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Monoclonal Antibodies

CTIM-76 for Ovarian Cancer

Phase 1

Recruiting

Research Sponsored by Context Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with CLDN6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer

ECOG 0, 1, or 2

Must not have

Evidence of central nervous system metastases, leptomeningeal disease or spinal cord compression

Prior treatment with CLDN-6 targeted therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called CTIM-76 in patients with ovarian cancer and other types of solid tumors that have not responded to platinum-based treatments. The study aims to determine the safety and

Who is the study for?

This trial is for individuals with recurring ovarian cancer or other advanced solid tumors that are resistant to platinum-based treatments. Participants must have a tumor that tests positive for CLDN6, which the study drug targets.

What is being tested?

The trial is testing CTIM-76, a new type of antibody designed to target and engage T cells against tumors. It's in early stages (Phase 1) where researchers are figuring out the right dose and checking how well it works on different cancers like ovarian, testicular, and endometrial.

What are the potential side effects?

As this is an early-stage trial for CTIM-76, specific side effects aren't listed yet but may include typical reactions to immune therapies such as fatigue, fever, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is CLDN6 positive and resistant to platinum-based treatments.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain or spinal cord.

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I have previously been treated with CLDN-6 targeted therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Dose Limiting Toxicities (DLTs)

Overall response rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CTIM-76Experimental Treatment1 Intervention

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

0 / 4Eligibility criteria met