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NOT YET RECRUITING
NCT07678593
PHASE1/PHASE2

A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation

Sponsor: Genfleet Therapeutics (Shanghai) Inc.

View on ClinicalTrials.gov

Summary

A Study of GFH276 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation

Official title: A Multi-center, Open-label Phase Ib/II Study Exploring the Safety/Tolerability, Pharmacokinetics, and Efficacy of GFH276 in Combination With Cetuximab or Chemotherapy in the Treatment of Patients With Advanced Solid Tumors and Pancreatic Ductal Adenocarcinoma (PDAC) Harboring RAS Mutation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

222

Start Date

2026-09

Completion Date

2028-09

Last Updated

2026-07-10

Healthy Volunteers

No

Interventions

DRUG

GFH276

Oral GFH276 administered once daily in combination with other study drugs.

DRUG

Cetuximab

Intravenous cetuximab at a dose of 500 mg/m²

DRUG

Nab paclitaxel

Intravenous nab-paclitaxel at a dose of 125 mg/m².

DRUG

Gemcitabine

Intravenous Gemcitabine at a dose of 1000 mg/m².

DRUG

Fluorouracil

Intravenous Fluorouracil at a dose of 2400 mg/m² via 46-hour infusion.Dosing may follow the above regimen or local institutional standards.

DRUG

Leucovorin

Intravenous leucovorin at a dose of 400 mg/m².Dosing may follow the above regimen or local institutional standards.

DRUG

Irinotecan

Intravenous irinotecan at a dose of 150 mg/m².Dosing may follow the above regimen or local institutional standards.

DRUG

Oxaliplatin

Intravenous oxaliplatin at a dose of 85 mg/m².Dosing may follow the above regimen or local institutional standards.

Locations (17)

Concord Cancer Centre, Concord Repatriation General Hospital, Sydney Local Health District

Concord, New South Wales, Australia

Macquarie University / Clinical Trials Unit

North Ryde, New South Wales, Australia

The Queen Elizabeth Hospital

Woodville South, South Australia, Australia

Monash Health (Monash Medical Centre)

Clayton, Victoria, Australia

Northern Health

Epping, Victoria, Australia

PASO Medical

Frankston, Victoria, Australia

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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

Guangzhou, Guangdong, China

The Third Affiliated Hospital (Cancer Hospital) of Harbin Medical University

Harbin, Heilongjiang, 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

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Shandong First Medical University Affiliated Tumor Hospital

Jinan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China