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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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