RecruitingPhase 1NCT06515613

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


Sponsor

Context Therapeutics Inc.

Enrollment

80 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase (Phase 1) study is testing a new experimental drug called CTIM-76 in people whose ovarian, testicular, or endometrial cancer has come back or is not responding to standard treatments. The drug targets a protein called CLDN6 found on some cancer cells. The main goal is to find out if the drug is safe and what dose works best. **You may be eligible if...** - You have ovarian cancer that has returned or stopped responding to platinum-based chemotherapy, or advanced testicular or endometrial cancer - Your tumor tests positive for the CLDN6 protein - Your cancer can be measured on imaging scans - You are well enough to carry out daily activities (ECOG 0–2) and have a life expectancy of at least 12 weeks - Your liver, kidneys, and blood counts are in acceptable range **You may NOT be eligible if...** - Cancer has spread to your brain or spinal fluid - You have an active, uncontrolled infection or a serious medical condition that would make participation unsafe - You are already taking part in another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCTIM-76

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


Locations(13)

University of Arkansas Winthrop P. Rockefeller Cancer Institute

Little Rock, Arkansas, United States

Precision NextGen Oncology & Research Center

Beverly Hills, California, United States

SCRI at Denver Health

Denver, Colorado, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

John Theurer Cancer Center

Hackensack, New Jersey, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke Cancer Institute

Durham, North Carolina, United States

Gabrail Cancer Center

Canton, Ohio, United States

Providence Cancer Institute of Oregon

Portland, Oregon, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

SCRI at Mary Crowley

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06515613


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