This study will investigate OC-001 as monotherapy, and in combination with, Avelumab, in various cancer types
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Administered IV.
Administered IV.
Cross Cancer Institute
Edmonton, Alberta, Canada
Ottawa Hospital Cancer Centre (OHRI)
Ottawa, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
Jewish General Hospital - Clinical Research Unit
Montreal, Quebec, Canada
Number of participants with a Dose Limiting Toxicity (DLT) in Phase 1b
A Dose-Limiting Toxicity (DLT) is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the criteria identified in the Common Terminology Criteria for Adverse Events (CTCAE, Version 5)
Time frame: Baseline through Cycle 1 (Day 28)
Number of participants with any Serious Adverse Event or Treatment-Emergent Adverse Event in Phase 2a
Number of participants with any Serious Adverse Event or Treatment-Emergent Adverse Event in Phase 2a
Time frame: Baseline up to two years
Area Under the OC-001 Plasma Concentration Time Curve (AUC) in Phase 1b
After single and multiple dose administration
Time frame: Baseline through 12 weeks
Maximum Observed OC-001 Concentration (Cmax) in Phase 1b
After single and multiple dose administration
Time frame: Baseline through 12 weeks
Time to reach OC-001 Cmax (Tmax) in Phase 1b
Time of maximum concentration observed
Time frame: Baseline through 12 weeks
Minimum Observed OC-001 Concentration (Cmin) in Phase 1b
After single and multiple dose administration
Time frame: Baseline through 12 weeks
Overall Response Rate (ORR) in Phase 2a
In combination with Avelumab
Time frame: Baseline up to two years
Progression Free Survival (PFS) in Phase 2a
In combination with Avelumab
Time frame: Baseline up to two years
Duration of Response (DOR) in Phase 2a
In combination with Avelumab
Time frame: Baseline up to two years
Time to Response (TTR) in Phase 2a
In combination with Avelumab
Time frame: Baseline up to two years
Disease Control Rate (DCR) in Phase 2a
In combination with Avelumab
Time frame: Baseline up to two years
Overall Survival (OS) in Phase 2a
In combination with Avelumab
Time frame: Baseline up to two years
One-Year Survival Rate in Phase 2a
In combination with Avelumab
Time frame: Baseline up to two years
Maximum Observed OC-001 Concentration (Cmax) in Phase 2a
In combination with Avelumab
Time frame: Baseline through 12 weeks
Minimum Observed OC-001 Concentration (Cmin) in Phase 2a
In combination with Avelumab
Time frame: Baseline through 12 weeks
Trough drug concentration of OC-001 (Ctrough) in Phase 2a
In combination with Avelumab
Time frame: Baseline through 12 weeks
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