Evaluate the safety and tolerability of GH35 in patients with KRAS mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in patients with KRAS mutant advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
GH35 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F.
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Dose-limiting toxicities (DLT)
Number of participants with dose limiting toxicities (DLTs)
Time frame: 24 Days
Characterize the safety of GH35 in subjects
Number of participants with treatment-emergent adverse events
Time frame: 30 Months
Pharmacokinetics of GH35
Blood plasma concentration
Time frame: 1 Month
Objective response rate (ORR) as defined by RECIST 1.1 criteria
Time frame: 30 Months
Duration of response (DOR) as defined by RECIST 1.1 criteria
Time frame: 30 Months
Progression-free survival (PFS) as defined by RECIST 1.1 criteria
Time frame: 30 Months
Disease control rate (DCR) as defined by RECIST 1.1 criteria
Time frame: 30 Months
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