New drug combo shows promise for Hard-to-Treat cancers
NCT ID NCT05173142
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.
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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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A single arm, open label, dose-escalation phase i and dose-expansion phase IIa clinical study to evaluate the feasibility, safety, and efficacy of allogeneic chimeric antigen receptor (CAR) Gamma-Delta t cells CAR001 in subjects with Relapsed/Refractory solid tumors
- Can an antidepressant calm Chemotherapy's nerve pain?
- A new imaging agent aims to make solid tumors visible on PET scans
- Can a radioactive antibody seek out and destroy Hard-to-Treat tumors?
- Can a platform trial match the right drug combo to each tumor?
- Can immune cell infusions help fight solid tumors?