NCT06515613

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Context Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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 weekly (Q1W) for each cycle. A cycle is defined as 28 days. Participants will be dosed until documentation of disease progression, unacceptable toxicity, or participant/physician decision. The phase 1b dose expansion phase will evaluate CTIM-76 in at least one indication at up to 2 doses and/or dosing schedules (n=20 response evaluable participants in each cohort ) in the dose expansion phase of the trial (Phase 1b) studying one of the following advanced solid tumor types: PROC, testicular, or endometrial. 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.

Conditions

• Platinum-resistant Ovarian Cancer
• Testicular Cancer
• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	CTIM-76	CLDN6 bispecific Antibody administered weekly (Day 1, 8, 15 and 22) of a 28-day treatment cycle until disease progression.

Timeline

• Start date: 2024-07-10
• Primary completion: 2027-04-30
• Completion: 2028-04-30
• First posted: 2024-07-23
• Last updated: 2026-04-13

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study