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A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study of GFH276 in Patients With RAS-Mutant Advanced Solid Tumors
Sponsor: Genfleet Therapeutics (Shanghai) Inc.
Summary
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.
Official title: A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2025-09-22
Completion Date
2027-12-30
Last Updated
2025-09-30
Healthy Volunteers
No
Conditions
Interventions
GFH276
GFH276 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.
Locations (1)
Sun-Yat sen university cancer center
Guangzhou, Guangdong, China