A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorContext Therapeutics Inc.
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- CTIM-76
Treatment groups
156 Participants
are divided into 1 treatment groupLocations
14United Kingdom
University College London Hospital London United Kingdom
United States
Arkansas
University of Arkansas Winthrop P. Rockefeller Cancer Institute72205, Little Rock United States
California
Precision NextGen Oncology & Research Center90212, Beverly Hills United States
Colorado
SCRI at Denver Health80218, Denver United States
Sponsors and collaborators
Context Therapeutics Inc.
Lead sponsor
Source ClinicalTrials.gov