This study is an investigation to evaluate the safety/tolerability, pharmacokinetics (PK), and efficacy of GFH276 as a single agent in patients with advanced solid tumors harboring RAS mutations. The primary objectives of the Phase I study are to assess the safety/tolerability, PK, and preliminary efficacy of GFH276 in patients with advanced solid tumors harboring RAS mutations, and to determine the Maximum Tolerated Dose (MTD) and Recommended Phase II Dose (RP2D) of GFH276. The primary objective of the Phase II study is to evaluate the efficacy of GFH276 in patients with RAS-mutant advanced pancreatic ductal adenocarcinoma (PDAC), advanced non-small cell lung cancer (NSCLC), advanced colorectal cancer (CRC), and other advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
450
GFH276 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
Sun-Yat sen university cancer center
Guangzhou, Guangdong, China
Phase Ia:The incidence and severity of AEs and SAEs
The incidence and severity of AEs and SAEs
Time frame: 48 months
Phase Ia:The incidence of DLT events
The incidence of DLT events
Time frame: 21 days
Phase Ib:The incidence and severity of AEs and SAEs
The incidence and severity of AEs and SAEs
Time frame: 48 months
Phase II:Overall response rate (ORR)
Aassessed by investigators according to RECIST 1.1
Time frame: about 48 months
Efficacy endpoints
Duration of response (DoR)
Time frame: about 48 months
Peak Plasma Concentration(Cmax)
Time frame: about 48 months
DCR
he percentage of patients who achieved CR, PR and SD
Time frame: about 48 months
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