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

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• Colorectal Neoplasms 5,590

Keywords

• solid tumors
• KRAS G12D Mutations

Study arms

• Experimental
  Arm A：GFH375 in combination with Cetuximab

  Arm A will enroll participants with locally advanced or metastatic solid tumors with KRAS G12D mutation.

  Combination Product: GFH375

• Experimental
  Arm B：GFH375 in combination with AG

  Arm B will enroll participants with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) with KRAS G12D mutation.

  Combination Product: GFH375

Interventions

• Combination productGFH375

  GFH375 once daily (QD) .Cetuximab will be administered via intravenous infusion at a dose of 500 mg/m² every 2 weeks.

  Also known as: Cetuximab

• Combination productGFH375

  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.

  Also known as: Paclitaxel (albumin-bound), gemcitabine

Primary outcomes

1. Phase Ib: Incidence of Dose-Limiting Toxicity (DLT) Events

   Time frame: up to 28 days

2. Phase Ib: Incidence and Severity of Adverse Events (AE) and Serious Adverse Events (SAE)

   Time frame: From the first dose until 30 days after the last dose, assessed up to 24 months

3. Phase II: Objective Response Rate (ORR) Evaluated by RECIST 1.1

   Time frame: 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

Secondary outcomes

1. Plasma concentrations of GFH375

   Plasma concentrations of GFH375

   Time frame: up to 6 months

2. Phase II: Incidence and Severity of AE and SAE

   Time frame: From the first dose until 30 days after the last dose, assessed up to 24 months

3. DCR

   DCR assessed by investigators

   Time frame: 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

4. TTR

   TTR assessed by investigators

   Time frame: 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

5. DOR

   DoR assessed by investigators

   Time frame: 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

6. PFS

   Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, as Determined by investagors

   Time frame: 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

7. OS

   Overall Survival

   Time frame: From the first dose until date of death from any cause, assessed up to 24 months

Individual participant data

Plan to share: No