drugset / Trial / NCT07240766
HRS-4642 in Combination With Nimotuzumab and Chemotherapy for BRPC With KRAS G12D Mutation
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |