Recruiting
Phase 1

CTIM-76

Sponsor:

Context Therapeutics Inc.

Code:

NCT06515613

Conditions

Platinum-resistant Ovarian Cancer

Testicular Cancer

Endometrial Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CTIM-76

Study Details

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 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).

Conditions

Platinum-resistant Ovarian Cancer

Testicular Cancer

Endometrial Cancer

Study ID

NCT06515613

Start date

Jul 10, 2024

Status verified date

Sep, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

156 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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 - approximately 80 participants will be evaluated at a minimum of 2 dose levels and/or dosing schedules of CTIM-76

Interventions

CTIM-76

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

Primary outcome measure

  • Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: From date of first dose of CTIM-76 until 28 days following the first dose ]
  • Overall response rate (ORR) [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Context Clinical Development

267-225-7416cntx-ctim76-101@contexttherapeutics.com

Locations

University of Arkansas Winthrop P. Rockefeller Cancer Institute

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Maroof Zafar

501-686-8274MKZafar@uams.edu

SCRI at Denver Health

Recruiting

Denver, Colorado, United States, 80218

Contacts

Front Desk

720-754-2610CANN.DDUDenverGeneral@SarahCannon.com

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Rebecca Porter, MD

877-338-7425Rebecca_Porter@DFCI.HARVARD.EDU

University of Nebraska Medical

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Marnee Strege, RN BSN

402-559-8155

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10021

Contacts

Roisin O'Cearbhaill, MD

ocearbhr@mskcc.org

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Duke Cancer Institute - Phase I and Immunotherapy Trials

919-684-6342Phase1andImmunotherapyreferrals@duke.edu

Providence Cancer Institute of Oregon

Recruiting

Portland, Oregon, United States, 97213

Contacts

Christopher Darus, MD

503-215-2075CanRsrchStudies@Providence.org

Women & Infants Hospital of Rhode Island

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Mary Dionne

401-453-8181MDionne@WIHRI.org

Vanderbilt-Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO)

800-811-8480CTIP@VUMC.ORG

SCRI at Mary Crowley

Recruiting

Dallas, Texas, United States, 75230

Contacts

Angela Hotchkiss

214-658-1958ahotchkiss@marycrowley.org

More Information

Sponsor

Context Therapeutics Inc.

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Context Therapeutics Inc. on 2026-09-03.