A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorContext Therapeutics Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
CTIM-76
DrugCLDN6 bispecific Antibody administered weekly (Day 1, 8, 15 and 22) of a 28-day treatment cycle until disease progression.
Treatment groups
156 Participants
are divided into 1 treatment groupGroup A: CTIM-76Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Dose Limiting Toxicities (DLTs)
Phase 1a will evaluate increasing doses of CTIM-76 based on the assessment of DLTs
Time frame
From date of first dose of CTIM-76 until 28 days following the first dose2
Overall response rate (ORR)
ORR will be based on the best overall response rate as assessed by Investigators according to RECIST v1.1
Time frame
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov