A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
Purpose
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).
Conditions
- Platinum-resistant Ovarian Cancer
- Testicular Cancer
- Endometrial Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Phase 1a is a dose escalation assessing 9 different dose levels and phase 1b will evaluate 2 doses from the phase 1a.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Little Rock 4119403, Arkansas 4099753 72205
Denver 5419384, Colorado 5417618 80218
Hackensack 5098706, New Jersey 5101760 07601
New York 5128581, New York 5128638 10021
Portland 5746545, Oregon 5744337 97213
Philadelphia 4560349, Pennsylvania 6254927 19111
Providence 5224151, Rhode Island 5224323 02905
Nashville 4644585, Tennessee 4662168 37232
Dallas 4684888, Texas 4736286 75230
More Details
- NCT ID
- NCT06515613
- Status
- Recruiting
- Sponsor
- Context Therapeutics Inc.
Detailed Description
The phase 1a Dose Escalation portion of the trial will enroll participants with PRROC, testicular, or endometrial cancer into one of approximately 9 dose escalation cohorts to assess safety, tolerability and to determine the recommended dose for expansion (RDE). CTIM-76 is to be administered once weekly (Q1W) for each cycle. A cycle is defined as 28 days. Participants will be dosed until documentation of disease progression, unacceptable toxicity, or participant/physician decision. The phase 1b dose expansion phase will evaluate CTIM-76 in at least one indication at up to 2 doses and/or dosing schedules (n=20 response evaluable participants in each cohort ) in the dose expansion phase of the trial (Phase 1b) studying one of the following advanced solid tumor types: PROC, testicular, or endometrial. This is to enable dose- and exposure-response analyses. The expansion doses/dosing schedules for Phase 1b will be determined by Sponsor in conjunction with Safety Review Committee (SRC) based upon all available safety, pharmacokinetic (PK), pharmacodynamic (PD), biomarker and preliminary efficacy data from Phase 1a. The selection of the RP2D will be based on the totality of data from Phase 1b.