A Study of GFH375 Combined With Cetuximab or Chemotherapy in Participants With Solid Tumors Harboring KRAS G12D Mutation
Condition(s) studied
Investigational drug(s) / intervention(s)
GFH375: GFH375 once daily (QD) .Cetuximab will be administered via intravenous infusion at a dose of 500 mg/m² every 2 weeks.
GFH375: GFH375 once daily (QD). Paclitaxel (albumin-bound) at 125 mg/m² and gemcitabine at 1000 mg/m² will be administered via intravenous infusion on Days 1, 8, and 15 of each 4-week cycle.
Study summary
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.
Eligibility
Primary outcome measure(s)
- Phase Ib: Incidence of Dose-Limiting Toxicity (DLT) Events — up to 28 days
- Phase Ib: Incidence and Severity of Adverse Events (AE) and Serious Adverse Events (SAE) — From the first dose until 30 days after the last dose, assessed up to 24 months
- Phase II: Objective Response Rate (ORR) Evaluated by RECIST 1.1 — From the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | Recruiting |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | Not Yet Recruiting |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | Not Yet Recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | Not Yet Recruiting |
More Genfleet Therapeutics (Shanghai) Inc. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07259590 on ClinicalTrials.gov ↗ ← All trials in China