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Experimental IDH drug trial halted early

NCT ID NCT04762602

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 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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-stage study tested a new drug, HMPL-306, in 42 adults with advanced solid tumors that have an IDH mutation. The goal was to find a safe dose and check for side effects. The study was terminated early, so results are limited and no cure is expected.

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

42 people

The number who actually took part.

Started

Feb 2021

Finished

Feb 2025

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: Subjects are eligible for enrollment into this study if they meet any of the following criteria (NOTE: This is not an exhaustive list): * Subjects aged ≥18 years. * ECOG performance status 0 or 1 * Subjects must have a documented IDH mutation per immunohistochemistry (IHC), polymerase chain reaction (PCR), or next generation sequencing (NGS) testing of tumor tissue. * Subjects must have histologically or cytologically documented, advanced or metastatic solid malignancy of any type that has recurred or progressed on available standard treatment and for which no curative therapy exists. Key Exclusion Criteria: Subjects are not eligible for enrollment into this study if they meet any of the following criteria (NOTE: This is not an exhaustive list): * Subjects who received an investigational agent \<14 days prior to their first day of study drug administration * Subjects who are pregnant or breastfeeding * Subjects with an active severe infection, some treated infections and with an expected or with an unexplained fever \>38.3°C during screening visits or on their first day of study drug administration. * Subjects with some current or prior heart conditions * Subjects taking medications that are known to prolong the QT interval may not be eligible * Subjects with immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation * Some subjects with some current or prior gastrointestinal or liver diseases * Subjects with inadequate organ function as defined by the protocol

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Conditions

The condition(s) this trial relates to.

cholangiocarcinoma glioma

As listed by the trial registrant

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

Isocitrate dehydrogenase gene mutation

Contacts and locations

Locations

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital de la Santa creu i Sant Pau

    Barcelona, 08025, Spain

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Sarcoma Oncology Research Center

    Santa Monica, California, 90403, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UPMC Hillman Cancer

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

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