Last updated on August 2020

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


Brief description of study

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 Study 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.

Clinical Study Identifier: NCT03212404

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Wollongong, Australia
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Box Hill, Australia
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Malvern, Australia
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Christchurch, New Zealand
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Benowa, Australia
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Buderim, Australia
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Greenslopes, Australia
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South Brisbane, Australia
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Woolloongabba, Australia
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Chelyabinsk, Russian Federation
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Kazan, Russian Federation
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Murmansk, Russian Federation
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Novosibirsk, Russian Federation
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Omsk, Russian Federation
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Saint Petersburg, Russian Federation
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Tyumen, Russian Federation
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Volgograd, Russian Federation
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Hat Yai, Thailand
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Bangkok, Thailand
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Chiang Mai, Thailand
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Khon Kaen, Thailand
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Cape Town, South Africa
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George, South Africa
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Pretoria, South Africa
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Soweto, South Africa
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Chernivtsi, Ukraine
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Kharkiv, Ukraine
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Recruitment Status: Open


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