RECRUITING

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

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Conditions

Platinum-resistant Ovarian CancerTesticular CancerEndometrial Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2024-07-10
Study Completion:2028-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06515613

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants with CLDN6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer.
  2. * Participants with measurable disease per RECIST 1.1.
  3. * ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks.
  4. * Participants with adequate organ function.
  1. * Evidence of central nervous system metastases, leptomeningeal disease or spinal cord compression.
  2. * 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.
  3. * Concurrent participation in another investigational clinical trial.

Contacts and Locations

Study Contact

MaryBeth LeRose
CONTACT
267-225-7416
clinical@contexttherapeutics.com

Principal Investigator

Karen Chagin, MD
STUDY_CHAIR
Context Therapeutics Inc.

Study Locations (Sites)

University of Arkansas Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, 72205
United States
Precision NextGen Oncology & Research Center
Beverly Hills, California, 90212
United States
SCRI at Denver Health
Denver, Colorado, 80218
United States
John Theurer Cancer Center
Hackensack, New Jersey, 07601
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
United States
Gabrail Cancer Center
Canton, Ohio, 44718
United States
Providence Cancer Institute of Oregon
Portland, Oregon, 97213
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
United States
SCRI at Mary Crowley
Dallas, Texas, 75230
United States

Collaborators and Investigators

Sponsor: Context Therapeutics Inc.

  • Karen Chagin, MD, STUDY_CHAIR, 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 Registration Dates

Study Start Date2024-07-10
Study Completion Date2028-04-30

Study Record Updates

Study Start Date2024-07-10
Study Completion Date2028-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Platinum-resistant Ovarian Cancer
  • Testicular Cancer
  • Endometrial Cancer