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Phase 1 Study of CTIM-76 for Recurring Ovarian and Other Advanced Solid Tumors

This study is testing a new drug called CTIM-76, a bispecific antibody, for people with platinum-resistant ovarian cancer, advanced testicular cancer, or advanced endometrial cancer. CTIM-76 works by directing your body's immune cells to fight cancer. To join, you must have cancer that has spread and can be measured, and your cancer must be positive for a specific marker called CLDN6. You also need to be generally well with good organ function. The main goals are to find a safe dose of CTIM-76 and see how well it shrinks tumors. The study plans to enroll 156 participants.

Study design
This is a Phase 1, open-label study that will enroll approximately 156 participants to test different doses of CTIM-76.
What's involved
You would receive CTIM-76 weekly (Day 1, 8, 15, and 22) in 28-day cycles until your disease gets worse or you experience unacceptable side effects.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be monitored until your disease progresses or you pass away, for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06515613

A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Context Therapeutics Inc.
~156 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:CTIM-76

At a glance

Recruiting sites
10 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Dose Limiting Toxicities (DLTs)
Measured over From date of first dose of CTIM-76 until 28 days following the first dose
+1 more outcome measured

Conditions

Platinum-resistant Ovarian Cancer
Testicular Cancer
Endometrial Cancer

Explore related trials

Endometrial CarcinomaMalignant Ovarian NeoplasmMalignant Testicular NeoplasmSolid NeoplasmCLDN6 Gene

Where it's being run

14 sites across 14 states
Arkansas1
California1
Colorado1
Massachusetts1
New Jersey1
New York1
North Carolina1
Ohio1

Study leadership

  • Karen Chagin, MD · STUDY_CHAIR · Context Therapeutics Inc.

Who to contact

Context Clinical Development
[email protected]
267-225-7416
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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