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
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
University of Arkansas Winthrop P. Rockefeller Cancer Institute
RECRUITING
Little Rock
California
Precision NextGen Oncology & Research Center
WITHDRAWN
Beverly Hills
Colorado
SCRI at Denver Health
RECRUITING
Denver
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
North Carolina
Duke Cancer Institute
RECRUITING
Durham
New Jersey
John Theurer Cancer Center
TERMINATED
Hackensack
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
Gabrail Cancer Center
WITHDRAWN
Canton
Oregon
Providence Cancer Institute of Oregon
RECRUITING
Portland
Pennsylvania
Fox Chase Cancer Center
WITHDRAWN
Philadelphia
Rhode Island
Women & Infants Hospital of Rhode Island
RECRUITING
Providence
Tennessee
Vanderbilt-Ingram Cancer Center
RECRUITING
Nashville
Texas
SCRI at Mary Crowley
RECRUITING
Dallas
Contact Information
Primary
MaryBeth LeRose
clinical@contexttherapeutics.com
267-225-7416
Time Frame
Start Date: 2024-07-10
Estimated Completion Date: 2028-04-30
Participants
Target number of participants: 80
Treatments
Experimental: CTIM-76
Phase 1a: Dose Escalation-each dose cohort will assess toxicity 28 days following the first dose of CTIM76; anticipate a total of 9 dose cohorts.~Phase 1b: Dose Expansion - 40 subjects will be evaluated using 2 different doses/dosing schedules of CTIM-76
Related Therapeutic Areas
Sponsors
Leads: Context Therapeutics Inc.