Trial Outcomes & Findings for DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST) (NCT NCT04276415)
NCT ID: NCT04276415
Last Updated: 2024-02-15
Results Overview
For hematologic toxicities, a DLT is defined as: Grade (Gr) 4 neutrophil count decreased lasting \>7 days, Gr ≥3 febrile neutropenia, Gr ≥3 anemia requiring transfusion, Gr 4 anemia, Gr 4 platelet count decreased, Gr ≥3 platelet count decreased lasting \>7 days or associated with clinically significant hemorrhage and/or requiring transfusion, and Gr 4 lymphocyte count decreased lasting ≥14 days. For non-hematologic, non-hepatic major organ toxicities, a DLT is all TEAEs of Gr ≥3 except: Gr 3 fatigue lasting \<7 days, Gr 3 nausea, vomiting, diarrhea, or anorexia that has resolved to Gr ≤2 within 3 days with maximal medical management, Gr 3 isolated lab findings not associated with signs or symptoms including alkaline phosphatase increased, hyperuricemia, serum amylase increased, and lipase increased, and Gr 3 hyponatremia lasting \<72 hours developed from Gr 1 at baseline. Symptomatic Gr 4 events were considered DLTs unless there was evidence it was associated with disease progression.
TERMINATED
PHASE1
34 participants
Cycle 1 Day 1 to Day 21 (each cycle is 21 days)
2024-02-15
Participant Flow
A total of 34 participants who met all inclusion and no exclusion criteria were enrolled and received treatment at 5 clinic sites in the United States and Japan.
Dose Escalation (Part 1) was designed to establish the maximum tolerated dose and recommended dose of expansion (RDE) for DS-6157a. Dose-Expansion (Part 2) was expected to start at the RDE to further characterize the safety and tolerability, pharmacokinetics profile, and efficacy of DS-6157a; however, due to lower than anticipated efficacy in Part 1, the Sponsor decided to terminate the study prior to Dose Expansion. Efficacy analyses were limited in Part 1; no analyses in Part 2 were conducted.
Participant milestones
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
5
|
13
|
6
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
5
|
13
|
6
|
2
|
Reasons for withdrawal
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Overall Study
Clinical progression
|
1
|
1
|
0
|
0
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
3
|
2
|
0
|
|
Overall Study
Progressive disease
|
3
|
3
|
4
|
5
|
1
|
2
|
|
Overall Study
Withdrawal by patient
|
0
|
0
|
0
|
1
|
2
|
0
|
Baseline Characteristics
DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumor (GIST)
Baseline characteristics by cohort
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
n=4 Participants
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
n=4 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
n=5 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
n=13 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
n=6 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
n=2 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
Total
n=34 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=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 14.4 • n=5 Participants
|
62.3 years
STANDARD_DEVIATION 17.4 • n=7 Participants
|
60.8 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
55.8 years
STANDARD_DEVIATION 12.9 • n=21 Participants
|
53.0 years
STANDARD_DEVIATION 9.9 • n=8 Participants
|
58.3 years
STANDARD_DEVIATION 12.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native Asian
|
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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
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=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 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=8 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
4 participants
n=21 Participants
|
2 participants
n=8 Participants
|
18 participants
n=8 Participants
|
|
Region of Enrollment
Japan
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
2 participants
n=21 Participants
|
0 participants
n=8 Participants
|
16 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 Day 1 to Day 21 (each cycle is 21 days)Population: Dose-limiting toxicities were assessed in the Dose Limiting Toxicity Evaluable Set.
For hematologic toxicities, a DLT is defined as: Grade (Gr) 4 neutrophil count decreased lasting \>7 days, Gr ≥3 febrile neutropenia, Gr ≥3 anemia requiring transfusion, Gr 4 anemia, Gr 4 platelet count decreased, Gr ≥3 platelet count decreased lasting \>7 days or associated with clinically significant hemorrhage and/or requiring transfusion, and Gr 4 lymphocyte count decreased lasting ≥14 days. For non-hematologic, non-hepatic major organ toxicities, a DLT is all TEAEs of Gr ≥3 except: Gr 3 fatigue lasting \<7 days, Gr 3 nausea, vomiting, diarrhea, or anorexia that has resolved to Gr ≤2 within 3 days with maximal medical management, Gr 3 isolated lab findings not associated with signs or symptoms including alkaline phosphatase increased, hyperuricemia, serum amylase increased, and lipase increased, and Gr 3 hyponatremia lasting \<72 hours developed from Gr 1 at baseline. Symptomatic Gr 4 events were considered DLTs unless there was evidence it was associated with disease progression.
Outcome measures
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
n=4 Participants
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
n=3 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
n=5 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
n=11 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
n=6 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
n=2 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Dose-limiting Toxicities (DLT) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 days after end of treatment, up to approximately 1 year 10 months post-treatmentPopulation: Treatment-emergent adverse events (TEAEs) were assessed in the Safety Analysis Set.
Treatment-emergent AEs (TEAEs) are adverse events with an onset date during the on-treatment period. Adverse events will be graded according to NCI CTCAE Version 5.0 and coded using the current version of Medical Dictionary for Regulatory Activities (MedDRA) version 24.1.
Outcome measures
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
n=4 Participants
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
n=4 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
n=5 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
n=13 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
n=6 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
n=2 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Weight decreased
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
White blood cell count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Decreased appetite
|
3 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Any TEAE
|
4 Participants
|
4 Participants
|
5 Participants
|
13 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Anemia
|
3 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Febrile neutropenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Neutropenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Palpitations
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Sinus tachycardia
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Lacrimation increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Vitreous floaters
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Abdominal distension
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Abdominal pain
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Abdominal pain lower
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Abdominal pain upper
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Anal fissure
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Ascites
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Diarrhea
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Dyspepsia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Flatulence
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Gastritis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Gastrooesophageal reflux disease
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Intestinal perforation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Nausea
|
3 Participants
|
3 Participants
|
3 Participants
|
11 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Vomiting
|
1 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Asthenia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Chest discomfort
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Fatigue
|
3 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Malaise
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Mucosal inflammation
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Pyrexia
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Hepatic function abnormal
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Portal hypertension
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Bronchitis
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Eye infection
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Herpes zoster
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Contusion
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Alanine aminotransferase increased
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Aspartate aminotransferase increased
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Sleep apnoea syndrome
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Blood albumin decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Blood alkaline phosphatase increased
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Blood creatinine increased
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Electrocardiogram QT prolonged
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Neutrophil count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Platelet count decreased
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Protein total decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Dehydration
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Hyperglycaemia
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Hyperuricaemia
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Hypoalbuminaemia
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Hypocalcaemia
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Hypoglycaemia
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Hypokalaemia
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Arthritis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Back pain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Flank pain
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Muscle fatigue
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Muscle spasms
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Muscular weakness
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Myalgia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Disturbance in attention
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Dizziness
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Dysarthria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Dysgeusia
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Headache
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Hyperaesthesia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Peripheral sensory neuropathy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Taste disorder
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Anxiety
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Confusional state
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Delirium
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Haematuria
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Pollakiuria
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Proteinuria
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Renal disorder
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Urinary tract obstruction
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Pelvic pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Cough
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Dyspnoea
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Dyspnoea exertional
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Epistaxis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Hiccups
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Rhinorrhoea
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Hyperhidrosis
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Rash maculo-papular
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Rash papular
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Skin fissures
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Hypertension
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Hypotension
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Tachycardia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Hypothyroidism
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Eye disorder
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Constipation
|
1 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Haematemesis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Upper gastrointestinal haemorrhage
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Varices oesophageal
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Influenza like illness
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Injection site reaction
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Oedema peripheral
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Portal vein thrombosis
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
COVID-19
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Pneumonia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Upper respiratory tract infection
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Fall
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Infusion related reaction
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Procedural pain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Blood potassium decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Lymphocyte count decreased
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Hyperkalaemia
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Hyperphosphataemia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Hyponatraemia
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Hypophosphataemia
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Athralgia
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Insomnia
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Pulmonary embolism
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Alopecia
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Dry skin
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Deep vein thrombosis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Most Frequently Reported (≥10%) Any Grade Treatment-emergent Adverse Events (TEAEs) Following Intravenous Administration of DS-6157a in Patients With Advanced Gastrointestinal Stromal Tumors (GIST)
Hot flush
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 5 years post-treatmentPopulation: This outcome measure was not assessed due to early study termination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline up to 5 years post-treatmentPopulation: This outcome measure was not assessed due to early study termination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline up to 5 years post-treatmentPopulation: This outcome measure was not assessed due to early study termination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline up to 5 years post-treatmentPopulation: This outcome measure was not assessed due to early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
The plasma PK parameters were estimated using standard noncompartmental methods.
Outcome measures
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
n=4 Participants
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
n=4 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
n=5 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
n=13 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
n=6 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
n=2 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
DS-6157a: Cycle 1
|
181 day*ug/mL
Standard Deviation 18.2
|
399 day*ug/mL
Standard Deviation 178
|
574 day*ug/mL
Standard Deviation 150
|
776 day*ug/mL
Standard Deviation 346
|
1530 day*ug/mL
Standard Deviation 507
|
2140 day*ug/mL
Standard Deviation 351
|
|
Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
DS-6157a: Cycle 3
|
223 day*ug/mL
Standard Deviation 76.6
|
761 day*ug/mL
Standard Deviation 47.3
|
733 day*ug/mL
Standard Deviation 425
|
1520 day*ug/mL
Standard Deviation 654
|
2570 day*ug/mL
Standard Deviation 11.9
|
—
|
|
Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
Total anti-GPR20 antibody: Cycle 1
|
176 day*ug/mL
Standard Deviation 22.6
|
425 day*ug/mL
Standard Deviation 203
|
549 day*ug/mL
Standard Deviation 111
|
730 day*ug/mL
Standard Deviation 349
|
1530 day*ug/mL
Standard Deviation 495
|
1980 day*ug/mL
Standard Deviation 256
|
|
Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
Total anti-GPR20 antibody: Cycle 3
|
218 day*ug/mL
Standard Deviation 76.9
|
731 day*ug/mL
Standard Deviation 40.4
|
676 day*ug/mL
Standard Deviation 428
|
1570 day*ug/mL
Standard Deviation 746
|
2450 day*ug/mL
Standard Deviation 217
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
The plasma PK parameters were estimated using standard noncompartmental methods.
Outcome measures
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
n=4 Participants
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
n=4 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
n=5 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
n=13 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
n=6 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
n=2 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for MAAA-1181a Following Intravenous Administration of DS-6157a
MAAA-1181a: Cycle 1
|
6.85 day*ng/mL
Standard Deviation 2.16
|
19 day*ng/mL
Standard Deviation 2.49
|
20.5 day*ng/mL
Standard Deviation 5.53
|
51.8 day*ng/mL
Standard Deviation 23.8
|
74.8 day*ng/mL
Standard Deviation 30.2
|
111 day*ng/mL
Standard Deviation 27.9
|
|
Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve up to the Last Quantifiable Time (AUClast) for MAAA-1181a Following Intravenous Administration of DS-6157a
MAAA-1181a: Cycle 3
|
5.95 day*ng/mL
Standard Deviation 0.94
|
22.3 day*ng/mL
Standard Deviation 3.58
|
22.8 day*ng/mL
Standard Deviation 10.4
|
75.9 day*ng/mL
Standard Deviation 55.9
|
70.6 day*ng/mL
Standard Deviation 30.4
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)Population: Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set.
The plasma PK parameters were estimated using standard noncompartmental methods.
Outcome measures
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
n=4 Participants
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
n=4 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
n=5 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
n=12 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
n=6 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
n=2 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
DS-6157a: Cycle 1
|
181 day*ug/mL
Standard Deviation 18.3
|
400 day*ug/mL
Standard Deviation 157
|
512 day*ug/mL
Standard Deviation 67.1
|
821 day*ug/mL
Standard Deviation 371
|
1570 day*ug/mL
Standard Deviation 401
|
1690 day*ug/mL
Standard Deviation 499
|
|
Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
DS-6157a: Cycle 3
|
250 day*ug/mL
Standard Deviation 36.8
|
718 day*ug/mL
Standard Deviation 35.1
|
780 day*ug/mL
Standard Deviation 342
|
1430 day*ug/mL
Standard Deviation 458
|
2400 day*ug/mL
Standard Deviation 240
|
—
|
|
Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
Total anti-GPR20 antibody: Cycle 1
|
176 day*ug/mL
Standard Deviation 22.8
|
427 day*ug/mL
Standard Deviation 182
|
549 day*ug/mL
Standard Deviation 113
|
781 day*ug/mL
Standard Deviation 363
|
1570 day*ug/mL
Standard Deviation 394
|
1590 day*ug/mL
Standard Deviation 388
|
|
Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
Total anti-GPR20 antibody: Cycle 3
|
251 day*ug/mL
Standard Deviation 31.1
|
691 day*ug/mL
Standard Deviation 24.6
|
733 day*ug/mL
Standard Deviation 344
|
1460 day*ug/mL
Standard Deviation 538
|
2270 day*ug/mL
Standard Deviation 60.8
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)Population: Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set.
The plasma PK parameters were estimated using standard noncompartmental methods.
Outcome measures
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
n=4 Participants
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
n=4 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
n=5 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
n=12 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
n=5 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
n=2 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for MAAA-1181a Following Intravenous Administration of DS-6157a
MAAA-1181a: Cycle 3
|
6.48 day*ng/mL
Standard Deviation 0.52
|
21.8 day*ng/mL
Standard Deviation 3.86
|
27.6 day*ng/mL
Standard Deviation 5.07
|
70.7 day*ng/mL
Standard Deviation 61.1
|
66.9 day*ng/mL
Standard Deviation 25
|
—
|
|
Pharmacokinetic Analysis: Area Under the Plasma Concentration-time Curve in the Dosing Interval (AUCtau) for MAAA-1181a Following Intravenous Administration of DS-6157a
MAAA-1181a: Cycle 1
|
6.85 day*ng/mL
Standard Deviation 2.16
|
19.7 day*ng/mL
Standard Deviation 4.01
|
20.4 day*ng/mL
Standard Deviation 5.55
|
49.5 day*ng/mL
Standard Deviation 23.5
|
69.1 day*ng/mL
Standard Deviation 30.7
|
98.5 day*ng/mL
Standard Deviation 18.5
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
The plasma PK parameters were estimated using standard noncompartmental methods.
Outcome measures
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
n=4 Participants
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
n=4 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
n=5 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
n=13 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
n=6 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
n=2 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a
DS-6157a: Cycle 1
|
2.59 hours
Standard Deviation 1.04
|
2.09 hours
Standard Deviation 0.83
|
2.75 hours
Standard Deviation 1.53
|
2.71 hours
Standard Deviation 1.54
|
2.86 hours
Standard Deviation 2.82
|
2.7 hours
Standard Deviation 1.52
|
|
Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a
DS-6157a: Cycle 3
|
1.24 hours
Standard Deviation 0.99
|
3.75 hours
Standard Deviation 1.23
|
2.07 hours
Standard Deviation 1.65
|
2.58 hours
Standard Deviation 2.48
|
4.05 hours
Standard Deviation 4.71
|
—
|
|
Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a
Total anti-GPR20 antibody: Cycle 3
|
1.81 hours
Standard Deviation 1.02
|
4.24 hours
Standard Deviation 3.45
|
2.07 hours
Standard Deviation 1.65
|
4.96 hours
Standard Deviation 7.82
|
2.47 hours
Standard Deviation 0.12
|
—
|
|
Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a
MAAA-1181a: Cycle 1
|
10.5 hours
Standard Deviation 8.36
|
7.26 hours
Standard Deviation 2.62
|
11.1 hours
Standard Deviation 8.96
|
8.42 hours
Standard Deviation 7.16
|
34.17 hours
Standard Deviation 65.53
|
3.76 hours
Standard Deviation 0.01
|
|
Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a
Total anti-GPR20 antibody: Cycle 1
|
2.17 hours
Standard Deviation 0.96
|
3.06 hours
Standard Deviation 1.84
|
2.36 hours
Standard Deviation 0.83
|
2.53 hours
Standard Deviation 1.26
|
2.62 hours
Standard Deviation 0.99
|
1.77 hours
Standard Deviation 0.21
|
|
Pharmacokinetic Analysis: Time to Maximum Plasma Concentration (Tmax) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a
MAAA-1181a: Cycle 3
|
11.52 hours
Standard Deviation 9.85
|
18.61 hours
Standard Deviation 23.73
|
10.59 hours
Standard Deviation 8.32
|
19.63 hours
Standard Deviation 13.53
|
15.72 hours
Standard Deviation 11.79
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
The plasma PK parameters were estimated using standard noncompartmental methods.
Outcome measures
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
n=4 Participants
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
n=4 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
n=5 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
n=13 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
n=6 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
n=2 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
Total anti-GPR20 antibody: Cycle 3
|
35.2 ug/mL
Standard Deviation 2.38
|
89.9 ug/mL
Standard Deviation 15.1
|
111 ug/mL
Standard Deviation 12.4
|
160 ug/mL
Standard Deviation 42.9
|
267 ug/mL
Standard Deviation 48.1
|
—
|
|
Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
DS-6157a: Cycle 1
|
32.3 ug/mL
Standard Deviation 4.01
|
71.4 ug/mL
Standard Deviation 15.7
|
100 ug/mL
Standard Deviation 6.1
|
142 ug/mL
Standard Deviation 28.7
|
227 ug/mL
Standard Deviation 33.7
|
291 ug/mL
Standard Deviation 88.4
|
|
Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
DS-6157a: Cycle 3
|
37 ug/mL
Standard Deviation 0.55
|
90.8 ug/mL
Standard Deviation 13.8
|
118 ug/mL
Standard Deviation 16.8
|
162 ug/mL
Standard Deviation 51.9
|
280 ug/mL
Standard Deviation 47.4
|
—
|
|
Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
Total anti-GPR20 antibody: Cycle 1
|
32.3 ug/mL
Standard Deviation 1.89
|
78.8 ug/mL
Standard Deviation 23.3
|
98.6 ug/mL
Standard Deviation 7.62
|
137 ug/mL
Standard Deviation 33.7
|
237 ug/mL
Standard Deviation 26.2
|
279 ug/mL
Standard Deviation 61.5
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)Population: Pharmacokinetic parameters were assessed in the Pharmacokinetic Analysis Set.
The plasma PK parameters were estimated using standard noncompartmental methods.
Outcome measures
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
n=4 Participants
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
n=4 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
n=5 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
n=13 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
n=6 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
n=2 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for MAAA-1181a Following Intravenous Administration of DS-6157a
MAAA-1181a: Cycle 1
|
1.5 ng/mL
Standard Deviation 0.88
|
4.51 ng/mL
Standard Deviation 2.03
|
4 ng/mL
Standard Deviation 1.19
|
12.8 ng/mL
Standard Deviation 11.4
|
14.6 ng/mL
Standard Deviation 3.36
|
19.4 ng/mL
Standard Deviation 1.2
|
|
Pharmacokinetic Analysis: Maximum Plasma Concentration (Cmax) for MAAA-1181a Following Intravenous Administration of DS-6157a
MAAA-1181a: Cycle 3
|
1.12 ng/mL
Standard Deviation 0.25
|
3.48 ng/mL
Standard Deviation 1.18
|
4.78 ng/mL
Standard Deviation 1.35
|
9.76 ng/mL
Standard Deviation 5.13
|
7.92 ng/mL
Standard Deviation 1.4
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)Population: Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set.
The plasma PK parameters were estimated using standard noncompartmental methods.
Outcome measures
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
n=4 Participants
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
n=3 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
n=5 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
n=10 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
n=5 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
n=2 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
DS-6157a: Cycle 1
|
3.09 ug/mL
Standard Deviation 0.57
|
9.1 ug/mL
Standard Deviation 2.16
|
13.9 ug/mL
Standard Deviation 12.9
|
15.8 ug/mL
Standard Deviation 9.27
|
27.9 ug/mL
Standard Deviation 13.6
|
7.16 ug/mL
Standard Deviation 6
|
|
Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
DS-6157a: Cycle 3
|
5.1 ug/mL
Standard Deviation 1.87
|
14.7 ug/mL
Standard Deviation 1.68
|
21 ug/mL
Standard Deviation 8.6
|
28.6 ug/mL
Standard Deviation 7.21
|
52.8 ug/mL
Standard Deviation 12
|
—
|
|
Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
Total anti-GPR20 antibody: Cycle 1
|
3.54 ug/mL
Standard Deviation 0.84
|
8.96 ug/mL
Standard Deviation 0.36
|
8.93 ug/mL
Standard Deviation 4.9
|
14.3 ug/mL
Standard Deviation 10.1
|
24.3 ug/mL
Standard Deviation 12.6
|
6.45 ug/mL
Standard Deviation 4.82
|
|
Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for DS-6157a and Total Anti-GPR20 Antibody Following Intravenous Administration of DS-6157a
Total anti-GPR20 antibody: Cycle 3
|
6.32 ug/mL
Standard Deviation 0.87
|
11.7 ug/mL
Standard Deviation 6.05
|
23 ug/mL
Standard Deviation 9.76
|
30 ug/mL
Standard Deviation 10
|
58.8 ug/mL
Standard Deviation 13.2
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)Population: Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set.
The plasma PK parameters were estimated using standard noncompartmental methods.
Outcome measures
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
n=4 Participants
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
n=3 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
n=5 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
n=10 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
n=5 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
n=2 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for MAAA-1181a Following Intravenous Administration of DS-6157a
MAAA-1181a: Cycle 1
|
0.05 ng/mL
Standard Deviation 0.01
|
0.13 ng/mL
Standard Deviation 0.03
|
0.17 ng/mL
Standard Deviation 0.10
|
0.41 ng/mL
Standard Deviation 0.35
|
0.54 ng/mL
Standard Deviation 0.28
|
0.16 ng/mL
Standard Deviation 0.20
|
|
Pharmacokinetic Analysis: Lowest Concentration Reached After a Single Dose (Ctrough) for MAAA-1181a Following Intravenous Administration of DS-6157a
MAAA-1181a: Cycle 3
|
0.07 ng/mL
Standard Deviation 0.01
|
0.18 ng/mL
Standard Deviation 0.03
|
0.37 ng/mL
Standard Deviation 0.21
|
1.16 ng/mL
Standard Deviation 1.4
|
0.65 ng/mL
Standard Deviation 0.27
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Day 1: Predose, postdose, and 2 hours (hr), 4 hr, 7 hr postdose to Cycle 8, Day 1 predose (each cycle is 21 days)Population: Pharmacokinetic parameters were assessed in participants with available data in the Pharmacokinetic Analysis Set.
The plasma PK parameters were estimated using standard noncompartmental methods.
Outcome measures
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
n=4 Participants
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
n=4 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
n=5 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
n=12 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
n=6 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
n=2 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a
DS-6157a: Cycle 1
|
9.05 day
Standard Deviation 1.02
|
8.37 day
Standard Deviation 4.91
|
9.73 day
Standard Deviation 3.27
|
10 day
Standard Deviation 4.61
|
7.58 day
Standard Deviation 2.01
|
2.7 day
Standard Deviation 1.52
|
|
Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a
DS-6157a: Cycle 3
|
9.1 day
Standard Deviation 5.38
|
12.8 day
Standard Deviation 4
|
9.61 day
Standard Deviation 5.52
|
14.7 day
Standard Deviation 2.64
|
11.2 day
Standard Deviation 3.95
|
—
|
|
Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a
Total anti-GPR20 antibody: Cycle 1
|
9.35 day
Standard Deviation 2.08
|
8.49 day
Standard Deviation 3.61
|
9.47 day
Standard Deviation 3.45
|
9.69 day
Standard Deviation 4.5
|
7.94 day
Standard Deviation 2.73
|
11.8 day
Standard Deviation 4.72
|
|
Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a
Total anti-GPR20 antibody: Cycle 3
|
10.7 day
Standard Deviation 3.49
|
10 day
Standard Deviation 4.24
|
13.2 day
Standard Deviation 9.28
|
14.4 day
Standard Deviation 1.66
|
12.7 day
Standard Deviation 4.03
|
—
|
|
Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a
MAAA-1181a: Cycle 1
|
5.05 day
Standard Deviation 1.23
|
4.29 day
Standard Deviation 1.29
|
5.35 day
Standard Deviation 1.39
|
6.52 day
Standard Deviation 3.59
|
4.73 day
Standard Deviation 0.59
|
7.27 day
Standard Deviation 2.77
|
|
Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) for DS-6157a, Total Anti-GPR20 Antibody, and MAAA-1181a Following Intravenous Administration of DS-6157a
MAAA-1181a: Cycle 3
|
5.45 day
Standard Deviation 1.8
|
5.67 day
Standard Deviation 1.06
|
6.37 day
Standard Deviation 1.32
|
7.72 day
Standard Deviation 1.71
|
6.67 day
Standard Deviation 1.98
|
—
|
SECONDARY outcome
Timeframe: Baseline up to long-term follow up (defined as until the start of a new anti-cancer treatment, PD, death, lost to follow up, withdrawal of consent, or at the discretion of the Investigator, whichever occurs first), up to approximately 1 year 10 months.Population: Best overall response was assessed in the Full Analysis Set.
Based on Response Evaluation Criteria In Solid Tumors guidelines, complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions).
Outcome measures
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
n=4 Participants
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
n=4 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
n=5 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
n=13 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
n=6 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
n=2 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation)
Complete response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation)
Partial response (PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation)
Progressive disease (PD)
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation)
Stable disease (SD)
|
2 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
2 Participants
|
0 Participants
|
|
Best Overall Response Rate Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation)
Not evaluable (NE)
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to the date of the first documented radiological progression or death due to any cause, whichever occurs first, up to approximately 1 year 10 monthsPopulation: Progression-free survival was assessed in participants with available data (events) in the Full Analysis Set.
Progression-free survival (PFS) is defined as the time from randomization/start of study treatment to the date of event defined as the first documented radiological progression or death due to any cause.
Outcome measures
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
n=4 Participants
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
n=3 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
n=4 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
n=7 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
n=3 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
n=2 Participants
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Progression-free Survival (PFS) Following Intravenous Administration of DS-6157a in Participants With Advanced Gastrointestinal Stromal Tumors (GIST) (Dose Escalation)
|
2.6 months
Interval 1.2 to
The maximum 95% confidence interval limit could not be estimated due to insufficient number of events for analysis.
|
6.9 months
Interval 5.1 to
The maximum 95% confidence interval limit could not be estimated due to insufficient number of events for analysis.
|
10.4 months
Interval 0.9 to
The maximum 95% confidence interval limit could not be estimated due to insufficient number of events for analysis.
|
4.2 months
Interval 0.8 to
The maximum 95% confidence interval limit could not be estimated due to insufficient number of events for analysis.
|
3.6 months
Interval 1.2 to
The maximum 95% confidence interval limit could not be estimated due to insufficient number of events for analysis.
|
1.5 months
Interval 1.3 to
The maximum 95% confidence interval limit could not be estimated due to insufficient number of events for analysis.
|
SECONDARY outcome
Timeframe: Baseline up to 5 years post-treatmentPopulation: This outcome measure was not assessed due to early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 5 years post-treatmentPopulation: This outcome measure was not assessed due to early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 5 years post-treatmentPopulation: This outcome measure was not assessed due to early study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline up to 5 years post-treatmentPopulation: This outcome measure was not assessed due to early study termination.
Outcome measures
Outcome data not reported
Adverse Events
Dose Escalation: DS-6157a 1.6 mg/kg
Dose Escalation: DS-6157a 3.2 mg/kg
Dose Escalation: DS-6157a 4.8 mg/kg
Dose Escalation: DS-6157a 6.4 mg/kg
Dose Escalation: DS-6157a 9.6 mg/kg
Dose Escalation: DS-6157a 12.8 mg/kg
Serious adverse events
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
n=4 participants at risk
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
n=4 participants at risk
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
n=5 participants at risk
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
n=13 participants at risk
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
n=6 participants at risk
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
n=2 participants at risk
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
33.3%
2/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
Other adverse events
| Measure |
Dose Escalation: DS-6157a 1.6 mg/kg
n=4 participants at risk
Participants with advanced gastrointestinal stromal tumor (GIST) who received an intravenous (IV) infusion of DS-6157a 1.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 3.2 mg/kg
n=4 participants at risk
Participants with advanced GIST who received an IV infusion of DS-6157a 3.2 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 4.8 mg/kg
n=5 participants at risk
Participants with advanced GIST who received an IV infusion of DS-6157a 4.8 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 6.4 mg/kg
n=13 participants at risk
Participants with advanced GIST who received an IV infusion of DS-6157a 6.4 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 9.6 mg/kg
n=6 participants at risk
Participants with advanced GIST who received an IV infusion of DS-6157a 9.6 mg/kg every 3 weeks.
|
Dose Escalation: DS-6157a 12.8 mg/kg
n=2 participants at risk
Participants with advanced GIST who received an IV infusion of DS-6157a 12.8 mg/kg every 3 weeks.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
75.0%
3/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
2/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
80.0%
4/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
46.2%
6/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
3/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
15.4%
2/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Eye disorders
Eye disorder
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
2/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
15.4%
2/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
100.0%
2/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
2/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
40.0%
2/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
38.5%
5/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
33.3%
2/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
100.0%
2/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
23.1%
3/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Gastritis
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Haematemesis
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
75.0%
3/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
60.0%
3/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
84.6%
11/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
100.0%
6/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
100.0%
2/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
2/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
40.0%
2/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
30.8%
4/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
100.0%
2/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
General disorders
Asthenia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
General disorders
Chest discomfort
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
40.0%
2/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
30.8%
4/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
General disorders
Chills
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
General disorders
Fatigue
|
75.0%
3/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
60.0%
3/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
46.2%
6/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
33.3%
2/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
100.0%
2/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
General disorders
Influenza like illness
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
General disorders
Injection site reaction
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
General disorders
Malaise
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
General disorders
Mucosal inflammation
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
60.0%
3/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
100.0%
2/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Infections and infestations
COVID-19
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Infections and infestations
Eye infection
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Injury, poisoning and procedural complications
Contusion
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
15.4%
2/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
23.1%
3/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Alanine aminotransferase
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
2/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
40.0%
2/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
23.1%
3/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
40.0%
2/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
23.1%
3/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
33.3%
2/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
38.5%
5/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
66.7%
4/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
40.0%
2/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
30.8%
4/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
83.3%
5/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Protein total decreased
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
15.4%
2/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
23.1%
3/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
83.3%
5/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
75.0%
3/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
2/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
80.0%
4/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
46.2%
6/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
66.7%
4/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
100.0%
2/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
100.0%
2/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
33.3%
2/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
40.0%
2/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
15.4%
2/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
15.4%
2/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
33.3%
2/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
30.8%
4/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
100.0%
2/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
15.4%
2/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
30.8%
4/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Nervous system disorders
Taste disorder
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
2/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
15.4%
2/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
33.3%
2/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Renal and urinary disorders
Proteinuria
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
23.1%
3/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
23.1%
3/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
33.3%
2/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
2/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
2/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
60.0%
3/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
20.0%
1/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
33.3%
2/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
16.7%
1/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
100.0%
2/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Vascular disorders
Haematoma
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
7.7%
1/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
25.0%
1/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
15.4%
2/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/4 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/5 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
15.4%
2/13 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
0.00%
0/6 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
50.0%
1/2 • Adverse event data were collected from baseline up to 30 days after last administration of study drug, up to approximately 1 year 10 months.
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. AEs were graded according to NCI CTCAE Version 5.0. AEs are only reported for the Dose Escalation phase. The Dose Expansion phase was not conducted since the study terminated early.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place