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New immune drug PHST001 enters first human trials for Hard-to-Treat cancers

NCT ID NCT06840886

Disease control Sponsor: Pheast Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times

Summary

This early-phase trial is testing a new drug called PHST001, which helps the immune system attack cancer cells by blocking a protein called CD24. The study will first test PHST001 alone, then in combination with standard chemotherapy, in adults with advanced solid tumors (including ovarian, endometrial, and bile duct cancers) that have not responded to other treatments. The main goals are to check safety and find the best dose.

What this could mean

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

Active substance
PHST001 (an experimental immune therapy that targets CD24 on cancer cells)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is a very early (Phase 1) trial, so the main goal is safety, not effectiveness. It may not shrink tumors or improve survival, and there could be unexpected side effects.

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 272 people

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

Started

Mar 2025

Expected to finish

Apr 2031

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: * Histologically or cytologically confirmed advanced solid tumor which has relapsed from or been refractory to all locally available standard therapies. * Adequate organ function per laboratory testing * Pregnancy prevention requirements * Measurable disease per RECIST v1.1 (or RANO) as assessed by the local site Investigator/radiology * Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale Key Exclusion Criteria: * Diagnosis of immunodeficiency * History of a previous additional malignancy, unless potentially curative treatment has been completed, with no evidence of malignancy for 5 years. Participants with basal cell carcinoma of the skin, Stage I melanoma, melanoma in situ, squamous cell carcinoma of the skin, early-stage prostate cancer, or carcinoma in situ, excluding carcinoma in situ of the bladder, who have undergone potentially curative therapy are not excluded and can be enrolled regardless of disease-free period following completion of potentially curative therapy. Participants with early-stage breast cancer who have undergone curative intent treatment and with no disease recurrence for 2 years after treatment are not excluded. * Active known CNS metastases and/or carcinomatous meningitis. Participants with previously treated CNS metastases may participate provided they are radiologically stable (i.e., without evidence of progression for at least 2 weeks by repeat imaging \[note that the repeat imaging should be performed during study screening\]), clinically stable, and without requirement of steroid treatment for at least 14 days prior to the first dose of study treatment. * Received prior systemic anticancer therapy including investigational agents within 21 days or, if shorter, within 5 half-lives prior to the first dose of study treatment. Participants must have recovered from all AEs due to previous therapies to Grade ≤1 or baseline. Participants with Grade ≤2 neuropathy may be eligible. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible. * Prior autologous or allogeneic hematopoietic stem cell transplant or solid organ transplant. * Received previous treatment with another agent targeting CD24.

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Conditions

The condition(s) this trial relates to.

central nervous system cancer central nervous system neoplasm cholangiocarcinoma endometrial cancer endometrium neoplasm neoplasm ovarian cancer

As listed by the trial registrant

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

Advanced solid tumors Cholangiocarcinoma CNS tumor Endometrial cancer Ovarian 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

    20 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Institute

    RECRUITING

    Durham, North Carolina, 27710, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • NEXT Oncology - Dallas

    RECRUITING

    Irving, Texas, 75039, United States

  • NEXT Oncology - Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Precision NextGen Oncology & Research Center

    RECRUITING

    Beverly Hills, California, 90212, United States

  • START Center for Cancer Research - Long Island New York

    RECRUITING

    Lake Success, New York, 11042, United States

  • START Center for Cancer Research - Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START Center for Cancer Research - San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • START Center for Cancer Research - Texas

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • Sarah Cannon Research Institute (SCRI) Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute (SCRI) Oncology Partners - Denver Health One

    RECRUITING

    Denver, Colorado, 80218, United States

  • Stanford University School of Medicine

    RECRUITING

    Palo Alto, California, 94304, United States

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Michigan Rogel Cancer Center

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • University of Texas (UT) Health

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Vanderbilt-Ingram Cancer Center

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06520, United States

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