An official website of the United States government
Government Funding Lapse Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.
The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.
Updates regarding government operating status and resumption of normal operations can be found at opm.gov.
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 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).
Inclusion Criteria
Subjects with CLDN6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer.
Subject with measurable disease per RECIST 1.1
ECOG 0, 1, or 2
Subjects 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 subject's participation in the study.
Prior treatment with CLDN-6 targeted therapy.
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 subjects with
platinum-resistant/refractory ovarian cancer (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. Subjects will be dosed until
documentation of disease progression, unacceptable toxicity, or subject/physician
decision.
The phase 1b dose expansion phase will evaluate CTIM-76 in one indication (PRROC,
endometrial or testicular) at up to 2 doses (n=15 response evaluable subjects at each
dose level). This is to enable dose- and exposure-response analyses. Dosing will follow
the same schedule as Phase 1a. A priming dose will be administered on Day 1, and the full
cohort dose will be administered weekly thereafter. Expansion doses 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 recommended Phase 2 dose (RP2D) will be based on the totality of
