Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for Hard-to-Treat cancers? early trial of HMPL-A251 begins

NCT ID NCT07228247

Disease control Sponsor: Hutchmed 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This early-phase trial is testing an experimental drug called HMPL-A251 in adults with advanced or metastatic solid tumors that have high levels of a protein called HER2. The study aims to find a safe dose and see if the drug can shrink tumors. About 147 participants will receive the drug by IV infusion until their disease gets worse or side effects become too severe.

What this could mean

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

Active substance
HMPL-A251 (an experimental antibody drug given by IV infusion)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced HER2-positive solid tumors that have stopped responding to other therapies.
What could go wrong
This is a very early, first-in-human trial with only 147 participants. The drug may not shrink tumors or could cause serious side effects. Success in this small study does not guarantee it will work for everyone.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 147 people

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

Started

Dec 2025

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: 1. Histologically confirmed unresectable advanced or metastatic disease. 2. Have at least one measurable lesion per RECIST v1.1; 3. Life expectancy ≥ 12 weeks; 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1; 5. Weight ≥ 35 kg; Exclusion Criteria: 1. An established diagnosis of type I diabetes mellitus or uncontrolled type II diabetes mellitus. 2. Use of strong inhibitors of cytochrome P450 3A4 enzyme (CYP3A4), and inhibitors of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) within 5 elimination half-lives or 2 weeks (whichever is longer) before the first dose of study drug; 3. Toxicity from prior anti-tumor therapy has not recovered to Grade 1 or baseline prior to the first dose of study drug (except alopecia). Participants with chronic Grade 2 toxicities may be eligible after discussion between the investigator and Sponsor Medical Monitor (e.g., Grade 2 chemotherapy-induced neuropathy); 4. Baseline blood amylase or lipase exceeds the normal range and are judged by the investigators to be clinically significant; 5. Spinal cord compression, leptomeningeal disease, or clinically active central nervous system (CNS) metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms; 6. Major surgery within 28 days prior to the first dose of study drug. Participants must have recovered adequately from the toxicity and/or complications from the intervention prior to the first dose of study drug(s);

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Solid tumors, adult are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

cancer

As listed by the trial registrant

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

Solid tumors, adult

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

  • BRCR Global

    RECRUITING

    Plantation, Florida, 33322, United States

  • Cleveland Clinic Taussig Cancer Center

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Florida Clinical Trials Group LLC (Plantation)

    RECRUITING

    Plantation, Florida, 33322, United States

  • Florida Clinical Trials Group LLC (Tamarac)

    NOT_YET_RECRUITING

    Tamarac, Florida, 33321, United States

  • Fudan University Shanghai Cancer Center

    NOT_YET_RECRUITING

    Shanghai, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, China

  • Memorial Sloan Kettering Cancer Center

    NOT_YET_RECRUITING

    New York, New York, 10065, United States

  • Northwest Medical Specialties, PLLC

    NOT_YET_RECRUITING

    Tacoma, Washington, 98405, United States

  • Peking University First Hospital

    RECRUITING

    Beijing, China

  • SCRI HealthONE

    RECRUITING

    Denver, Colorado, 80218, United States

  • START New Jersey

    NOT_YET_RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, China

  • The First Hospital of China Medical University

    NOT_YET_RECRUITING

    Shenyang, China

More trials for these conditions

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