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A Phase 1a/1b, First-Time-in-Human Study of CT-202, a Nectin-4 Directed Bispecific Antibody, in Participants With Recurring Triple Negative Breast, Colorectal, Urothelial Cancers

RecruitingPhase 1Ages 18 Years - anyAllContext Therapeutics Inc.
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In plain words

What the trial is, and whether it could suit you

This is a Phase 1a/1b, first time in human (FTIH), open-label, dose escalation and expansion study to evaluate the safety, tolerability, and preliminary efficacy of CT-202 (study drug), a humanized T cell engaging bispecific antibody targeting nectin-4, in participants with nectin-4 expressing recurrent, unresectable or metastatic refractory/resistant TNBC, CRC, or UC. Results of the study including PK, PD, efficacy, and safety will be used in the RP2D determination.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Participants with nectin-4-positive triple negative breast cancer, colorectal cancer, or urothelial cancer that have received standard therapies * Participants with measurable disease per RECIST 1.1 * ECOG 0, 1, or 2 and life expectancy of โ‰ฅ 12 weeks * Participants have adequate organ function. Exclusion Criteria: * History of severe skin toxicity * Uncontrolled significant active infection or any medical or other condition that in the opinion of the Investigator would preclude the participant's participation in the study. * Concurrent participation in another investigational clinical trial.
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What it tests

  • CT-202
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Where

6 sites
Sydney Adventist Hospital
Wahroonga, Australia
Crown Princess Mary Cancer Centre Westmead Hospital
Westmead, Australia
Tasman Oncology Research
Gold Coast, Australia
Calvary Mater Hospital Newcastle
Newcastle, Australia
Olivia Newton John Cancer Centre
Heidelberg, Australia
Linear Clinical Research
Perth, Australia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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