Phase 1 Study of CTIM-76, a Claudin-6 Targeted Antibody, for Platinum-Resistant Ovarian, Testicular, and Endometrial Cancers

What this Trial Is About

Researchers are evaluating CTIM-76, a CLDN6-directed T cell-engaging bispecific antibody, in people with platinum-refractory or resistant ovarian cancer and other advanced CLDN6-positive solid tumors such as testicular and endometrial cancers. This Phase 1a1b open-label study aims to assess the safety, tolerability, and effectiveness of CTIM-76 in these patients. The study includes a dose escalation portion to determine the recommended dose for expansion, followed by a dose expansion phase to evaluate different dose levels and schedules. In the dose escalation phase Phase 1a, participants receive CTIM-76 once according to their assigned dose cohort, with about 9 dose groups planned. Treatment continues until disease progression, unacceptable side effects, or a decision to stop by the participant or physician. The dose expansion phase Phase 1b will study at least two dose levels or schedules in approximately 80 participants to better understand the dose-response relationship. The final recommended dose will be selected based on all collected safety, pharmacokinetic, pharmacodynamic, biomarker, and preliminary efficacy data. Participants will be monitored for dose-limiting toxicities within 28 days after the first dose and overall response rate up to 24 months. Assessments include disease measurement per RECIST 1.1 criteria, organ function, and overall health. Safety and response data guide dosing decisions. The total duration of participation depends on treatment continuation and disease progression, with ongoing evaluations throughout the study period ending in 2028.

A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors