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.
Study ID
NCT07678593
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GFH276 — DRUG
    Oral GFH276 administered once daily in combination with other study drugs.
  • Cetuximab — DRUG
    Intravenous cetuximab at a dose of 500 mg/m²
  • Nab paclitaxel — DRUG
    Intravenous nab-paclitaxel at a dose of 125 mg/m².
  • Gemcitabine — DRUG
    Intravenous Gemcitabine at a dose of 1000 mg/m².
  • Fluorouracil — DRUG
    Intravenous Fluorouracil at a dose of 2400 mg/m² via 46-hour infusion.Dosing may follow the above regimen or local institutional standards.
  • Leucovorin — DRUG
    Intravenous leucovorin at a dose of 400 mg/m².Dosing may follow the above regimen or local institutional standards.
  • Irinotecan — DRUG
    Intravenous irinotecan at a dose of 150 mg/m².Dosing may follow the above regimen or local institutional standards.
  • Oxaliplatin — DRUG
    Intravenous oxaliplatin at a dose of 85 mg/m².Dosing may follow the above regimen or local institutional standards.

Study Details

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

Key Dates

First listed
Jul 1, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Nov 30, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
222 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: GFH276 + Cetuximab
    GFH276 once daily; cetuximab 500 mg/m² intravenous infusion every 2 weeks.
  • Experimental: Arm B: GFH276 + AG
    GFH276 once daily; nab-paclitaxel 125 mg/m² + gemcitabine 1000 mg/m² (AG regimen); 4-week cycle (D1, D8, D15) or 3-week cycle (D1, D8) in China
  • Experimental: Arm C: GFH276 + mFOLFIRINOX
    GFH276 once daily; mFOLFIRINOX :Fluorouracil 2400 mg/m²(46 h), Leucovorin 400 mg/m², Irinotecan 150 mg/m², Oxaliplatin 85 mg/m², IV D1, every 2 weeks . The mFOLFIRINOX regimen may be administered per the above dosage, or in accordance with national or institutional guidelines.

Primary Outcome Measure

Phase Ib:Incidence of Dose-Limiting Toxicity (DLT) Events [ Time Frame: First 28 days (21 days for AG （3-week cycle）) ]

Central Contacts

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