drugset / Trial / NCT07240766

HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation

NCT07240766

Phase 2 Recruiting 40 enrolled Zhejiang University
NaSingle-groupOpen-labelTreatment

Summary

This study is a Phase II clinical trial that plans to enroll 40 patients with borderline resectable pancreatic cancer harboring a KRAS G12D mutation, aiming to evaluate the efficacy of HRS-4642 in combination with Nimotuzumab and AG in borderline resectable pancreatic cancer. The study process includes a screening period (from the signing of the informed consent form until the first dose), a treatment period (from the first dose to the discontinuation of study treatment), and a follow-up period (safety follow-up and survival follow-up after the discontinuation of study treatment).

Timeline

Start
2026-02-15
Primary completion
2027-05-15
Completion
2028-11-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject HRS-4642 Unknown 500 mg Intravenous
Subject HRS-4642 Unknown 1200 mg Intravenous
Subject Nimotuzumab Monoclonal antibody 400 mg Intravenous
Subject Paclitaxel Small molecule 125 mg/m2 Intravenous

Indications