NCT07232875

HRS 4642 Injection Combined With AG Versus Placebo Combined With AG Therapy in First-Line Advanced or Metastatic Pancreatic Cancer

a Randomized, Controlled, Double-Blind, Multicenter Phase III Clinical Trial of HRS-4642 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as First-Line Therapy in Patients With Advanced or Metastatic Pancreatic Carcinoma Harboring KRAS G12D Gene Mutation

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 588 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the first-line treatment of advanced pancreatic cancer with KRAS G12D mutation. Patients were randomized 1:1 to receive either the experimental regimen HRS-4642 plus AG or the control regimen AG alone.

Conditions

• KRAS G12D-Mutant Advanced or Metastatic Pancreatic Cancer in the First-line Setting

Interventions

Type	Name	Description
DRUG	HRS-4642 + AG	HRS-4642 + AG
DRUG	HRS-4642 placebo + AG	HRS-4642 placebo + AG

Timeline

• Start date: 2025-12-01
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2025-11-18
• Last updated: 2025-11-18

Locations

1 site across 1 country: China