A Phase 1, First in Human Study of CTIM-76, a Claudin-6 (CLDN6)-Directed Bispecific Antibody, in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
Context Therapeutics Inc.
Summary
This is a Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety and efficacy of CTIM-76 (study drug), a CLDN6-directed T cell-engaging bispecific antibody , in participants with platinum-refractory/resistant ovarian cancer (PRROC) and other advanced CLDN6-positive solid tumors (i.e., testicular and endometrial).
Description
The phase 1a dose escalation portion of the trial will enroll participants with PRROC, testicular, or endometrial cancer into one of approximately 9 dose escalation cohorts to assess safety, tolerability and to determine the recommended dose for expansion (RDE). CTIM-76 is to be administered once according to the dose and schedule of the assigned cohort. Participants will be dosed until documentation of disease progression, unacceptable toxicity, or participant/physician decision. The phase 1b dose expansion phase will first evaluate CTIM-76 in PRROC at minimum, 2 dose levels and/or dosing sc…