RecruitingPhase 2NCT06770452

HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients

A Single-arm Phase II Study of HRS-4642 With Nimotuzumab and Chemotherapy for First-line Treatment of Advanced Pancreatic Cancer Patients With KRAS G12D Mutations


Sponsor

Zhejiang University

Enrollment

32 participants

Start Date

Mar 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-arm phase II clinical study to include 32 patients with advanced pancreatic cancer with KRAS G12D mutation to evaluate the effectiveness of HRS-4642 combined with nitutuzumab and AG for first-line treatment of advanced pancreatic cancer.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of HRS-4642, nimotuzumab (an antibody), and chemotherapy as a first-line treatment for people with advanced pancreatic cancer whose tumors have a specific genetic mutation called KRAS G12D — one of the most common mutations in pancreatic cancer. **You may be eligible if...** - You are 18–75 years old with metastatic pancreatic cancer - Your tumor has been confirmed to have the KRAS G12D mutation - You have not received systemic treatment for advanced disease (prior surgery-related treatment ended more than 6 months ago is acceptable) - You have at least one measurable tumor on imaging - Your general health is adequate (ECOG 0-1) **You may NOT be eligible if...** - You have previously received drugs targeting KRAS G12D or EGFR - You had major surgery within the past 4 weeks - You have brain metastases - You have severe heart, liver, or kidney problems - You are pregnant or breastfeeding 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

HRS-4642 is a KRAS G12D inhibitor

DRUGNimotuzumab

Nimotuzumab is a humanized IgG 1 monoclonal antibody targeting EGFR

DRUGgemcitabine + nab-paclitaxel

Albumin paclitaxel 125mg/m2 intravenous infusion, gemcitabine 1000mg / m2, D1,8, a cycle every 3 weeks


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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NCT06770452


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