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

Phase 1

Recruiting

• Conditions: Platinum-resistant Ovarian Cancer; Testicular Cancer; Endometrial Cancer
• Interventions: Drug: CTIM-76

• Registration Number: NCT06515613
• Lead Sponsor: Context Therapeutics Inc.

Brief 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 humanized T cell engaging bispecific antibody targeting CLDN6, in subjects 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 subjects with platinum-resistant/refractory ovarian cancer (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. Subjects will be dosed until documentation of disease progression, unacceptable toxicity, or subject/physician decision.

The phase 1b dose expansion phase will evaluate CTIM-76 in one indication (PRROC, endometrial or testicular) at up to 2 doses (n=15 response evaluable subjects at each dose level). This is to enable dose- and exposure-response analyses. Dosing will follow the same schedule as Phase 1a. A priming dose will be administered on Day 1, and the full cohort dose will be administered weekly thereafter. Expansion doses 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 recommended Phase 2 dose (RP2D) will be based on the totality of data from Phase 1b.

Study Timeline

• Study Start: 2024-07-10
• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-19
• Study First Posted: 2024-07-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2027-07-30
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Subjects with CLDN6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer.
• Subject with measurable disease per RECIST 1.1
• ECOG 0, 1, or 2
• Subjects 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 subject's participation in the study.
• Prior treatment with CLDN-6 targeted therapy.
• Concurrent participation in another investigational clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CTIM-76	CTIM-76	Phase 1a: Dose Escalation-each dose cohort will assess toxicity 28 days following the first dose of CTIM76; anticipate a total of 9 dose cohorts. Phase 1b: Dose Expansion - 30 subjects will be evaluated using 2 different doses of CTIM-76

Primary Outcome Measures

Name	Time	Method
Incidence of Dose Limiting Toxicities (DLTs)	From date of first dose of CTIM-76 until 28 days following the first dose	Phase 1a will evaluate increasing doses of CTIM-76 based on the assessment of DLTs
Overall response rate (ORR)	From date of first dose of CTIM-76 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months	ORR will be based on the best overall response rate as assessed by Investigators according to RECIST v1.1

Trial Locations

Locations (1)

Context Investigational Site; 🇺🇸 Dallas, Texas, United States