Combining HMPL-453 with chemotherapy or anti-PD-1 antibody for advanced solid tumors

A Phase Ib/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HMPL-453 (FGFR Inhibitor) Combined With Chemotherapy or Anti-PD-1 Antibody in Patients With Advanced Solid Tumors

This study is testing if a new drug called HMPL-453, when combined with chemotherapy or an anti-PD-1 antibody, can help people with advanced solid tumors feel better and improve their treatment outcomes.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 141 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hutchmed (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT05173142 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of HMPL-453, an FGFR inhibitor, in combination with chemotherapy or an anti-PD-1 antibody for patients with advanced solid tumors. The study consists of a dose escalation phase to assess tolerability and pharmacokinetics, followed by a dose expansion phase targeting specific tumor types with FGFR gene alterations. Patients will be monitored for safety and preliminary efficacy outcomes throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with advanced solid tumors who have progressed on or are intolerant to standard therapies.

Not a fit: Patients who have previously received selective FGFR targeting therapy or are currently participating in another interventional clinical study may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that have specific genetic alterations.

How similar studies have performed: Other studies have shown promise with FGFR inhibitors in similar contexts, suggesting potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Beijing

• Chinese PLA General Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Min Ling, Bachelor

Conditions Solid Tumor; HMPL-453, FGFR, PD-1,IHCC, ICC, gastric cancer