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

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 cli

Trial Details

NCT ID
NCT07259590
Phase
PHASE1 / PHASE2
Sponsor
Genfleet Therapeutics (Shanghai) Inc.
Status
RECRUITING
Cancer Type
Colon Cancer Colorectal Cancer
Interventions
  • GFH375
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Zhengzhou, Henan, China|34.75778,113.64861
  • Wuhan, Hubei, China|30.58333,114.26667

Key Eligibility Criteria

  • 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 ye…
  • 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.

For full eligibility, visit ClinicalTrials.gov.

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