NCT07438106

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study Objectives Primary Objective: ● To evaluate the efficacy of HRS-4642 combined with AG (nab-paclitaxel and gemcitabine) as conversion therapy in patients with locally advanced pancreatic cancer, as measured by Objective Response Rate (ORR). Secondary Objectives: * To evaluate the efficacy of HRS-4642 combined with AG as conversion therapy by assessing surgical conversion rate, Disease Control Rate (DCR), CA19-9 response rate, Duration of Response (DOR), Progression-Free Survival (PFS), Overall Survival (OS), and 1-year OS rate. * To evaluate the safety profile of HRS-4642 combined with AG as conversion therapy. * To assess changes in health-related quality of life from baseline using the EORTC QLQ-C30 and EORTC QLQ-PAN26 questionnaires in all participants.

Conditions

• Locally Advanced Pancreatic Cancer With KRAS G12D Mutation

Interventions

Type	Name	Description
DRUG	HRS-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.

Timeline

• Start date: 2026-01-28
• Primary completion: 2027-10-01
• Completion: 2027-12-01
• First posted: 2026-02-27
• Last updated: 2026-04-15

Locations

1 site across 1 country: China