GFH276 with Cetuximab or chemotherapy in RAS-mutated solid tumors and PDAC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multicenter Phase Ib/II trial evaluating the safety, tolerability, and preliminary anti-tumor activity of oral GFH276 in combination with cetuximab or conventional chemotherapy in adults with locally advanced or metastatic solid tumors and PDAC with a RAS mutation. Participants are assigned to three treatment arms to explore different combination regimens. The Phase Ib portion uses dose escalation to identify a recommended Phase 2 dose based on safety, followed by Phase II expansion to assess efficacy and longer-term safety. Assessments include imaging, lab tests, adverse events, and pharmacokinetics throughout treatment until progression or other discontinuation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years
2. Histologically or cytologically confirmed locally advanced or metastatic solid tumor and PDAC with RAS mutation or KRAS amplification
3. At least one measurable lesion according to RECIST v1.1
4. ECOG performance status 0 or 1
5. Life expectancy \> 3 months
6. Adequate organ function
7. Willing to provide written informed consent
8. Fertile participants must use effective contraception

Exclusion Criteria:

1. Other active malignancy within 3 years
2. Symptomatic brain metastases, leptomeningeal disease, spinal cord compression, or primary brain tumor
3. History of active clinically significant cardiovascular dysfunction
4. For participants with known concomitant second oncodriver for PDAC or for solid tumors.
5. With active infection (HIV, HBV, HCV, syphilis)
6. The presence of clinical or radiological evidence of intestinal obstruction.
7. Prior anticancer therapy within 28 days or 5 half-lives
8. Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months
9. Hypersensitivity to study drugs, or inability to swallow tablets or comply with study procedures.
10. History of central nervous system (CNS)disease
11. Presence of clinically significant interstitial lung disease, radiation pneumonitis, or immune-related pneumonia that requires treatment.
12. With uncontrollable or symptomatic pleural effusion, ascites, or pericardial effusion.

Where it's running

• Macquarie University / Clinical Trials Unit
  North Ryde, New South Wales, Australia Recruiting
• Monash Health (Monash Medical Centre)
  Clayton, Victoria, Australia Recruiting
• PASO Medical
  Frankston, Victoria, Australia Recruiting
• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Bai Li
• Email: lbai@genfleet.com
• Phone: 18201333260

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.