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New antibody takes aim at Hard-to-Treat cancers in first human trial

NCT ID NCT06515613

Disease control Sponsor: Context Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This early-stage trial is testing a new drug called CTIM-76 in people with advanced ovarian, testicular, or endometrial cancers that have not responded to standard treatments. CTIM-76 is a bispecific antibody designed to attach to a protein called Claudin-6 on cancer cells and help the body's immune T cells destroy them. The study will first find the safest dose, then check if the drug can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CTIM-76 (a bispecific antibody that targets Claudin-6 on cancer cells and engages T cells to attack them)
What this could lead to
If successful, this could point toward a new treatment option for people with certain advanced cancers that have stopped responding to standard therapy.
What could go wrong
This is a very early Phase 1 trial with only 156 participants, so the drug may not prove safe or effective. Side effects from T-cell engagement can be severe, and the cancer types studied are hard to treat.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 156 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrial carcinoma endometrium neoplasm malignant testicular germ cell tumor ovarian cancer ovarian carcinoma testicular cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Endometrial cancer Platinum-resistant ovarian cancer Testicular cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    11 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Institute

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Fox Chase Cancer Center

    WITHDRAWN

    Philadelphia, Pennsylvania, 19111, United States

  • Gabrail Cancer Center

    WITHDRAWN

    Canton, Ohio, 44718, United States

  • John Theurer Cancer Center

    TERMINATED

    Hackensack, New Jersey, 07601, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10021, United States

  • Precision NextGen Oncology & Research Center

    WITHDRAWN

    Beverly Hills, California, 90212, United States

  • Providence Cancer Institute of Oregon

    RECRUITING

    Portland, Oregon, 97213, United States

    Contact Email: •••••@•••••

  • SCRI at Denver Health

    RECRUITING

    Denver, Colorado, 80218, United States

  • SCRI at Mary Crowley

    RECRUITING

    Dallas, Texas, 75230, United States

  • University College London Hospital

    RECRUITING

    London, United Kingdom

  • University of Arkansas Winthrop P. Rockefeller Cancer Institute

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • University of Nebraska Medical

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • Vanderbilt-Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Women & Infants Hospital of Rhode Island

    RECRUITING

    Providence, Rhode Island, 02905, United States

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