A Phase Ib/II Clinical Study Evaluating HMPL-453 Tartrate as Monotherapy and in Combination with Chemotherapy or Toripalimab in Advanced Solid Tumors
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 monotherapy or combination therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
190
HMPL-453 administered orally.
Gemcitabine and Cisplatin administered intravenously.
Toripalimab administered intravenously.
Chinese PLA General Hospital
Beijing, China
Safety and tolerability(Incidence and severity of adverse events (AEs))
DLT, TEAEs and SAEs
Time frame: 6 months after the last patient enrolled
Preliminary efficacy/Objective response rate (ORR)
Objective response rate (ORR) in patients with the selected tumors along with certain FGFR gene alterations
Time frame: up to 2 years
Efficacy/Progression-free survival (PFS)
the duration between the enrollment date and the first disease progression (PD) or death (whichever comes first).
Time frame: up to 2 years
disease control rate (DCR)
The incidence of complete response, partial response and stable disease
Time frame: up to 2 years
time to response (TTR)
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).
Time frame: up to 2 years
duration of response (DoR)
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
Time frame: up to 2 years
overall survival (OS)
The period from date of enrollment to date of death
Time frame: up to 2 years
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Docetaxel administered intravenously.