Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers
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ClinicalTrials.gov Identifier: NCT03212404 |
Recruitment Status :
Recruiting
First Posted : July 11, 2017
Last Update Posted : August 29, 2023
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Sponsor:
Checkpoint Therapeutics, Inc.
Collaborator:
Novotech (Australia) Pty Limited
Information provided by (Responsible Party):
Checkpoint Therapeutics, Inc.
Tracking Information | |||||||
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First Submitted Date ICMJE | July 6, 2017 | ||||||
First Posted Date ICMJE | July 11, 2017 | ||||||
Last Update Posted Date | August 29, 2023 | ||||||
Actual Study Start Date ICMJE | September 20, 2017 | ||||||
Actual Primary Completion Date | November 18, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers | ||||||
Official Title ICMJE | A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects With Advanced Cancers | ||||||
Brief 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. | ||||||
Detailed 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. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: CK-301 (cosibelimab)
CK-301 will be administered in periods of 28-day cycles.
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Study Arms ICMJE | Experimental: CK-301 (cosibelimab)
Part 1 - Dose Escalation; Part 2 - Dose Expansion
Intervention: Drug: CK-301 (cosibelimab)
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
500 | ||||||
Original Estimated Enrollment ICMJE |
80 | ||||||
Estimated Study Completion Date ICMJE | December 2024 | ||||||
Actual Primary Completion Date | November 18, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Spain, Australia, France, New Zealand, Poland, Russian Federation, South Africa, Thailand, Ukraine | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03212404 | ||||||
Other Study ID Numbers ICMJE | CK-301-101 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Current Responsible Party | Checkpoint Therapeutics, Inc. | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor ICMJE | Checkpoint Therapeutics, Inc. | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Novotech (Australia) Pty Limited | ||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | Checkpoint Therapeutics, Inc. | ||||||
Verification Date | August 2023 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |