Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers
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- STATUS
- Recruiting
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- End date
- Dec 10, 2023
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- participants needed
- 500
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- sponsor
- Checkpoint Therapeutics, Inc.
Summary
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.
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 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.
Details
| Condition | Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small Cell, Malignant Mesothelioma, Advanced, Head and Neck Cancer, Melanoma, Merkel Cell Carcinoma, Renal Cell Carcinoma, Urothelial Carcinoma, Classical Hodgkin Lymphoma, Cutaneous Squamous Cell Carcinoma, Non Hodgkin Lymphoma, Endometrial Cancer |
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| Treatment | CK-301, CK-301 (cosibelimab) |
| Clinical Study Identifier | NCT03212404 |
| Sponsor | Checkpoint Therapeutics, Inc. |
| Last Modified on | 10 March 2022 |
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