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

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

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).

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 schedules will be evaluated (n=20 response evaluable participants in each cohort) in the dose expansion phase of the trial. . This is to enable dose- and exposure-response analyses. The expansion doses/dosing schedules for Phase 1b will be determined by Sponsor in conjunction with Safety Review Committee (SRC) based upon all available safety, pharmacokinetic (PK), pharmacodynamic (PD), biomarker and preliminary efficacy data from Phase 1a.

The selection of the RP2D will be based on the totality of data from Phase 1b.

Inclusion Criteria:

• Participants with CLDN6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer.
• Participants with measurable disease per RECIST 1.1.
• ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks.
• Participants with adequate organ function.

Exclusion Criteria:

• Evidence of central nervous system metastases, leptomeningeal disease or spinal cord compression.
• Uncontrolled significant active infection or any medical or other condition that in opinion of the Investigator would preclude the participant's participation in the study.
• Concurrent participation in another investigational clinical trial.