HMPL-453 (FGFR Inhibitor) in Combination With Chemotherapy or Anti-PD-1 Antibody in Advanced Solid Tumors
- Conditions
- Solid Tumor
- Interventions
- Registration Number
- NCT05173142
- Lead Sponsor
- Hutchison Medipharma Limited
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 141
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description indication specific dose expansion phase of HMPL-453 combination therapy gemcitabine and cisplatin HMPL-453 combined with chemotherapy or anti-PD-1 antibody, in patients with IHCC, G/GEJ, or UC harboring specific FGFR gene alterations dose escalation phase of HMPL-453 monotherapy or combination therapy gemcitabine and cisplatin HMPL-453 monotherapy or combination therapy indication specific dose expansion phase of HMPL-453 combination therapy HMPL-453 HMPL-453 combined with chemotherapy or anti-PD-1 antibody, in patients with IHCC, G/GEJ, or UC harboring specific FGFR gene alterations dose escalation phase of HMPL-453 monotherapy or combination therapy HMPL-453 HMPL-453 monotherapy or combination therapy dose escalation phase of HMPL-453 monotherapy or combination therapy toripalimab HMPL-453 monotherapy or combination therapy indication specific dose expansion phase of HMPL-453 combination therapy toripalimab HMPL-453 combined with chemotherapy or anti-PD-1 antibody, in patients with IHCC, G/GEJ, or UC harboring specific FGFR gene alterations indication specific dose expansion phase of HMPL-453 combination therapy Docetaxel HMPL-453 combined with chemotherapy or anti-PD-1 antibody, in patients with IHCC, G/GEJ, or UC harboring specific FGFR gene alterations
- Primary Outcome Measures
Name Time Method Safety and tolerability(Incidence and severity of adverse events (AEs)) 6 months after the last patient enrolled DLT, TEAEs and SAEs
Preliminary efficacy/Objective response rate (ORR) up to 2 years Objective response rate (ORR) in patients with the selected tumors along with certain FGFR gene alterations
- Secondary Outcome Measures
Name Time Method Efficacy/Progression-free survival (PFS) up to 2 years the duration between the enrollment date and the first disease progression (PD) or death (whichever comes first).
time to response (TTR) up to 2 years The period from the date of enrollment to the date when the criteria for complete response or partial response was first measured (first record shall prevail).
disease control rate (DCR) up to 2 years The incidence of complete response, partial response and stable disease
overall survival (OS) up to 2 years The period from date of enrollment to date of death
duration of response (DoR） up to 2 years The duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recorded
Trial Locations
- Locations (1)
Chinese PLA General Hospital
🇨🇳Beijing, China