Endometrial Cancer, Platinum-resistant Ovarian Cancer, Testicular Cancer
Conditions
Brief 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).
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 according to the dose and schedule of the assigned cohort. Participants will be dosed until documentation of disease progression, unacceptable toxicity, or participant/physician decision. The phase 1b dose expansion phase will first evaluate CTIM-76 in PRROC at minimum, 2 dose levels and/or dosing schedules will be evaluated (n=20 response evaluable participants in each cohort) in the dose expansion phase of the trial. . 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.
Interventions
DRUGCTIM-76
CLDN6 bispecific Antibody administered weekly (Day 1, 8, 15 and 22) of a 28-day treatment cycle until disease progression.
Sponsors
Context Therapeutics Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase 1a is a dose escalation assessing 9 different dose levels and phase 1b will be evaluated in PRROC at a minimum of 2 dose levels and /or dosing schedules in the dose expansion phase of the trial (Phase 1b) to enable dose- and exposure-response analyses.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Dose Limiting Toxicities (DLTs) | From date of first dose of CTIM-76 until 28 days following the first dose | Phase 1a will evaluate increasing doses of CTIM-76 based on the assessment of DLTs |
| Overall response rate (ORR) | From date of first dose of CTIM-76 until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | ORR will be based on the best overall response rate as assessed by Investigators according to RECIST v1.1 |
Countries
United Kingdom, United States
Contacts
CONTACTContext Clinical Development
STUDY_CHAIRKaren Chagin, MD
Context Therapeutics Inc.
Outcome results
None listed