RecruitingPhase 2NCT07240766

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

Phase II Study of HRS-4642 in Combination With Nimotuzumab and Chemotherapy for Subjects With Borderline Resectable Pancreatic Cancer With KRAS G12D Mutation


Sponsor

Zhejiang University

Enrollment

40 participants

Start Date

Feb 15, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of a targeted drug (HRS-4642) aimed at a specific mutation called KRAS G12D — a common mutation in pancreatic cancer — together with an anti-cancer antibody (nimotuzumab) and chemotherapy, as a treatment before surgery for patients with borderline resectable (on the edge of being operable) pancreatic cancer. **You may be eligible if...** - You are 18 to 75 years old with pancreatic cancer confirmed by biopsy - Your cancer is borderline resectable (it might be operable with some shrinkage) - Your tumor has tested positive for the KRAS G12D mutation - You have not received any prior systemic cancer treatment - You are in good physical condition (ECOG score 0 or 1) with adequate organ function **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic) - Your cancer does not have a KRAS G12D mutation - You have already received chemotherapy or other systemic treatment - Your organ function does not meet study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHRS-4642+AG+Nimotuzumab

HRS-4642 Injection: 500 mg intravenous infusion on Day 1, and 1200 mg intravenous infusion on Day 8, every 3 weeks per cycle. A total of 4 cycles are planned in the neoadjuvant therapy phase, and up to a maximum of 4 cycles in the adjuvant therapy phase. Nimotuzumab: 400 mg on Days 1 and 8, every 3 weeks per cycle. A total of 4 cycles are planned in the neoadjuvant therapy phase, and up to a maximum of 4 cycles in the adjuvant therapy phase. Paclitaxel for Injection (Albumin-bound): 125 mg/m² on Days 1 and 8, every 3 weeks per cycle. A total of 4 cycles are planned in the neoadjuvant therapy phase, and up to a maximum of 4 cycles in the adjuvant therapy phase. Gemcitabine: 1000 mg/m² on Days 1 and 8, every 3 weeks per cycle. A total of 4 cycles are planned in the neoadjuvant therapy phase, and up to a maximum of 4 cycles in the adjuvant therapy phase. The recommended adjuvant treatment regimen is to continue HRS-4642 + Nimotuzumab + AG for 4 cycles.


Locations(2)

First Affiliated Hospital of Zhejiang University Schlool of Medicine

Hangzhou, Zhejiang, China

the First Affiliated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, China

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NCT07240766


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