Actively Recruiting
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
Led by Context Therapeutics Inc. · Updated on 2026-06-02
156
Participants Needed
13
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating CTIM-76, a CLDN6-directed T cell-engaging bispecific antibody, in a Phase 1a/1b open-label study for participants with platinum-refractory or resistant ovarian cancer and other advanced CLDN6-positive solid tumors like testicular and endometrial cancers. The study aims to assess the safety, tolerability, and preliminary efficacy of this investigational drug in these patients. The study includes a Phase 1a dose escalation portion where participants receive CTIM-76 once weekly on days 1, 8, 15, and 22 of a 28-day cycle, across approximately nine dose cohorts to determine the recommended dose for expansion. The Phase 1b dose expansion will evaluate at least two dose levels or dosing schedules in about 80 participants to analyze dose and exposure responses. Participants continue treatment until disease progression, unacceptable toxicity, or decision to stop treatment. Participants will undergo evaluation for dose-limiting toxicities during the first 28 days after the first dose and overall response rates up to 24 months. Assessments include measures of disease progression and safety monitoring. The study involves regular dosing cycles and ongoing observation to collect pharmacokinetic, pharmacodynamic, biomarker, and efficacy data. Participation duration varies based on individual treatment response and tolerability.
CONDITIONS
Brief Title
A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with CLDN6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer.
- Participants with measurable disease per RECIST 1.1.
- ECOG performance status of 0, 1, or 2 and life expectancy of at least 12 weeks.
- Participants with adequate organ function.
You will not qualify if you...
- Evidence of central nervous system metastases, leptomeningeal disease, or spinal cord compression.
- Uncontrolled significant active infection or any medical or other condition that would prevent participation.
- Concurrent participation in another investigational clinical trial.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive CTIM-76, a drug administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression, unacceptable toxicity, or participant/physician decision to stop.
Weekly visits for dosing each 28-day cycle
Trial Site Locations
Total: 13 locations
1
University of Arkansas Winthrop P. Rockefeller Cancer Institute
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
Precision NextGen Oncology & Research Center
Beverly Hills, California, United States, 90212
Withdrawn
3
SCRI at Denver Health
Denver, Colorado, United States, 80218
Actively Recruiting
4
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
Terminated
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
7
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Actively Recruiting
8
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Withdrawn
9
Providence Cancer Institute of Oregon
Portland, Oregon, United States, 97213
Actively Recruiting
10
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Withdrawn
11
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
Actively Recruiting
12
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
13
SCRI at Mary Crowley
Dallas, Texas, United States, 75230
Actively Recruiting
Research Team
C
Context Clinical Development
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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