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

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumors Cancer, PDAC, CRC (Colorectal Cancer)

In brief

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.

Key facts

Study ID

NCT07259590

Run by

Genfleet Therapeutics (Shanghai) Inc.

People needed

126

Starts

2025-10-21

Expected to finish

2027-07-01

Last updated by the study team

2025-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Voluntarily participate in the study and sign the informed consent form.
• Participants receiving Regimen A must be ≥ 18 years old when signing the informed consent form, and participants receiving Arm B must be 18 - 75 years old.
• Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumors, with KRAS G12D mutation.
• Failed standard systemic treatment, or intolerant to standard treatment, or unsuitable for standard treatment, or no standard treatment available.
• At least one measurable lesions according to RECIST v1.1
• Participants receiving Regimen A must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 - 2; participants receiving Regimen B must have an ECOG PS score of 0 - 1.
• Have sufficient organ function.

You may not qualify if…

• Symptomatic brain metastasis, leptomeningeal metastasis, spinal cord compression, or primary brain tumor.
• Presence of known coexisting other cancer driver genes.
• Previous or active history of clinically significant cardiovascular dysfunction.
• Presence of active infection.
• History of central nervous system (CNS) diseases.
• Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonitis requiring treatment.
• Newly diagnosed deep vein thrombosis or pulmonary embolism within 3 months before the first administration of the study treatment.
• Presence of uncontrolled or symptomatic pleural effusion, ascites, or pericardial effusion.
• Having received major surgery within 28 days before the start of the study treatment; having experienced major trauma within 14 days before the start of the study treatment; or planning to undergo major surgery during the study period.
• Having received radiotherapy within 4 weeks before the start of the study treatment, or having received palliative radiotherapy for bone metastatic lesions within 2 weeks before the start of the study treatment.

Where it is running

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
• 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

Full record on ClinicalTrials.gov

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