NCT06427239

Exploratory Clinical Study of HRS-4642 Combined With Adebelimab in the Treatment of Advanced Pancreatic Cancer

A Single-center, Open-label, Exploratory Study of HRS-4642 Combined With Adebelimab in the Treatment of Advanced Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to evaluate the safety, tolerability and efficacy of HRS-4642 combined with adebelimab in subjects with locally advanced or metastatic pancreatic ductal adenocarcinoma.

Detailed description

This study is an open, single center, exploratory clinical trial aimed at evaluating the efficacy and safety of HRS-4642 combined with adebelimab in the treatment of patients with unresectable locally advanced or metastatic pancreatic ductal adenocarcinoma. This study experiment is divided into two stages: dose exploration stage and efficacy exploration stage. During the dose exploration phase, RP2D was determined based on the safety, tolerability, and preliminary efficacy data of HRS-4642 combined with adelbizumab treatment, and then entered the efficacy exploration phase.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	HRS-4642	HRS-4642 will be administrated per dose level in which the patients are assigned.
DRUG	Adebrelimab	Adebrelimab will be administrated per dose level in which the patients are assigned

Timeline

• Start date: 2024-05-29
• Primary completion: 2026-06-01
• Completion: 2026-09-01
• First posted: 2024-05-23
• Last updated: 2024-08-09

Locations

1 site across 1 country: China