NCT06770452

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study used a Simon two-stage design, with at least 15 subjects enrolled in the first stage. During this period, after 6-9 subjects complete the first cycle of treatment, the existing safety data shall be summarized and analyzed to integrate the safety results to assess the tolerance. If tolerated, the proposed dose, other dose level or dosage regimen shall be discussed by investigators. As with\> 5 achieved remission (CR / PR), enrollment continued to 32; if 5 were remitted, the SMC assessed assessed and decided. The study process included screening, treatment and follow-up periods (safety and survival follow-up after termination of study treatment).

Conditions

• Metastatic Pancreatic Carcinoma

Interventions

Type	Name	Description
DRUG	HRS-4642	HRS-4642 is a KRAS G12D inhibitor
DRUG	Nimotuzumab	Nimotuzumab is a humanized IgG 1 monoclonal antibody targeting EGFR
DRUG	gemcitabine + nab-paclitaxel	Albumin paclitaxel 125mg/m2 intravenous infusion, gemcitabine 1000mg / m2, D1,8, a cycle every 3 weeks

Timeline

• Start date: 2025-03-25
• Primary completion: 2027-02-01
• Completion: 2028-02-01
• First posted: 2025-01-13
• Last updated: 2025-09-23

Locations

2 sites across 1 country: China