RecruitingPhase 1Phase 2NCT07259590

A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation

A Multicenter, Open-Label, Phase Ib/II Clinical Study to Explore the Efficacy, Pharmacokinetics and Safety/Tolerability of GFH375 in Combination With Cetuximab or Chemotherapy in Participants With Advanced Solid Tumors Harboring KRAS G12D Mutation


Sponsor

Genfleet Therapeutics (Shanghai) Inc.

Enrollment

126 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase Ib/II clinical study aimed at exploring the safety and efficacy of Regimen A (GFH375 in combination with Cetuximab) and Regimen B (GFH375 in combination with AG) in participants with solid tumors.Phase Ib: To evaluate the safety/tolerability and pharmacokinetic (PK) characteristics of GFH375 in combination with cetuximab or AG in participants with solid tumors, and to explore the efficacy of the combination therapy. Phase II: To evaluate the efficacy, safety/tolerability and PK characteristics of the combination therapy, and to explore the correlation between bio-marker and clinical efficacy.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing GFH375 — a new targeted drug — combined with either cetuximab (a targeted antibody) or chemotherapy, for people whose solid tumors carry a specific genetic mutation called KRAS G12D. **You may be eligible if...** - You are 18 or older (some treatment arms up to age 75) - You have confirmed advanced or metastatic solid tumor cancer with a KRAS G12D gene mutation - Your cancer has not responded to standard treatments, or you cannot tolerate them - You are in adequate physical health to receive treatment **You may NOT be eligible if...** - Your tumor does not have the KRAS G12D mutation - You have significant heart, liver, or kidney problems - You have active brain metastases that are unstable - You have had prior treatment that disqualifies participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

COMBINATION_PRODUCTGFH375

GFH375 once daily (QD) .Cetuximab will be administered via intravenous infusion at a dose of 500 mg/m² every 2 weeks.

COMBINATION_PRODUCTGFH375

GFH375 once daily (QD). Paclitaxel (albumin-bound) at 125 mg/m² and gemcitabine at 1000 mg/m² will be administered via intravenous infusion on Days 1, 8, and 15 of each 4-week cycle.


Locations(4)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07259590


Related Trials