A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CTIM-76.
- Who it may be relevant to
- Registry conditions: Platinum-resistant Ovarian Cancer, Testicular Cancer, Endometrial Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
Detailed 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 according to the dose and schedule of the assigned cohort. Participants will be dosed until documentation of disease progression, unacceptable toxicity, or participant/physician decision.
The phase 1b dose expansion phase will first evaluate CTIM-76 in PRROC at minimum, 2 dose levels and/or dosing schedules will be evaluated (n=20 response evaluable participants in each cohort) in the dose expansion phase of the trial. . 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.
Interventions
- Drug CTIM-76
CLDN6 bispecific Antibody administered weekly (Day 1, 8, 15 and 22) of a 28-day treatment cycle until disease progression.
Primary outcome measures
- Incidence of Dose Limiting Toxicities (DLTs) [Time frame: From date of first dose of CTIM-76 until 28 days following the first dose]
- Overall response rate (ORR) [Time frame: From date of first dose of CTIM-76 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 13 centers
- University of Arkansas Winthrop P. Rockefeller Cancer Institute — Little Rock
- Precision NextGen Oncology & Research Center — Beverly Hills
- SCRI at Denver Health — Denver
- Dana-Farber Cancer Institute — Boston
- John Theurer Cancer Center — Hackensack
- Memorial Sloan Kettering Cancer Center — New York
- Duke Cancer Institute — Durham
- Gabrail Cancer Center — Canton
- … and 5 more centers
United Kingdom · 1 center
- University College London Hospital — London
Identifiers
NCT: NCT06515613 · CNTX-CTIM76-101