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A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors

RECRUITINGPhase 1Sponsored by Context Therapeutics Inc.
Actively Recruiting
PhasePhase 1
SponsorContext Therapeutics Inc.
Started2024-07-10
Est. completion2027-04-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations13 sites
View on ClinicalTrials.gov →

NCT06515613

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions4

CancerEndometrial CancerPlatinum-resistant Ovarian CancerTesticular Cancer

Locations13 sites

University of Arkansas Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, 72205
Maroof Zafar501-686-8274MKZafar@uams.edu
Precision NextGen Oncology & Research Center
Beverly Hills, California, 90212
SCRI at Denver Health
Denver, Colorado, 80218
Front Desk720-754-2610CANN.DDUDenverGeneral@SarahCannon.com
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Rebecca Porter, MD(877) 338-7425Rebecca_Porter@DFCI.HARVARD.EDU
John Theurer Cancer Center
Hackensack, New Jersey, 07601
Oncology Clinical Research Referral Office551-996-1777OncologyResearchReferral@hmhn.org

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