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
Context Therapeutics Inc.
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).
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 weekly (Q1W) for each cycle. A cycle is defined as 28 days. Participants will be dosed until documentation of disease progression, unacceptable toxicity, or participant/physician decision. The phase 1b dose expansion phase will evaluate CTIM-76 in at least one indication at up to 2 doses and/or dosin…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. * C…
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 InstituteLittle Rock, Arkansas
- Precision NextGen Oncology & Research CenterBeverly Hills, California
- SCRI at Denver HealthDenver, Colorado
- Dana-Farber Cancer InstituteBoston, Massachusetts
- John Theurer Cancer CenterHackensack, New Jersey
- Memorial Sloan Kettering Cancer CenterNew York, New York