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 (10) 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 humanized T cell engaging bispecific antibody targeting CLDN6, in subjects 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:
• Subjects with CLDN6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer.
• Subject with measurable disease per RECIST 1.1
• ECOG 0, 1, or 2
• Subjects with adequate organ function.
Locations
United States
Arkansas
Context Investigational Site
RECRUITING
Little Rock
California
Context Investigational Site
WITHDRAWN
Beverly Hills
Colorado
Context Investigational Site
RECRUITING
Denver
New Jersey
Context Investigational Site
RECRUITING
Hackensack
New York
Context Investigational Site
RECRUITING
New York
Ohio
Context Investigational Site
WITHDRAWN
Canton
Oregon
Context Investigational Site
RECRUITING
Portland
Pennsylvania
Context Investigational Site
RECRUITING
Philadelphia
Rhode Island
Context Investigational Site
RECRUITING
Providence
Texas
Context Investigational Site
RECRUITING
Dallas
Contact Information
Primary
MaryBeth LeRose
clinical@contexttherapeutics.com
267-225-7416
Time Frame
Start Date: 2024-07-10
Estimated Completion Date: 2028-03-31
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 - 30 subjects will be evaluated using 2 different doses of CTIM-76
Related Therapeutic Areas
Sponsors
Leads: Context Therapeutics Inc.