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Active Not RecruitingNCT03212404

Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers

A Phase 1, Open-label, Multicenter, Dose-escalation Study of CK-301 Administered Intravenously as a Single Agent to Subjects With Advanced Cancers

Status
Active Not Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
272 (actual)
Sponsor
Checkpoint Therapeutics, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGCK-301 (cosibelimab)CK-301 will be administered in periods of 28-day cycles.

Timeline

Start date
2017-09-20
Primary completion
2021-11-18
Completion
2025-12-01
First posted
2017-07-11
Last updated
2025-02-03

Locations

48 sites across 9 countries: Australia, France, New Zealand, Poland, Russia, South Africa, Spain, Thailand, Ukraine

Regulatory

Source: ClinicalTrials.gov record NCT03212404. Inclusion in this directory is not an endorsement.