New drug combo shows promise for Hard-to-Treat cancers

NCT ID NCT05173142

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a new oral drug called HMPL-453 tartrate, either alone or combined with chemotherapy or an immunotherapy (toripalimab), in 190 people with advanced solid tumors that had stopped responding to standard treatments. The main goals were to check safety and see if the drug shrinks tumors, especially in cancers with certain FGFR gene changes. The trial is complete, but results are not yet reported.

What this could mean

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

Active substance
HMPL-453 tartrate (oral drug) given alone or with chemotherapy (gemcitabine, cisplatin, docetaxel) or toripalimab (immunotherapy)
What this could lead to
If successful, this could point toward a new treatment option for advanced solid tumors with specific genetic changes.
What could go wrong
This is an early-phase trial (phase 1/2) with a small number of participants, so results may not lead to a proven therapy. Side effects from the drug combinations are possible.

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

190 people

The number who actually took part.

Started

Jan 2022

Finished

Jan 2026

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 to 75 years

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 * Dose escalation phase: patients with histologically or cytologically confirmed locally advanced or metastatic solid tumor who progressed on or are intolerant of standard therapy; * Dose expansion phase: patients with UC, GC/GEJ, or IHCC harboring specific FGFR gene alterations; * Age 18 to 75 years; * Those who are able to give written informed consent, and able to comply with protocol-specified visits and related procedures; * Ability to swallow study drug; * ECOG PS of 0 or 1; * Measurable lesion according to RECIST v1.1, refer to the protocol; * Adequate organ and bone marrow function; * Life expectancy ≥ 12 weeks; * Female patients or male patients with partners of childbearing potential must take effective contraceptive measures per the protocol. Exclusion Criteria * Patients who previously received selective FGFR targeting therapy; * Concurrent participation in another interventional clinical study, excluding those in the follow-up period and have not recently received investigational intervention; * Current or previous history of central nervous system (CNS) metastases; * Current or previous history of retinal detachment; * Known history of primary immunodeficiency; * Female patients who are pregnant or lactating; * Patients who in the opinion of the investigator may be unsuitable for participating in the study; * Patients with acute or chronic active hepatitis B or C infection; * Known human immunodeficiency virus (HIV) infection and syphilis infection; * Clinically significant cardiovascular disease such as congestive heart failure or arrhythmia; * Uncontrolled hypertension despite optimal medical management; * Received live vaccine within 30 days before the first dose of study drug(s); * Those who have undergone major surgical procedures (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to the first study treatment or who are expected to be in need of major surgery; those with unhealed wounds, ulcers or fractures.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Chinese PLA General Hospital

    Beijing, China

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