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Spots Global Cancer Trial Database for Phase 1 Study of CK-301 (Cosibelimab) as a Single Agent in Subjects With Advanced Cancers

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Trial Identification

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

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

Study ID: NCT03212404

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Research Site, Wollongong, New South Wales, Australia

Research Site, Benowa, Queensland, Australia

Research Site, Buderim, Queensland, Australia

Research Site, Greenslopes, Queensland, Australia

Research Site, South Brisbane, Queensland, Australia

Research Site, Woolloongabba, Queensland, Australia

Research Site, Box Hill, Victoria, Australia

Research Site, Malvern, Victoria, Australia

Research Site, Besançon, , France

Research Site, Bordeaux, , France

Research Site, Grenoble, , France

Research Site, Lyon, , France

Research Site, Nice, , France

Research Site, Christchurch, , New Zealand

Research Site, Kraków, , Poland

Research Site, Lublin, , Poland

Research Site, Poznań, , Poland

Research Site, Warsaw, , Poland

Research Site, Łódź, , Poland

Research Site, Chelyabinsk, , Russian Federation

Research Site, Kazan, , Russian Federation

Research Site, Murmansk, , Russian Federation

Research Site, Novosibirsk, , Russian Federation

Research Site, Omsk, , Russian Federation

Research Site, Saint Petersburg, , Russian Federation

Research Site, Saint Petersburg, , Russian Federation

Research Site, Tyumen, , Russian Federation

Research Site, Volgograd, , Russian Federation

Research Site, Cape Town, , South Africa

Research Site, George, , South Africa

Research Site, Port Elizabeth, , South Africa

Research Site, Pretoria, , South Africa

Research Site, Soweto, , South Africa

Research Site, Barcelona, , Spain

Research Site, La Laguna, , Spain

Research Site, Madrid, , Spain

Research Site, Málaga, , Spain

Research Site, Pamplona, , Spain

Research Site, Sevilla, , Spain

Research Site, Valencia, , Spain

Research Site, Hat Yai, Songkhla, Thailand

Research Site, Bangkok, , Thailand

Research Site, Bangkok, , Thailand

Research Site, Chiang Mai, , Thailand

Research Site, Khon Kaen, , Thailand

Research Site, Chernivtsi, , Ukraine

Research Site, Kharkiv, , Ukraine

Research Site, Sumy, , Ukraine

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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