Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 80
Summary
- Conditions
- Malignant Mesothelioma, Advanced
- Carcinoma Non-small-cell Lung
- Carcinoma, Small Cell
- Classical Hodgkin Lymphoma
- Cutaneous Squamous Cell Carcinoma
- Endometrial Cancer
- Head and Neck Cancer
- Renal Cell Carcinoma
- Lung Neoplasms
- Melanoma
- Merkel Cell Carcinoma
- Non Hodgkin Lymphoma
- Urothelial Carcinoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 s...
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.
Tracking Information
- NCT #
- NCT03212404
- Collaborators
- Novotech (Australia) Pty Limited
- Investigators
- Not Provided
Get Well Soon