Trial Outcomes & Findings for APX005M With Nivolumab and Cabiralizumab in Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma (NCT NCT03502330)
NCT ID: NCT03502330
Last Updated: 2024-07-03
Results Overview
AEs and SAEs will be examined with (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
42 participants
Primary outcome timeframe
From study enrollment up to 12 months.
Results posted on
2024-07-03
Participant Flow
Participant milestones
| Measure |
Cohort 1 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 2 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 3 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 4 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 5 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 6 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 7 Advanced Melanoma
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 8 NSCLC
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 9 RCC
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
THIS STUDY ARM/COHORT WAS NEVER ACTIVATED DURING THE STUDY.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
3
|
5
|
3
|
6
|
8
|
8
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
3
|
5
|
3
|
6
|
8
|
8
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 2 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 3 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 4 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 5 Advanced Solid Tumors
Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 6 Advanced Solid Tumors
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 7 Advanced Melanoma
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 8 NSCLC
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 9 RCC
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
THIS STUDY ARM/COHORT WAS NEVER ACTIVATED DURING THE STUDY.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
5
|
3
|
5
|
1
|
5
|
5
|
6
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
Baseline Characteristics
APX005M With Nivolumab and Cabiralizumab in Advanced Melanoma, Non-small Cell Lung Cancer or Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Cohort 1 Advanced Solid Tumors
n=3 Participants
Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 2 Advanced Solid Tumors
n=6 Participants
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 3 Advanced Solid Tumors
n=3 Participants
Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 4 Advanced Solid Tumors
n=5 Participants
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 5 Advanced Solid Tumors
n=3 Participants
Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 6 Advanced Solid Tumors
n=6 Participants
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 7 Advanced Melanoma
n=8 Participants
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 8 NSCLC
n=8 Participants
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61 years
n=93 Participants
|
58 years
n=4 Participants
|
69 years
n=27 Participants
|
58 years
n=483 Participants
|
61 years
n=36 Participants
|
61 years
n=10 Participants
|
65.5 years
n=115 Participants
|
60.5 years
n=40 Participants
|
61 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
12 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
30 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
8 Participants
n=40 Participants
|
37 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
4 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
6 participants
n=4 Participants
|
3 participants
n=27 Participants
|
5 participants
n=483 Participants
|
3 participants
n=36 Participants
|
6 participants
n=10 Participants
|
8 participants
n=115 Participants
|
8 participants
n=40 Participants
|
42 participants
n=8 Participants
|
|
ECOG PS
0
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
27 Participants
n=8 Participants
|
|
ECOG PS
1
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
6 Participants
n=40 Participants
|
15 Participants
n=8 Participants
|
|
ECOG PS
2
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
ECOG PS
3
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
ECOG PS
4
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
ECOG PS
5
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Cancer Type
Melanoma
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
5 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
20 Participants
n=8 Participants
|
|
Cancer Type
Renal Cell Carcinoma (RCC)
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
13 Participants
n=8 Participants
|
|
Cancer Type
Non-small-cell Lung Cancer (NSCLC)
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
8 Participants
n=40 Participants
|
9 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From study enrollment up to 12 months.AEs and SAEs will be examined with (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 4.03.
Outcome measures
| Measure |
Cohort 1 Advanced Solid Tumors
n=3 Participants
Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 2 Advanced Solid Tumors
n=6 Participants
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 3 Advanced Solid Tumors
n=3 Participants
Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 4 Advanced Solid Tumors
n=5 Participants
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 5 Advanced Solid Tumors
n=3 Participants
Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 6 Advanced Solid Tumors
n=6 Participants
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 7 Advanced Melanoma
n=8 Participants
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 8 NSCLC
n=8 Participants
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability Measured by Assessing Serious Adverse Events (SAEs)and Adverse Events (AEs)
Experienced any SAE
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
|
Safety and Tolerability Measured by Assessing Serious Adverse Events (SAEs)and Adverse Events (AEs)
Experienced any AE
|
3 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
8 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: From study enrollment up to 12 months.This 5-point scale ranges from full functioning (0) to dead (5)
Outcome measures
| Measure |
Cohort 1 Advanced Solid Tumors
n=3 Participants
Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 2 Advanced Solid Tumors
n=6 Participants
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 3 Advanced Solid Tumors
n=3 Participants
Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 4 Advanced Solid Tumors
n=5 Participants
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 5 Advanced Solid Tumors
n=3 Participants
Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 6 Advanced Solid Tumors
n=6 Participants
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 7 Advanced Melanoma
n=8 Participants
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 8 NSCLC
n=8 Participants
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability Measured by Eastern Cooperative Oncology Group(ECOG) Performance Status
0
|
1 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Safety and Tolerability Measured by Eastern Cooperative Oncology Group(ECOG) Performance Status
1
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Six months.Population: Only participants that completed at least 1 follow up assessment.
ORR will be determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria v. 1.1. The RECIST categories used for the target lesion are complete response (CR), partial response (PR), stable disease (NR/SD), and progressive disease (PD).
Outcome measures
| Measure |
Cohort 1 Advanced Solid Tumors
n=3 Participants
Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 2 Advanced Solid Tumors
n=6 Participants
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 3 Advanced Solid Tumors
n=3 Participants
Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 4 Advanced Solid Tumors
n=5 Participants
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 5 Advanced Solid Tumors
n=3 Participants
Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 6 Advanced Solid Tumors
n=5 Participants
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 7 Advanced Melanoma
n=8 Participants
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 8 NSCLC
n=8 Participants
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|
|
Efficacy Measured by Objective Response Rate (ORR)
complete response (CR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Measured by Objective Response Rate (ORR)
partial response (PR)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Efficacy Measured by Objective Response Rate (ORR)
stable disease (SD)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
|
Efficacy Measured by Objective Response Rate (ORR)
progressive disease (PD)
|
1 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksThis outcome will be assessed by blood collection.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksThis outcome will be assessed by blood collection.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksThis outcome will be assessed by blood collection.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksThis outcome will be assessed by blood collection.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksThis outcome will be assessed by blood collection.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 8 weeks.This outcome will be assessed with tissue biopsies.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 8 weeks.This outcome will be assessed with tissue biopsies.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 8 weeks.This outcome will be assessed via blood collection.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 8 weeks.This outcome will be assessed via blood collection.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 8 weeks.This outcome will be assessed via blood collection.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 8 weeks.This outcome will be assessed via blood collection.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Change from baseline to 8 weeks.This outcome will be assessed via blood collection.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment up to 6 years.PFS will be determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria v. 1.1.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From study enrollment up to 6 years.OS will be ascertained by review of the National Death Index, medical records and follow-up phone calls.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 Advanced Solid Tumors
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2 Advanced Solid Tumors
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 3 Advanced Solid Tumors
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4 Advanced Solid Tumors
Serious events: 2 serious events
Other events: 5 other events
Deaths: 5 deaths
Cohort 5 Advanced Solid Tumors
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 6 Advanced Solid Tumors
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort 7 Advanced Melanoma
Serious events: 3 serious events
Other events: 8 other events
Deaths: 2 deaths
Cohort 8 NSCLC
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 Advanced Solid Tumors
n=3 participants at risk
Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 2 Advanced Solid Tumors
n=6 participants at risk
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 3 Advanced Solid Tumors
n=3 participants at risk
Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 4 Advanced Solid Tumors
n=5 participants at risk
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 5 Advanced Solid Tumors
n=3 participants at risk
Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 6 Advanced Solid Tumors
n=6 participants at risk
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 7 Advanced Melanoma
n=8 participants at risk
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 8 NSCLC
n=8 participants at risk
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 2 • Up to 12 months
|
16.7%
1/6 • Number of events 2 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
33.3%
2/6 • Number of events 3 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
General disorders
Fatigue
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
General disorders
Fever
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
20.0%
1/5 • Number of events 2 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Infections and infestations
Meningitis
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Infections and infestations
Periorbital infection
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 2 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Investigations
CPK increased
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
33.3%
1/3 • Number of events 2 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 2 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Nervous system disorders
Stroke
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
20.0%
1/5 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 2 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
Other adverse events
| Measure |
Cohort 1 Advanced Solid Tumors
n=3 participants at risk
Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 2 Advanced Solid Tumors
n=6 participants at risk
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.03 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 3 Advanced Solid Tumors
n=3 participants at risk
Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 4 Advanced Solid Tumors
n=5 participants at risk
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.1 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 5 Advanced Solid Tumors
n=3 participants at risk
Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
Cohort 6 Advanced Solid Tumors
n=6 participants at risk
Nivolumab 240 mg plus Cabiralizumab 4mg/kg plus APX005M 0.3 mg/kg administered in 14 day cycles.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 7 Advanced Melanoma
n=8 participants at risk
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
Nivolumab: Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
|
Cohort 8 NSCLC
n=8 participants at risk
Patients will be treated at the estimated APX005M RP2D in combination with nivolumab 240 mg IV and cabiralizumab 4 mg/kg on day 1 of each 14-day cycle.
APX005M: APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
Cabiralizumab: Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
|
|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/3 • Up to 12 months
|
50.0%
3/6 • Number of events 7 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
20.0%
1/5 • Number of events 3 • Up to 12 months
|
33.3%
1/3 • Number of events 2 • Up to 12 months
|
33.3%
2/6 • Number of events 6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
25.0%
2/8 • Number of events 5 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
25.0%
2/8 • Number of events 4 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
66.7%
2/3 • Number of events 2 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Number of events 3 • Up to 12 months
|
100.0%
6/6 • Number of events 24 • Up to 12 months
|
66.7%
2/3 • Number of events 3 • Up to 12 months
|
60.0%
3/5 • Number of events 15 • Up to 12 months
|
100.0%
3/3 • Number of events 11 • Up to 12 months
|
83.3%
5/6 • Number of events 22 • Up to 12 months
|
62.5%
5/8 • Number of events 22 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
25.0%
2/8 • Number of events 2 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Eye disorders
Eye disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
25.0%
2/8 • Number of events 2 • Up to 12 months
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Eye disorders
Periorbital edema
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
37.5%
3/8 • Number of events 3 • Up to 12 months
|
50.0%
4/8 • Number of events 8 • Up to 12 months
|
|
Eye disorders
Uveitis
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Eye disorders
Watering eyes
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
20.0%
1/5 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
33.3%
2/6 • Number of events 2 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
33.3%
2/6 • Number of events 2 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
20.0%
1/5 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
37.5%
3/8 • Number of events 3 • Up to 12 months
|
25.0%
2/8 • Number of events 2 • Up to 12 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
66.7%
2/3 • Number of events 2 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 2 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
25.0%
2/8 • Number of events 2 • Up to 12 months
|
37.5%
3/8 • Number of events 10 • Up to 12 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
20.0%
1/5 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
25.0%
2/8 • Number of events 2 • Up to 12 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
20.0%
1/5 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Gastrointestinal disorders
Nausea
|
66.7%
2/3 • Number of events 3 • Up to 12 months
|
33.3%
2/6 • Number of events 2 • Up to 12 months
|
33.3%
1/3 • Number of events 2 • Up to 12 months
|
20.0%
1/5 • Number of events 1 • Up to 12 months
|
66.7%
2/3 • Number of events 3 • Up to 12 months
|
33.3%
2/6 • Number of events 2 • Up to 12 months
|
37.5%
3/8 • Number of events 3 • Up to 12 months
|
75.0%
6/8 • Number of events 12 • Up to 12 months
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 2 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
25.0%
2/8 • Number of events 2 • Up to 12 months
|
37.5%
3/8 • Number of events 4 • Up to 12 months
|
|
General disorders
Chills
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
66.7%
2/3 • Number of events 2 • Up to 12 months
|
66.7%
4/6 • Number of events 4 • Up to 12 months
|
50.0%
4/8 • Number of events 4 • Up to 12 months
|
50.0%
4/8 • Number of events 8 • Up to 12 months
|
|
General disorders
Edema face
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
66.7%
2/3 • Number of events 3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
General disorders
Edema limbs
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
General disorders
Fatigue
|
100.0%
3/3 • Number of events 4 • Up to 12 months
|
33.3%
2/6 • Number of events 2 • Up to 12 months
|
66.7%
2/3 • Number of events 3 • Up to 12 months
|
80.0%
4/5 • Number of events 4 • Up to 12 months
|
66.7%
2/3 • Number of events 2 • Up to 12 months
|
83.3%
5/6 • Number of events 5 • Up to 12 months
|
75.0%
6/8 • Number of events 8 • Up to 12 months
|
87.5%
7/8 • Number of events 17 • Up to 12 months
|
|
General disorders
Fever
|
0.00%
0/3 • Up to 12 months
|
33.3%
2/6 • Number of events 4 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
100.0%
3/3 • Number of events 4 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
62.5%
5/8 • Number of events 6 • Up to 12 months
|
25.0%
2/8 • Number of events 2 • Up to 12 months
|
|
General disorders
Flu like symptoms
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
66.7%
2/3 • Number of events 4 • Up to 12 months
|
33.3%
2/6 • Number of events 4 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
20.0%
1/5 • Number of events 1 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
12.5%
1/8 • Number of events 3 • Up to 12 months
|
|
General disorders
Infusion related reaction
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
General disorders
Pain
|
66.7%
2/3 • Number of events 2 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
20.0%
1/5 • Number of events 1 • Up to 12 months
|
66.7%
2/3 • Number of events 4 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
25.0%
2/8 • Number of events 2 • Up to 12 months
|
37.5%
3/8 • Number of events 3 • Up to 12 months
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
40.0%
2/5 • Number of events 3 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
33.3%
2/6 • Number of events 2 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 2 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Infections and infestations
Lung infection
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
20.0%
1/5 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Infections and infestations
Rhinitis infective
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Infections and infestations
Thrush
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 3 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Up to 12 months
|
50.0%
3/6 • Number of events 6 • Up to 12 months
|
100.0%
3/3 • Number of events 10 • Up to 12 months
|
60.0%
3/5 • Number of events 13 • Up to 12 months
|
100.0%
3/3 • Number of events 7 • Up to 12 months
|
100.0%
6/6 • Number of events 22 • Up to 12 months
|
37.5%
3/8 • Number of events 4 • Up to 12 months
|
50.0%
4/8 • Number of events 9 • Up to 12 months
|
|
Investigations
Alkaline phosphatase increased
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
83.3%
5/6 • Number of events 8 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
40.0%
2/5 • Number of events 5 • Up to 12 months
|
66.7%
2/3 • Number of events 3 • Up to 12 months
|
66.7%
4/6 • Number of events 8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
3/3 • Number of events 6 • Up to 12 months
|
83.3%
5/6 • Number of events 11 • Up to 12 months
|
100.0%
3/3 • Number of events 12 • Up to 12 months
|
100.0%
5/5 • Number of events 24 • Up to 12 months
|
100.0%
3/3 • Number of events 18 • Up to 12 months
|
100.0%
6/6 • Number of events 36 • Up to 12 months
|
37.5%
3/8 • Number of events 9 • Up to 12 months
|
100.0%
8/8 • Number of events 24 • Up to 12 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
66.7%
2/3 • Number of events 3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
37.5%
3/8 • Number of events 3 • Up to 12 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
66.7%
2/3 • Number of events 2 • Up to 12 months
|
66.7%
4/6 • Number of events 5 • Up to 12 months
|
66.7%
2/3 • Number of events 2 • Up to 12 months
|
20.0%
1/5 • Number of events 1 • Up to 12 months
|
100.0%
3/3 • Number of events 3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Investigations
Cholesterol high
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Investigations
CPK increased
|
100.0%
3/3 • Number of events 15 • Up to 12 months
|
83.3%
5/6 • Number of events 16 • Up to 12 months
|
100.0%
3/3 • Number of events 11 • Up to 12 months
|
100.0%
5/5 • Number of events 17 • Up to 12 months
|
100.0%
3/3 • Number of events 8 • Up to 12 months
|
100.0%
6/6 • Number of events 19 • Up to 12 months
|
12.5%
1/8 • Number of events 2 • Up to 12 months
|
37.5%
3/8 • Number of events 5 • Up to 12 months
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
20.0%
1/5 • Number of events 2 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
25.0%
2/8 • Number of events 5 • Up to 12 months
|
37.5%
3/8 • Number of events 3 • Up to 12 months
|
|
Investigations
GGT increased
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Investigations
INR increased
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 4 • Up to 12 months
|
37.5%
3/8 • Number of events 5 • Up to 12 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
25.0%
2/8 • Number of events 3 • Up to 12 months
|
|
Investigations
Serum amylase increased
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
25.0%
2/8 • Number of events 2 • Up to 12 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
20.0%
1/5 • Number of events 1 • Up to 12 months
|
66.7%
2/3 • Number of events 2 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
37.5%
3/8 • Number of events 5 • Up to 12 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
2/3 • Number of events 2 • Up to 12 months
|
33.3%
2/6 • Number of events 2 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
12.5%
1/8 • Number of events 2 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 2 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Number of events 4 • Up to 12 months
|
33.3%
2/6 • Number of events 2 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
20.0%
1/5 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
37.5%
3/8 • Number of events 3 • Up to 12 months
|
12.5%
1/8 • Number of events 2 • Up to 12 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
16.7%
1/6 • Number of events 3 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
25.0%
2/8 • Number of events 2 • Up to 12 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Psychiatric disorders
Irritability
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
20.0%
1/5 • Number of events 2 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Renal and urinary disorders
Urinary frequency
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
25.0%
2/8 • Number of events 2 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
25.0%
2/8 • Number of events 2 • Up to 12 months
|
37.5%
3/8 • Number of events 3 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 2 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
25.0%
2/8 • Number of events 3 • Up to 12 months
|
50.0%
4/8 • Number of events 4 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
20.0%
1/5 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
20.0%
1/5 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
20.0%
1/5 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Bullous dermatitis
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
66.7%
2/3 • Number of events 2 • Up to 12 months
|
66.7%
4/6 • Number of events 5 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
40.0%
2/5 • Number of events 3 • Up to 12 months
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
33.3%
2/6 • Number of events 2 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
25.0%
2/8 • Number of events 2 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
1/3 • Number of events 1 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
66.7%
2/3 • Number of events 2 • Up to 12 months
|
40.0%
2/5 • Number of events 2 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/3 • Up to 12 months
|
50.0%
3/6 • Number of events 5 • Up to 12 months
|
66.7%
2/3 • Number of events 3 • Up to 12 months
|
40.0%
2/5 • Number of events 2 • Up to 12 months
|
66.7%
2/3 • Number of events 2 • Up to 12 months
|
50.0%
3/6 • Number of events 3 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
25.0%
2/8 • Number of events 2 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
25.0%
2/8 • Number of events 2 • Up to 12 months
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
20.0%
1/5 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
16.7%
1/6 • Number of events 1 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
20.0%
1/5 • Number of events 1 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
37.5%
3/8 • Number of events 4 • Up to 12 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
37.5%
3/8 • Number of events 5 • Up to 12 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/5 • Up to 12 months
|
0.00%
0/3 • Up to 12 months
|
0.00%
0/6 • Up to 12 months
|
0.00%
0/8 • Up to 12 months
|
12.5%
1/8 • Number of events 1 • Up to 12 months
|
Additional Information
Harriet Kluger, MD
Harvey and Kate Cushing Professor of Medicine (Oncology) and of Dermatology; Director, Yale SPORE in Skin Cancer, Yale Cancer Center
Phone: (203) 200-6622
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place