CK-301 (cosibelimab) is a fully human monoclonal antibody of IgG1 subtype that directly binds to Programmed Death-Ligand 1 (PD-L1) and blocks its interactions with the Programmed Death-1 (PD-1) and B7.1 receptors. The primary objectives of this study are to assess the safety, tolerability and efficacy of CK-301 when administered intravenously as a single agent to subjects with selected recurrent or metastatic cancers.
This is a first-in-human, Phase 1, open-label, multicenter, dose-escalation study of CK-301 (cosibelimab), a fully human monoclonal IgG1 antibody targeting PD-L1. The study will consist of 3 periods: Screening (up to 28 days), Treatment (28-day cycles), and Follow-up (up to 6 months of visits with survival follow-up for select cohorts). Following the dose escalation portion of the study, additional evaluable subjects may be included in order to further characterize safety and efficacy at selected doses and/or in specific patient sub-groups.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
272
CK-301 will be administered in periods of 28-day cycles.
Research Site
Wollongong, New South Wales, Australia
Research Site
Benowa, Queensland, Australia
Research Site
Buderim, Queensland, Australia
Research Site
Greenslopes, Queensland, Australia
Research Site
South Brisbane, Queensland, Australia
Research Site
Dose Limiting Toxicity
Time frame: Up to 4 weeks
Number of subjects with Treatment-Emergent Adverse Events according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 (or most current version)
Time frame: Screening through 4 weeks after study completion, an average of 6 months
Confirmed Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)
Time frame: Part 2 Only: Average of 6 months
Confirmed Best Overall Response (BOR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)
Time frame: Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months
Duration of Response (DoR) as per Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1)
Time frame: Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months
Objective response rate and duration of response (DOR) based on Modified RECIST 1.1 for immune based therapeutics
Time frame: Part 2 Only: Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months
Overall Survival (OS)
Time frame: Part 2 Only: Every 8 weeks for first 32 weeks, then 12 weeks through study completion, an average of 6 months
Pharmacokinetic parameter: AUC (0-t) of CK-301
Time frame: Baseline up to 12 weeks after study completion, an average of 6 months
Pharmacokinetic parameter: AUC (0-infinity) of CK-301
Time frame: Baseline up to 12 weeks after study completion, an average of 6 months
Pharmacokinetic parameter: Cmax of CK-301
Time frame: Baseline up to 12 weeks after study completion, an average of 6 months
Pharmacokinetic parameter: Tmax of CK-301
Time frame: Baseline up to 12 weeks after study completion, an average of 6 months
Pharmacokinetic parameter: T(1/2) of CK-301
Time frame: Baseline up to 12 weeks after study completion, an average of 6 months
Number of subjects with anti-CK-301 antibodies
Time frame: Baseline up to 12 weeks after study completion, an average of 6 months
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Woolloongabba, Queensland, Australia
Research Site
Box Hill, Victoria, Australia
Research Site
Malvern, Victoria, Australia
Research Site
Besançon, France
Research Site
Bordeaux, France
...and 38 more locations