RecruitingPhase 2NCT07438106

A Phase II Study of HRS-4642 Combined With AG (Nab-paclitaxel and Gemcitabine) as Conversion Therapy for Locally Advanced Pancreatic Cancer


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

30 participants

Start Date

Jan 28, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate the effectiveness and safety of HRS-4642 in combination with nab-paclitaxel and gemcitabine (AG regimen) as conversion therapy for patients with locally advanced pancreatic cancer. Participants will undergo regular assessments, including imaging scans and CA19-9 biomarker tests. If disease recurrence is suspected, unscheduled evaluations may be performed. For participants who discontinue treatment due to reasons other than disease progression (e.g., toxicity), tumor assessments will continue as scheduled until progression, loss to follow-up, death, consent withdrawal, or study termination. After the final treatment, participants will enter a survival follow-up phase. Investigators will contact the participants or their families approximately every month (±7 days) to collect information on survival status (date and cause of death) and any subsequent anti-cancer treatments until death, loss to follow-up, study termination, or other study endpoints are met. All follow-up information will be documented in the medical records.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called HRS-4642 combined with standard chemotherapy (nab-paclitaxel and gemcitabine) to shrink locally advanced pancreatic cancer enough that surgery becomes possible. The cancer must have a specific genetic mutation called KRAS G12D for patients to qualify. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with locally advanced pancreatic cancer (not spread to other organs) confirmed by biopsy - Your tumor has the KRAS G12D mutation - You have not had any prior treatment for pancreatic cancer - You are generally in good physical health (able to carry out daily activities) - Your blood counts, liver, and kidney function are within acceptable levels **You may NOT be eligible if...** - Your cancer has spread to other parts of the body - You have had another cancer in the last 5 years (minor skin cancers may be okay) - You have an active autoimmune disease requiring ongoing treatment - You have had a heart attack, stroke, or serious heart condition in the last 6 months - You have poorly controlled blood pressure, active tuberculosis, or active hepatitis B or C - 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 Injection

Investigational Product: HRS-4642 Injection. Dosage Form: Injection. Strength: 10 mL: 30 mg. Route of Administration: Intravenous Infusion. Manufacturer: Jiangsu Hengrui Pharmaceuticals Co., Ltd. Background: HRS-4642 is a highly potent, long-lasting, and selective KRAS G12D inhibitor developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui). It is a liposomal formulation. HRS-4642 specifically binds to KRAS G12D, thereby inhibiting the phosphorylation of MEK and ERK proteins, and exerts an antitumor effect.


Locations(1)

Jiangsu Province Hospital

Nanjing, China

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NCT07438106