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

NCT ID: NCT07198321

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-22
• Study Completion Date: 2027-12-30

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.

Conditions

Cancer; PDAC; CRC (Colorectal Cancer); NSCLC

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GFH276

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

Group Type: EXPERIMENTAL

GFH276

Intervention Type: DRUG

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

Interventions

GFH276

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genfleet Therapeutics (Shanghai) Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

li zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun-Yat sen university cancer center

Guangzhou, Guangdong, China

Countries

China

Central Contacts

peng, PM

Role: CONTACT

ytpeng@genfleet.com

021-50781198

Facility Contacts

li zhang, MD

Role: primary

zhangli@syscc.org.cn

020-87343533

Other Identifiers

GFH276X1101

Identifier Type: -

Identifier Source: org_study_id