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New immune drug targets common cancer mutation in early trial

NCT ID NCT06778863

Disease control Sponsor: Clasp 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial is testing a new drug called CLSP-1025 in about 90 adults with advanced solid tumors (like lung, colon, or breast cancer) that have a specific p53 mutation (R175H). The drug works by directing the body's immune cells to attack cancer cells carrying this mutation. The study aims to find the safest dose and see 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
CLSP-1025 (a drug that helps immune cells attack cancer cells with a specific p53 mutation)
What this could lead to
If successful, this could point toward a new treatment option for several hard-to-treat cancers that have a specific p53 mutation.
What could go wrong
This is an early Phase 1 trial with only 90 participants, so safety and effectiveness are not yet proven. The drug may cause side effects or fail to shrink tumors.

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 90 people

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

Started

Feb 2025

Expected to finish

Jun 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.

Key Inclusion Criteria: * Patients must be at least 18 years of age at the time of signing the informed consent. * Patients must be willing and able to provide written informed consent * Patients must have locally advanced or metastatic solid tumors that have progressed after standard of care therapy or for which no standard therapy exists * Tumors must harbor a TP53 R175H variant mutation confirmed by an accredited laboratory-based test * Patients must be HLA-A\*02:01 positive by central assay * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at the time of enrollment * Adequate hematological, renal and hepatic function * Per Investigator judgement, patient is willing and able to complete study visits and/or procedures per the protocol and comply with study requirements for study participation Key Exclusion Criteria: * Patients with Li-Fraumeni syndrome or other known germline p53 R175H mutation * Patients who have received other p53 R175H-directed therapies * Patients who have not fully recovered from adverse events due to previous anticancer therapies * Patients with active infection requiring systemic antimicrobial therapy * Any other primary malignancy within the 2 years prior to enrollment (except for non- melanoma skin cancer, carcinoma in situ (eg, cervix, bladder, breast) or prostate cancer in remission. * Known active central nervous system metastases and/or carcinomatous meningitis

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm colorectal adenocarcinoma head and neck squamous cell carcinoma lung cancer lung neoplasm metastatic malignant neoplasm Neoplasm Metastasis ovarian cancer pancreatic adenocarcinoma prostate cancer Squamous Cell Carcinoma of Head and Neck urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

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

Advanced solid tumor Bladder cancer Breast cancer Colorectal adenocarcinoma Head and neck squamous cell carcinoma Lung cancer Metastatic solid tumor Ovarian cancer Pancreatic adenocarcinoma Prostate cancer Unresectable solid tumor

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

    21 sites. 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

  • Baylor University Medical Center

    RECRUITING

    Dallas, Texas, 75246, United States

  • Duke Cancer Institute

    RECRUITING

    Durham, North Carolina, 27701, United States

  • Fox Chase Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • HonorHealth Research Institute

    RECRUITING

    Scottsdale, Arizona, 85258, United States

  • Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Mary Crowley Cancer Research

    RECRUITING

    Dallas, Texas, 75230, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

  • Sarah Cannon Research Institute (SCRI) Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • The University of Arizona Cancer Center

    RECRUITING

    Tucson, Arizona, 85719, United States

  • The University of Chicago Comprehensive Cancer Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Thomas Jefferson University, Sidney Kimmel Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • USC - Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

    Contact Email: •••••@•••••

  • University of California Davis Comprehensive Cancer Center

    RECRUITING

    Sacramento, California, 95817, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Kentucky Markey Cancer Center

    RECRUITING

    Lexington, Kentucky, 40536, United States

  • University of Miami - Sylvester Comprehensive Cancer Center

    RECRUITING

    Miami, Florida, 33136, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.