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

May 29, 2026 updated by: Context Therapeutics Inc.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 according to the dose and schedule of the assigned cohort. Participants will be dosed until documentation of disease progression, unacceptable toxicity, or participant/physician decision.

The phase 1b dose expansion phase will first evaluate CTIM-76 in PRROC at minimum, 2 dose levels and/or dosing schedules will be evaluated (n=20 response evaluable participants in each cohort) in the dose expansion phase of the trial. . 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.

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • University of Arkansas Winthrop P. Rockefeller Cancer Institute
        • Contact:
    • California
      • Beverly Hills, California, United States, 90212
        • Withdrawn
        • Precision NextGen Oncology & Research Center
    • Colorado
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Terminated
        • John Theurer Cancer Center
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Canton, Ohio, United States, 44718
        • Withdrawn
        • Gabrail Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97213
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Withdrawn
        • Fox Chase Cancer Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Women & Infants Hospital of Rhode Island
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt-Ingram Cancer Center
        • Contact:
          • Vanderbilt-Ingram Cancer Center Clinical Trials Office (CTO)
          • Phone Number: 800-811-8480
          • Email: CTIP@VUMC.ORG
    • Texas
      • Dallas, Texas, United States, 75230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: CTIM-76
CLDN6 bispecific Antibody administered weekly (Day 1, 8, 15 and 22) of a 28-day treatment cycle until disease progression.
Other Names:
  • CTIM-76 Claudin 6 bispecific Antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Dose Limiting Toxicities (DLTs)
Time Frame: 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
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
ORR will be based on the best overall response rate as assessed by Investigators according to RECIST v1.1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Context Therapeutics Inc.

Investigators

  • Study Chair: Karen Chagin, MD, Context Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2024

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

July 16, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNTX-CTIM76-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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