade 4 immune-related adverse event (irAE) * Grade 3 or greater colitis * Grade 3 or greater noninfectious pneumonitis * Grade 2 pneumonitis that did not resolve to ≤ Grade 1 within 3 days of the initiation of maximal supportive care * Grade 3 irAE (excluding colitis or pneumonitis) that: * Did not resolve to Grade 2 within 3 days after onset of the event despite optimal medical management including systemic corticosteroids, or * Did not resolve to Grade ≤1 or Baseline within 14 days * Liver transaminase elevation \>8×upper limit of normal (ULN) or total bilirubin \>5×ULN * Grade 3 or greater non-irAE, except nausea, vomiting, anorexia, dehydration, or diarrhea
TERMINATED
PHASE1/PHASE2
83 participants
28 days
2021-04-06
Participant Flow
Participant milestones
| Measure |
Phase 1: Dose Escalation - 50 mg
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 70 mg
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 90 mg
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 2: Combination Regimen - Cohort 1
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70mg).
|
Phase 2: Combination Regimen - Cohort 2
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 3
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 4
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
11
|
18
|
3
|
23
|
19
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
11
|
18
|
3
|
23
|
19
|
Reasons for withdrawal
| Measure |
Phase 1: Dose Escalation - 50 mg
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 70 mg
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 90 mg
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 2: Combination Regimen - Cohort 1
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70mg).
|
Phase 2: Combination Regimen - Cohort 2
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 3
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 4
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
5
|
2
|
9
|
5
|
0
|
14
|
12
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
3
|
1
|
0
|
2
|
|
Overall Study
Study terminated by Sponsor
|
0
|
0
|
1
|
4
|
2
|
3
|
1
|
|
Overall Study
Miscellaneous
|
0
|
1
|
0
|
4
|
0
|
6
|
4
|
Baseline Characteristics
Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC
Baseline characteristics by cohort
| Measure |
Phase 1: Dose Escalation - 50 mg
n=5 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 70 mg
n=4 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 90 mg
n=11 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 2: Combination Regimen - Cohort 1
n=18 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 2
n=3 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 3
n=23 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 4
n=19 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
33 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
50 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
42 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
41 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
7 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
76 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
16 Participants
n=115 Participants
|
67 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
11 participants
n=5 Participants
|
18 participants
n=4 Participants
|
3 participants
n=21 Participants
|
23 participants
n=10 Participants
|
19 participants
n=115 Participants
|
83 participants
n=24 Participants
|
|
Smoking History
Non-smoker
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
21 Participants
n=24 Participants
|
|
Smoking History
Current Smoker
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
10 Participants
n=24 Participants
|
|
Smoking History
Former Smoker
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
52 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: DLT Evaluable Population - Participant must have either been on study for one full cycle and have received treatment with durvalumab and at least 9 of 12 scheduled mocetinostat doses (75%) in Cycle 1 or have experienced a DLT in Cycle 1.
Toxicities were graded using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) version 4.03. Any of the following events considered to be causally related to treatment with mocetinostat in combination with durvalumab that occurred during Phase 1 were considered a DLT: * Any Grade 4 immune-related adverse event (irAE) * Grade 3 or greater colitis * Grade 3 or greater noninfectious pneumonitis * Grade 2 pneumonitis that did not resolve to ≤ Grade 1 within 3 days of the initiation of maximal supportive care * Grade 3 irAE (excluding colitis or pneumonitis) that: * Did not resolve to Grade 2 within 3 days after onset of the event despite optimal medical management including systemic corticosteroids, or * Did not resolve to Grade ≤1 or Baseline within 14 days * Liver transaminase elevation \>8×upper limit of normal (ULN) or total bilirubin \>5×ULN * Grade 3 or greater non-irAE, except nausea, vomiting, anorexia, dehydration, or diarrhea
Outcome measures
| Measure |
Phase 1: Dose Escalation - 50 mg
n=4 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 70 mg
n=3 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 90 mg
n=6 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 2: Combination Regimen - Cohort 1
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 2
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 3
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 4
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) During the First 28-day Cycle of Combination Treatment In Phase 1
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to approximately 10 monthsPopulation: Clinical Activity Evaluable Population - The Clinical Activity Evaluable Population was defined as all participants who had at least one on-study disease assessment or discontinued from treatment for progressive disease (PD).
Objective Response Rate (ORR) was defined as the number of participants documented to have a confirmed Complete Response (CR) or Partial Response (PR). Complete Response was defined as the complete disappearance of all target lesions with the exception of nodal disease. Partial Response was defined at least a 30% decrease in the sum of diameters of target measurable lesions. Responses were determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Participants without response data were counted as non-responders. Inferential statistical analyses were conducted for Phase 2 only, as efficacy was not part of the Phase 1 objectives.
Outcome measures
| Measure |
Phase 1: Dose Escalation - 50 mg
n=5 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 70 mg
n=4 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 90 mg
n=9 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 2: Combination Regimen - Cohort 1
n=15 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 2
n=3 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 3
n=21 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 4
n=13 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
0 Percentage of participants
Interval 0.0 to 52.2
|
0 Percentage of participants
Interval 0.0 to 60.2
|
0 Percentage of participants
Interval 0.0 to 33.6
|
6.7 Percentage of participants
Interval 0.2 to 31.9
|
0 Percentage of participants
Interval 0.0 to 70.8
|
9.5 Percentage of participants
Interval 1.2 to 30.4
|
23.1 Percentage of participants
Interval 5.0 to 53.8
|
SECONDARY outcome
Timeframe: Day 1 to 28 days after last dose of study treatment (up to a maximum of 125 weeks in phase 1 and a maximum of 92 weeks in phase 2)Population: Safety Population - The Safety population was defined as all participants who received at least 1 dose of either mocetinostat or durvalumab.
Outcome measures
| Measure |
Phase 1: Dose Escalation - 50 mg
n=5 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 70 mg
n=4 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 90 mg
n=11 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 2: Combination Regimen - Cohort 1
n=18 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 2
n=3 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 3
n=23 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 4
n=19 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events
|
5 Participants
|
4 Participants
|
10 Participants
|
18 Participants
|
3 Participants
|
23 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 10 monthsPopulation: Clinical Activity Evaluable Population (Subgroup of Responders) - Duration of response was only calculated for the subgroup of participants achieving a CR or PR.
DR was defined as the time in days from date of the first documentation of objective response (Complete Response \[CR\] or Partial Response \[PR\]) to the first documentation of objective Progressive Disease (PD) or to death due to any cause in the absence of documented PD. DR was only calculated for the subgroup of participants who achieved a Best Overall Response of CR or PR and was presented for responses assessed by Investigator's assessment. Data is displayed for Phase 2 only, as no participants experienced an objective response (CR or PR) during Phase 1.
Outcome measures
| Measure |
Phase 1: Dose Escalation - 50 mg
n=1 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 70 mg
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 90 mg
n=2 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 2: Combination Regimen - Cohort 1
n=3 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 2
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 3
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 4
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
|---|---|---|---|---|---|---|---|
|
Duration of Response (DR)
|
115 Days
Due to a small number of participants and events, data was not estimable.
|
—
|
329 Days
Due to a small number of participants and events, data was not estimable.
|
NA Days
Interval 230.0 to
Due to a small number of participants and events, data was not estimable.
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 10 monthsPopulation: Clinical Activity Evaluable Population - The Clinical Activity Evaluable Population was defined as all participants who had at least one on-study disease assessment or discontinued from treatment for progressive disease (PD).
Clinical benefit rate (CBR) was defined as the number of participants documented to have a confirmed Complete Response (CR), Partial Response (PR), or Stable Disease (SD) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Participants who were not be able to be assessed for response were counted as non-responders.
Outcome measures
| Measure |
Phase 1: Dose Escalation - 50 mg
n=5 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 70 mg
n=4 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 90 mg
n=9 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 2: Combination Regimen - Cohort 1
n=15 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 2
n=3 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 3
n=21 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 4
n=13 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
|---|---|---|---|---|---|---|---|
|
Clinical Benefit Rate (CBR)
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Randomization until progressive disease or death due to any cause (up to 42 months)Population: Modified Intent-to-Treat Population (mITT) - The mITT Population was defined as all participants who received treatment with both mocetinostat and durvalumab on this study.
Progression-free survival (PFS) was defined as the time from date of first study treatment to first Progressive Disease (PD) or death due to any cause in the absence of documented PD per RECIST v1.1
Outcome measures
| Measure |
Phase 1: Dose Escalation - 50 mg
n=5 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 70 mg
n=4 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 90 mg
n=9 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 2: Combination Regimen - Cohort 1
n=18 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 2
n=3 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 3
n=23 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 4
n=14 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
|---|---|---|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
3 Months
Interval 1.88 to
Due to a small number of participants and events, data was not estimable.
|
NA Months
Due to a small number of participants and events, data was not estimable.
|
2 Months
Interval 1.51 to 27.57
|
3 Months
Interval 2.01 to 5.86
|
4 Months
Due to a small number of participants and events, data was not estimable.
|
2 Months
Interval 1.94 to 14.57
|
3 Months
Interval 2.04 to 9.57
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Modified Intent-to-Treat Population (mITT) - The mITT Population was defined as all participants who received treatment with both mocetinostat and durvalumab on this study.
Outcome measures
| Measure |
Phase 1: Dose Escalation - 50 mg
n=5 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 70 mg
n=4 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 90 mg
n=9 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 2: Combination Regimen - Cohort 1
n=18 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 2
n=3 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 3
n=23 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 4
n=14 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
|---|---|---|---|---|---|---|---|
|
1-Year Survival Rate
|
0.40 Proportion of participants
Interval 0.05 to 0.75
|
0.38 Proportion of participants
Interval 0.01 to 0.81
|
0.53 Proportion of participants
Interval 0.18 to 0.8
|
0.72 Proportion of participants
Interval 0.41 to 0.89
|
1.00 Proportion of participants
Interval 1.0 to 1.0
|
0.52 Proportion of participants
Interval 0.31 to 0.7
|
0.50 Proportion of participants
Interval 0.23 to 0.72
|
SECONDARY outcome
Timeframe: From date of first study treatment until death due to any cause (up to 42 months)Population: Modified Intent-to-Treat Population (mITT) - The mITT Population was defined as all participants who received treatment with both mocetinostat and durvalumab on this study.
OS was defined as the time from first dose of study treatment to the date of death due to any cause.
Outcome measures
| Measure |
Phase 1: Dose Escalation - 50 mg
n=5 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 70 mg
n=4 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 90 mg
n=9 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 2: Combination Regimen - Cohort 1
n=18 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 2
n=3 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 3
n=23 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 4
n=14 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
7 Months
Interval 2.4 to 32.99
|
11 Months
Interval 7.17 to
Due to a small number of participants and events, data was not estimable.
|
16 Months
Interval 3.49 to 26.05
|
NA Months
Interval 7.37 to
Due to a small number of participants and events, data was not estimable.
|
NA Months
Due to a small number of participants and events, data was not estimable.
|
15 Months
Interval 7.73 to
Due to a small number of participants and events, data was not estimable.
|
14 Months
Interval 5.07 to 20.86
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre-dose, 1, 3, and 7 hours post-dose, Cycle 1 Day 15 pre-dose and 1 hour post-dose, Cycle 2 Day 1 pre-dose and 1 hour post-dose, Cycle 3 Day 1 pre-dose and 1 hour post-dose and Cycle 7 Day 1 pre-dose (each cycle is 28 days)Population: Pharmacokinetic Evaluable Population - The Pharmacokinetic (PK) Evaluable Population was defined as all patients who had PK concentration data collected for mocetinostat or durvalumab. Participants were combined for analysis of mocetinistat concentrations, as prespecified in the analysis shells, based on the actual dose of mocetinistat received in each phase of the study. Pharmacokinetic measures at 3 and 7 hours post dose on Cycle 1 Day 1 were only planned for Phase 1.
Outcome measures
| Measure |
Phase 1: Dose Escalation - 50 mg
n=9 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 70 mg
n=7 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 90 mg
n=11 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 2: Combination Regimen - Cohort 1
n=1 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 2
n=63 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 3
n=6 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 4
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
|---|---|---|---|---|---|---|---|
|
Concentration of Mocetinistat in Blood Plasma
Cycle 1: Day 1 - pre-dose
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean and corresponding coefficient of variation could not be estimated as none of the participants had an evaluable result (i.e. above LOQ).
|
0.91 ng/mL
Geometric Coefficient of Variation 83.20
|
1.02 ng/mL
Geometric Coefficient of Variation 114.68
|
—
|
39.65 ng/mL
Geometric Coefficient of Variation 175.97
|
—
|
—
|
|
Concentration of Mocetinistat in Blood Plasma
Cycle 1: Day 15 - 1 hour post-dose
|
102.67 ng/mL
Geometric Coefficient of Variation 7.17
|
22.30 ng/mL
Geometric Coefficient of Variation 14646.88
|
18.32 ng/mL
Geometric Coefficient of Variation 1297.79
|
—
|
10.86 ng/mL
Geometric Coefficient of Variation 330.59
|
—
|
—
|
|
Concentration of Mocetinistat in Blood Plasma
Cycle 3: Day 1 - pre-dose
|
0.89 ng/mL
Geometric Coefficient of Variation 44.73
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean and corresponding coefficient of variation could not be estimated as none of the participants had an evaluable result (i.e. above LOQ).
|
—
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean and corresponding coefficient of variation could not be estimated as none of the participants had an evaluable result (i.e. above LOQ).
|
4.08 ng/mL
Geometric Coefficient of Variation 238.84
|
0.92 ng/mL
Geometric Coefficient of Variation 40.65
|
—
|
|
Concentration of Mocetinistat in Blood Plasma
Cycle 3: Day 1 - 1 hour post-dose
|
22.73 ng/mL
Geometric Coefficient of Variation 301.01
|
92.40 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).
|
—
|
0.73 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).
|
14.39 ng/mL
Geometric Coefficient of Variation 319.34
|
25.12 ng/mL
Geometric Coefficient of Variation 378.13
|
—
|
|
Concentration of Mocetinistat in Blood Plasma
Cycle 1: Day 1 - 1 hour post-dose
|
19.85 ng/mL
Geometric Coefficient of Variation 441.16
|
106.61 ng/mL
Geometric Coefficient of Variation 43.77
|
92.56 ng/mL
Geometric Coefficient of Variation 143.96
|
—
|
12.19 ng/mL
Geometric Coefficient of Variation 289.89
|
—
|
—
|
|
Concentration of Mocetinistat in Blood Plasma
Cycle 1: Day 1 - 3 hours post-dose
|
33.53 ng/mL
Geometric Coefficient of Variation 111.21
|
61.63 ng/mL
Geometric Coefficient of Variation 24.78
|
55.27 ng/mL
Geometric Coefficient of Variation 53.19
|
—
|
—
|
—
|
—
|
|
Concentration of Mocetinistat in Blood Plasma
Cycle 1: Day 1 - 7 hours post-dose
|
15.75 ng/mL
Geometric Coefficient of Variation 58.30
|
20.92 ng/mL
Geometric Coefficient of Variation 27.20
|
33.89 ng/mL
Geometric Coefficient of Variation 45.21
|
—
|
—
|
—
|
—
|
|
Concentration of Mocetinistat in Blood Plasma
Cycle 1: Day 15 - pre-dose
|
5.36 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).
|
0.98 ng/mL
Geometric Coefficient of Variation 95.06
|
3.84 ng/mL
Geometric Coefficient of Variation 202.26
|
—
|
1.92 ng/mL
Geometric Coefficient of Variation 127.96
|
—
|
—
|
|
Concentration of Mocetinistat in Blood Plasma
Cycle 2: Day 1 - pre-dose
|
0.72 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).
|
0.85 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).
|
1.22 ng/mL
Geometric Coefficient of Variation 83.65
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean and corresponding coefficient of variation could not be estimated as none of the participants had an evaluable result (i.e. above LOQ).
|
1.16 ng/mL
Geometric Coefficient of Variation 91.63
|
0.68 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).
|
—
|
|
Concentration of Mocetinistat in Blood Plasma
Cycle 2: Day 1 - 1 hour post-dose
|
75.11 ng/mL
Geometric Coefficient of Variation 25.53
|
49.30 ng/mL
Geometric Coefficient of Variation 86.19
|
2.45 ng/mL
Geometric Coefficient of Variation 83.60
|
0.72 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).
|
14.65 ng/mL
Geometric Coefficient of Variation 396.22
|
105.00 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).
|
—
|
|
Concentration of Mocetinistat in Blood Plasma
Cycle 7: Day 1 - pre-dose
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean and corresponding coefficient of variation could not be estimated as none of the participants had an evaluable result (i.e. above LOQ).
|
0.85 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).
|
1.35 ng/mL
Geometric Coefficient of Variation NA
Geometric coefficient of variation could not be estimated as only one participant had an evaluable result (i.e. above LOQ).
|
—
|
0.65 ng/mL
Geometric Coefficient of Variation 35.19
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean and corresponding coefficient of variation could not be estimated as none of the participants had an evaluable result (i.e. above LOQ).
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 pre-dose + end of infusion, Cycle 1 Day 15 pre-mocetinostat dose, Cycle 2 Day 1 pre-dose, Cycle 3 Day 1 pre-dose, Cycle 4 Day 1 pre-dose + end of infusion, Cycle 7 Day 1 pre-dose + 90 days after participant's last dose (Up to max 133 weeks)Population: Pharmacokinetic Evaluable Population - The Pharmacokinetic (PK) Evaluable Population was defined as all patients who had PK concentration data collected for mocetinostat or durvalumab. Participants were combined for analysis of mocetinistat concentrations, as prespecified in the analysis shells, based on the actual dose of mocetinistat received in each phase of the study. Pharmacokinetic measures at 3 and 7 hours post dose on Cycle 1 Day 1 were only planned for Phase 1.
Plasma concentration of Durvalumab was evaluated. All participants received the same Durvalumab dose regardless of Mocetinistat dose group.
Outcome measures
| Measure |
Phase 1: Dose Escalation - 50 mg
n=76 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 70 mg
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 90 mg
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 2: Combination Regimen - Cohort 1
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 2
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 3
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 4
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
|---|---|---|---|---|---|---|---|
|
Concentration of Durvalumab in Blood Plasma
90 days after last dose
|
12304.13 ng/mL
Geometric Coefficient of Variation 501.74
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration of Durvalumab in Blood Plasma
Cycle 1: Day 1 - pre-dose
|
259.18 ng/mL
Geometric Coefficient of Variation 334.86
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration of Durvalumab in Blood Plasma
Cycle 1: Day 1 - end of infusion
|
385779.56 ng/mL
Geometric Coefficient of Variation 36.49
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration of Durvalumab in Blood Plasma
Cycle 1: Day 15 - pre-Mocetinostat
|
102925.55 ng/mL
Geometric Coefficient of Variation 40.05
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration of Durvalumab in Blood Plasma
Cycle 2: Day 1 - pre-dose
|
44140.86 ng/mL
Geometric Coefficient of Variation 130.83
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration of Durvalumab in Blood Plasma
Cycle 3: Day 1 - pre-dose
|
72049.14 ng/mL
Geometric Coefficient of Variation 91.22
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration of Durvalumab in Blood Plasma
Cycle 4: Day 1 - pre-dose
|
101852.34 ng/mL
Geometric Coefficient of Variation 89.01
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration of Durvalumab in Blood Plasma
Cycle 4: Day 1 - end of infusion
|
365307.01 ng/mL
Geometric Coefficient of Variation 81.59
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Concentration of Durvalumab in Blood Plasma
Cycle 7: Day 1 - pre-dose
|
130335.14 ng/mL
Geometric Coefficient of Variation 70.34
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 10 monthsPopulation: ADA Evaluable Population - The ADA Evaluable Population was defined as all patients who received at least 1 dose of either durvalumab or mocetinostat for whom ADA results were available.
Outcome measures
| Measure |
Phase 1: Dose Escalation - 50 mg
n=1 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 70 mg
n=4 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 90 mg
n=9 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 2: Combination Regimen - Cohort 1
n=17 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 2
n=3 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 3
n=22 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 4
n=15 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With the Presence of Anti-Drug Antibody (ADA) in the Blood
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Modified Intent-to-Treat Population (mITT) - The mITT Population was defined as all participants who received treatment with both mocetinostat and durvalumab on this study.
Outcome measures
| Measure |
Phase 1: Dose Escalation - 50 mg
n=5 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 50 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 70 mg
n=4 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 70 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 90 mg
n=9 Participants
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
Mocetinostat - 90 mg: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 2: Combination Regimen - Cohort 1
n=18 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 2
n=3 Participants
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 3
n=23 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 4
n=14 Participants
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Tumor Expression of Programmed Cell Death Ligand 1 (PD-L1) at Baseline
No/Low PD-L1 Expression
|
0 Participants
|
0 Participants
|
0 Participants
|
17 Participants
|
0 Participants
|
6 Participants
|
9 Participants
|
|
Number of Participants With Tumor Expression of Programmed Cell Death Ligand 1 (PD-L1) at Baseline
High PD-L1 Expression
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants With Tumor Expression of Programmed Cell Death Ligand 1 (PD-L1) at Baseline
Missing
|
5 Participants
|
4 Participants
|
8 Participants
|
1 Participants
|
0 Participants
|
9 Participants
|
4 Participants
|
Adverse Events
Phase 1: Dose Escalation - 50 mg
Phase 1: Dose Escalation - 70 mg
Phase 1: Dose Escalation - 90 mg
Phase 2: Combination Regimen - Cohort 1
Phase 2: Combination Regimen - Cohort 2
Phase 2: Combination Regimen - Cohort 3
Phase 2: Combination Regimen - Cohort 4
Serious adverse events
| Measure |
Phase 1: Dose Escalation - 50 mg
n=5 participants at risk
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this phase.
Mocetinostat: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 70 mg
n=4 participants at risk
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this phase.
Mocetinostat: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 90 mg
n=11 participants at risk
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this phase.
Mocetinostat: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 2: Combination Regimen - Cohort 1
n=18 participants at risk
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 2
n=3 participants at risk
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 3
n=23 participants at risk
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 4
n=19 participants at risk
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Cardiac disorders
Pericarditis
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Axillary pain
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Pneumonia
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
8.7%
2/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
21.1%
4/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Septic shock
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Psychiatric disorders
Delirium
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
Other adverse events
| Measure |
Phase 1: Dose Escalation - 50 mg
n=5 participants at risk
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this phase.
Mocetinostat: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 70 mg
n=4 participants at risk
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this phase.
Mocetinostat: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 1: Dose Escalation - 90 mg
n=11 participants at risk
The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this phase.
Mocetinostat: Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
|
Phase 2: Combination Regimen - Cohort 1
n=18 participants at risk
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 2
n=3 participants at risk
Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 3
n=23 participants at risk
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
Phase 2: Combination Regimen - Cohort 4
n=19 participants at risk
Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.
Durvalumab - 1500 mg: Participants received durvalumab as an intravenous infusion every 4 weeks.
Mocetinostat - Recommended Phase 2 Dose (70 mg): Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Gastrointestinal wall thickening
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
8.7%
2/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
27.3%
3/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
16.7%
3/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
15.8%
3/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Blood and lymphatic system disorders
Neutropenia
|
40.0%
2/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
27.3%
3/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
8.7%
2/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
15.8%
3/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
8.7%
2/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Cardiac disorders
Palpitations
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Ear and labyrinth disorders
Hyperacusis
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Endocrine disorders
Hypothyroidism
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Eye disorders
Vision blurred
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Eye disorders
Dry eye
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Eye disorders
Episcleritis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Eye disorders
Eye swelling
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Eye disorders
Visual impairment
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Nausea
|
80.0%
4/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
50.0%
2/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
81.8%
9/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
38.9%
7/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
100.0%
3/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
43.5%
10/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
26.3%
5/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
2/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
75.0%
3/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
36.4%
4/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
50.0%
9/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
47.8%
11/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
47.4%
9/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Vomiting
|
80.0%
4/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
72.7%
8/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
22.2%
4/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
26.1%
6/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
26.3%
5/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Constipation
|
40.0%
2/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
16.7%
3/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
26.1%
6/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
40.0%
2/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
13.0%
3/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
40.0%
2/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Ascites
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Dry mouth
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Abdominal distension
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Anorectal disorder
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Oesophageal dilatation
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Fatigue
|
80.0%
4/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
50.0%
2/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
63.6%
7/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
61.1%
11/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
100.0%
3/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
60.9%
14/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
42.1%
8/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Oedema peripheral
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
13.0%
3/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
15.8%
3/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
66.7%
2/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
8.7%
2/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Asthenia
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
11.1%
2/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
8.7%
2/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Pyrexia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Chills
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Chest discomfort
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Chest pain
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
15.8%
3/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Pain
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
15.8%
3/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Early satiety
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Axillary pain
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Catheter site discharge
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Facial pain
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Local swelling
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Malaise
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Nodule
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
General disorders
Peripheral swelling
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Immune system disorders
Drug hypersensitivity
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Urinary tract infection
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
22.2%
4/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
13.0%
3/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Cystitis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Bronchitis
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Sinusitis
|
40.0%
2/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Influenza
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Folliculitis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Furuncle
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Infected cyst
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Lung infection
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Infections and infestations
Nasal herpes
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
11.1%
2/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Injury, poisoning and procedural complications
Medication error
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
11.1%
2/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Injury, poisoning and procedural complications
Stoma site irritation
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Investigations
Weight decreased
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
27.3%
3/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
16.7%
3/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
13.0%
3/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Investigations
White blood cell count decreased
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Investigations
Blood alkaline phosphatase decreased
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Investigations
Blood urine present
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Investigations
Lipase increased
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Investigations
Platelet count decreased
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
60.0%
3/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
36.4%
4/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
38.9%
7/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
30.4%
7/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
26.3%
5/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Dehydration
|
40.0%
2/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
22.2%
4/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
13.0%
3/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
26.3%
5/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
54.5%
6/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
11.1%
2/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
13.0%
3/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
17.4%
4/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
27.3%
3/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
27.3%
3/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
8.7%
2/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
8.7%
2/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Metabolism and nutrition disorders
Malnutrition
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
22.2%
4/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
8.7%
2/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
21.1%
4/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
11.1%
2/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
66.7%
2/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
13.0%
3/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
17.4%
4/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
16.7%
3/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
8.7%
2/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
40.0%
2/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
11.1%
2/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
17.4%
4/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Headache
|
40.0%
2/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
8.7%
2/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Hypoaesthesia
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
8.7%
2/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Paraesthesia
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Seizure
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Syncope
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Migraine
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Sciatica
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Nervous system disorders
Tremor
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Product Issues
Device occlusion
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
8.7%
2/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Psychiatric disorders
Depression
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Psychiatric disorders
Agitation
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
27.3%
3/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
8.7%
2/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Reproductive system and breast disorders
Pelvic pain
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
2/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
6/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
17.4%
4/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
21.1%
4/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
40.0%
2/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
27.3%
3/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
22.2%
4/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
17.4%
4/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
15.8%
3/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Skin and subcutaneous tissue disorders
Skin depigmentation
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
11.1%
2/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
16.7%
3/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
10.5%
2/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
15.8%
3/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
8.7%
2/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
11.1%
2/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Skin and subcutaneous tissue disorders
Umbilical erythema
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
4.3%
1/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
18.2%
2/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
16.7%
3/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
15.8%
3/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
25.0%
1/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.3%
1/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Vascular disorders
Orthostatic hypotension
|
20.0%
1/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
9.1%
1/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Vascular disorders
Hot flush
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
33.3%
1/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/5 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/4 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/11 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
5.6%
1/18 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/3 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/23 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
0.00%
0/19 • Adverse events (AEs) are reported from the first day of study treatment until at least 28 days after last dose of study drug, and until resolution or stabilization of acute AEs (up to 125 weeks in Phase 1 and 92 weeks in Phase 2.) Serious adverse events (SAEs) are reported from the time of informed consent until 90 days after the last administration of mocetinostat or durvalumab (up to 133 weeks in Phase 1 and 101 weeks in Phase 2.)
|
Additional Information
Tavette Neskorik, Senior Director, Clinical Science
Mirati Therapeutics
Results disclosure agreements
- Principal investigator is a sponsor employee PI can not disclose, discuss, or publish study results until final manuscript has been published.
- Publication restrictions are in place
Restriction type: OTHER