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
Overview
- Phase
- Phase 1
- Intervention
- HMPL-453
- Conditions
- Solid Tumor
- Sponsor
- Hutchison Medipharma Limited
- Enrollment
- 141
- Locations
- 1
- Primary Endpoint
- Safety and tolerability(Incidence and severity of adverse events (AEs))
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
dose escalation phase of HMPL-453 monotherapy or combination therapy
HMPL-453 monotherapy or combination therapy
Intervention: HMPL-453
dose escalation phase of HMPL-453 monotherapy or combination therapy
HMPL-453 monotherapy or combination therapy
Intervention: gemcitabine and cisplatin
dose escalation phase of HMPL-453 monotherapy or combination therapy
HMPL-453 monotherapy or combination therapy
Intervention: toripalimab
indication specific dose expansion phase of HMPL-453 combination therapy
HMPL-453 combined with chemotherapy or anti-PD-1 antibody, in patients with IHCC, G/GEJ, or UC harboring specific FGFR gene alterations
Intervention: HMPL-453
indication specific dose expansion phase of HMPL-453 combination therapy
HMPL-453 combined with chemotherapy or anti-PD-1 antibody, in patients with IHCC, G/GEJ, or UC harboring specific FGFR gene alterations
Intervention: gemcitabine and cisplatin
indication specific dose expansion phase of HMPL-453 combination therapy
HMPL-453 combined with chemotherapy or anti-PD-1 antibody, in patients with IHCC, G/GEJ, or UC harboring specific FGFR gene alterations
Intervention: toripalimab
indication specific dose expansion phase of HMPL-453 combination therapy
HMPL-453 combined with chemotherapy or anti-PD-1 antibody, in patients with IHCC, G/GEJ, or UC harboring specific FGFR gene alterations
Intervention: Docetaxel
Outcomes
Primary Outcomes
Safety and tolerability(Incidence and severity of adverse events (AEs))
Time Frame: 6 months after the last patient enrolled
DLT, TEAEs and SAEs
Preliminary efficacy/Objective response rate (ORR)
Time Frame: up to 2 years
Objective response rate (ORR) in patients with the selected tumors along with certain FGFR gene alterations
Secondary Outcomes
- Efficacy/Progression-free survival (PFS)(up to 2 years)
- time to response (TTR)(up to 2 years)
- disease control rate (DCR)(up to 2 years)
- overall survival (OS)(up to 2 years)
- duration of response (DoR）(up to 2 years)