Phase III Study to Compare GFH375 and Chemotherapy in Patients With KRAS G12D-Mutant Metastatic Pancreatic Cancer

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGenfleet Therapeutics (Shanghai) Inc.

About this trial

This study plans to enroll participants with previously treated metastatic pancreatic cancer and harbor centrally confirmed KRAS G12D mutation. These participants are required to experience disease progression on or after at least one prior standard systemic therapy containing fluorouracil or gemcitabine, and either progressed on or were intolerant to the last treatment. Eligible participants will be randomized 1:1 to the experimental group or the control group for treatment.

Eligibility criteria

Qualifiers

Voluntarily participate in the study and sign the informed consent form.

Male or female aged 18-80 years (inclusive) at the time of signing the informed consent form.

Pathologically confirmed pancreatic cancer (derived from pancreatic ductal epithelium) at metastatic stage.

Have received at least one prior standard systemic therapy.

Disqualifiers

Other malignant tumors that progressed or required treatment within 3 years prior to randomization.

With active central nervous system (CNS) metastasis.

Previous receipt of therapy targeted for KRAS G12D or pan-RAS/KRAS.

Received radiotherapy within 4 weeks prior to randomization or other local anti-tumor therapy within 4 weeks prior to randomization.

Trial design

Treatments tested in this trial

  • GFH375
  • Chemotherapy

Treatment groups

320 Participants
are divided into 2 treatment groups