NCT06515613RecruitingPhase 1
A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
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
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 156 (estimated)
- First submitted
- 16 Jul 2024
- Start date
- 10 Jul 2024
- Primary completion date
- 31 May 2028
- Lead sponsor
- Context Therapeutics Inc.
- Diseases
- Endometrial cancer, Ovarian cancer
- NCT number
- NCT06515613
- EU CT number
- 2025-523968-20-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 156
- From 10 Jul 2024 to the primary completion date, 31 May 2028
- 24 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another investigational clinical trial.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice Cedex 2 | France | Not yet recruiting |
| Centre De Lutte Contre Le Cancer Eugene Marquis Coordinator of this site? Confirm its status | Rennes Cedex | France | Not yet recruiting |
| Institut De Cancerologie De L Ouest Coordinator of this site? Confirm its status | Saint-Herblain Cedex | France | Not yet recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Not yet recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Not yet recruiting |
| University College London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Precision NextGen Oncology & Research Center Coordinator of this site? Confirm its status | Beverly Hills | United States | Withdrawn |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Gabrail Cancer Center Coordinator of this site? Confirm its status | Canton | United States | Withdrawn |
| SCRI at Mary Crowley Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| SCRI at Denver Health Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Duke Cancer Institute Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| John Theurer Cancer Center Coordinator of this site? Confirm its status | Hackensack | United States | Terminated |
| University of Arkansas - Winthrop P. Rockefeller Cancer Institute Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Vanderbilt-Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of Nebraska Medical Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Withdrawn |
| Providence Cancer Institute of Oregon Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Women & Infants Hospital of Rhode Island Coordinator of this site? Confirm its status | Providence | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.