RECRUITING

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

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 humanized T cell engaging bispecific antibody targeting CLDN6, in subjects 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:2028-03-31
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. * Subjects with CLDN6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer.
  2. * Subject with measurable disease per RECIST 1.1
  3. * ECOG 0, 1, or 2
  4. * Subjects 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 subject's participation in the study.
  3. * Prior treatment with CLDN-6 targeted therapy.
  4. * Concurrent participation in another investigational clinical trial.

Contacts and Locations

Study Contact

Karen Andreas
CONTACT
267-225-7416
clinical@contexttherapeutics.com

Principal Investigator

Claudio Dansky Ullmann, MD
STUDY_CHAIR
Context Therapeutics Inc.

Study Locations (Sites)

Context Investigational Site
Beverly Hills, California, 90212
United States
Context Investigational Site
New York City, New York, 10021
United States
Context Investigational Site
Canton, Ohio, 44718
United States
Context Investigational Site
Dallas, Texas, 75230
United States

Collaborators and Investigators

Sponsor: Context Therapeutics Inc.

  • Claudio Dansky Ullmann, 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 Date2028-03-31

Study Record Updates

Study Start Date2024-07-10
Study Completion Date2028-03-31

Terms related to this study

Additional Relevant MeSH Terms

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