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

Not Applicable

Not yet recruiting

• Conditions: Cancer; PDAC; CRC (Colorectal Cancer); NSCLC
• Interventions: Drug: GFH276

• Registration Number: NCT07198321
• Lead Sponsor: Genfleet Therapeutics (Shanghai) Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-15
• Study Start: 2025-09-22
• Study First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study First Posted: 2025-09-30
• Last Update Posted: 2025-09-30
• Primary Completion: 2027-09-22
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
2. Male or female ≥ 18 years old and ≤75 years old.
3. ECOG performance status of 0-1.
4. With a life expectancy of ≥3 moths
5. Have at least one measurable lesion according to RECIST1.1, and the phase Ia allows no measurable lesion.
6. Adequate laboratory parameters during the screening period.

Exclusion Criteria

1. Active brain metastases.
2. Prior treatment with a PAN-RAS inhibitor.
3. Palliative radiotherapy was completed within 14 days before the first dose.
4. Have poorly controlled or severe cardiovascular disease.
5. Subjects with active hepatitis B or active hepatitis C.
6. Known allergy to the study drug or its components.
7. Pregnant or lactating women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GFH276	GFH276	GFH276 will be administered at the assigned dose level, orally, until disease progression or intolerable toxicity.

Primary Outcome Measures

Name	Time	Method
Phase Ia:The incidence and severity of AEs and SAEs	48 months	The incidence and severity of AEs and SAEs
Phase Ia:The incidence of DLT events	21 days	The incidence of DLT events
Phase Ib:The incidence and severity of AEs and SAEs	48 months	The incidence and severity of AEs and SAEs
Phase II:Overall response rate (ORR)	about 48 months	Aassessed by investigators according to RECIST 1.1
Efficacy endpoints	about 48 months	Duration of response (DoR)

Secondary Outcome Measures

Name	Time	Method
Peak Plasma Concentration(Cmax)	about 48 months
DCR	about 48 months	he percentage of patients who achieved CR, PR and SD

Trial Locations

Locations (1)

Sun-Yat sen university cancer center; 🇨🇳 Guangzhou, Guangdong, China