NCT06515613 A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
| NCT ID | NCT06515613 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Context Therapeutics Inc. |
| Condition | Platinum-resistant Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 156 participants |
| Start Date | 2024-07-10 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 156 participants in total. It began in 2024-07-10 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Karen Chagin, MD
STUDY CHAIR
Context Therapeutics Inc.
Frequently Asked Questions
Who can join the NCT06515613 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Platinum-resistant Ovarian Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06515613 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06515613 currently recruiting?
Yes, NCT06515613 is actively recruiting participants. Contact the research team at cntx-ctim76-101@contexttherapeutics.com for enrollment information.
Where is the NCT06515613 trial being conducted?
This trial is being conducted at Little Rock, United States, Beverly Hills, United States, Denver, United States, Boston, United States and 11 additional locations.
Who is sponsoring the NCT06515613 clinical trial?
NCT06515613 is sponsored by Context Therapeutics Inc.. The principal investigator is Karen Chagin, MD at Context Therapeutics Inc.. The trial plans to enroll 156 participants.
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