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

Context Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Endometrial Cancer; Testicular Cancer; Platinum-resistant Ovarian Cancer

Treatments: Drug: CTIM-76

Study type: Interventional

Funder types: Industry

Identifiers

NCT06515613

CNTX-CTIM76-101

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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80 participants in 1 patient group

CTIM-76

Experimental group

Description:

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 - 40 subjects will be evaluated using 2 different doses/dosing schedules of CTIM-76

Treatment:

Drug: CTIM-76