Clinical Trials in the UK / NCT06515613
Recruiting
Phase 1
A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
NCT06515613 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Platinum-resistant Ovarian CancerTesticular CancerEndometrial Cancer
Investigational drug(s) / intervention(s)
CTIM-76
CTIM-76: CLDN6 bispecific Antibody administered weekly (Day 1, 8, 15 and 22) of a 28-day treatment cycle until disease progression.
Study 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).
Eligibility
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.
Primary outcome measure(s)
- Incidence of Dose Limiting Toxicities (DLTs) — From date of first dose of CTIM-76 until 28 days following the first dose
Phase 1a will evaluate increasing doses of CTIM-76 based on the assessment of DLTs - Overall response rate (ORR) — 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
ORR will be based on the best overall response rate as assessed by Investigators according to RECIST v1.1
Trial sites (15)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Arkansas Winthrop P. Rockefeller Cancer Institute | Little Rock | Arkansas | Recruiting |
| Precision NextGen Oncology & Research Center | Beverly Hills | California | Withdrawn |
| SCRI at Denver Health | Denver | Colorado | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| University of Nebraska Medical | Omaha | Nebraska | Recruiting |
| John Theurer Cancer Center | Hackensack | New Jersey | Terminated |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Duke Cancer Institute | Durham | North Carolina | Recruiting |
| Gabrail Cancer Center | Canton | Ohio | Withdrawn |
| Providence Cancer Institute of Oregon | Portland | Oregon | Recruiting |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | Withdrawn |
| Women & Infants Hospital of Rhode Island | Providence | Rhode Island | Recruiting |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | Recruiting |
| SCRI at Mary Crowley | Dallas | Texas | Recruiting |
| University College London Hospital | London | United Kingdom | Recruiting |
Other trials for the same condition
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Participants With Endometrial Cancer After Platinum-Based Chemotherapy and Immunotherapy (ASCENT-GYN-01/GOG-3104/ENGOT-en26)
Active, not recruiting
Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)
Active, not recruiting
Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06515613 on ClinicalTrials.gov ↗ ← All trials in the UK