NCT05173142

HMPL-453 (FGFR Inhibitor) in Combination With Chemotherapy or Anti-PD-1 Antibody in 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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 141 (estimated)
• Sponsor: Hutchison Medipharma Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ib/II clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of HMPL-453 combined with chemotherapy or anti-PD-1 antibody in patients with advanced solid tumors.

Detailed description

The study includes a dose escalation phase and a dose-expansion phase. Patients with advanced solid tumor will be enrolled in the dose escalation phase to assess the tolerability, safety, and PK profile of HMPL-453 monotherapy or combination therapy. Patients with specific types of advanced or metastatic tumors harboring certain FGFR gene alterations will be enrolled in the dose expansion phase to assess the preliminary efficacy of HMPL-453 combination therapy.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	HMPL-453	HMPL-453 administered orally.
DRUG	gemcitabine and cisplatin	Gemcitabine and Cisplatin administered intravenously.
DRUG	toripalimab	Toripalimab administered intravenously.
DRUG	Docetaxel	Docetaxel administered intravenously.

Timeline

• Start date: 2022-01-22
• Primary completion: 2024-09-01
• Completion: 2025-08-01
• First posted: 2021-12-29
• Last updated: 2022-03-08

Locations

1 site across 1 country: China