A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
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).
Cervical,
Gynecologic,
Ovarian,
Prostate,
Urologic,
Uterine
Phase I
Adults
Mol. targeted/Immunotherapy/Biologics
CTIM-76
Brown, Alaina
National
Vanderbilt University
12-31-2025
Eligibility
18 Years and older
ALL
false
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.
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.
