NCT07198321

A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study of GFH276 in Patients With RAS-Mutant Advanced Solid Tumors

A Single-Arm, Open-Label, Multicenter Phase I/II Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Genfleet Therapeutics (Shanghai) Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• PDAC
• CRC (Colorectal Cancer)
• NSCLC

Interventions

Type	Name	Description
DRUG	GFH276	GFH276 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.

Timeline

• Start date: 2025-09-22
• Primary completion: 2027-09-22
• Completion: 2027-12-30
• First posted: 2025-09-30
• Last updated: 2025-09-30

Locations

1 site across 1 country: China