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A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
Trial Status: active
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).
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.
Additional locations may be listed on ClinicalTrials.gov for NCT06515613.
Locations matching your search criteria
United States
New Jersey
Hackensack
Hackensack University Medical Center
Status: Active
Name Not Available
New York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available
Pennsylvania
Philadelphia
Fox Chase Cancer Center
Status: Active
Name Not Available
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 dosing schedules (n=20 response evaluable participants in each cohort )
in the dose expansion phase of the trial (Phase 1b) studying one of the following
advanced solid tumor types: PROC, testicular, or endometrial. 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.
