NCT06547736

Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer

A Single-center, Open-label, Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (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 ADC drugs monotherapy or combination therapy with HRS-4642 or immunotherapy in subjects with locally advanced or metastatic pancreatic cancer.

Detailed description

This study is an open, single center, exploratory clinical trial aimed at evaluating the efficacy and safety of ADC drugs monotherapy or combination therapy with HRS-4642 or immunotherapy in the treatment of patients with unresectable locally advanced or metastatic pancreatic cancer. 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 ADC drugs monotherapy or combination therapy with HRS-4642 or immunotherapy, and then entered the efficacy exploration phase.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	SHR-A2102 or/and HRS-4642	Drug: SHR-A2102 SHR-A2102 will be administrated per dose level in which the patients are assigned. Drug: HRS-4642 HRS-4642 will be administrated per dose level in which the patients are assigned.
DRUG	SHR-A1904 or/and HRS-4642	Drug: SHR-A1904 SHR-A1904 will be administrated per dose level in which the patients are assigned. Drug: HRS-4642 HRS-4642 will be administrated per dose level in which the patients are assigned.
DRUG	SHR-A1811 or/and HRS-4642	Drug: SHR-A1811 SHR-A1811 will be administrated per dose level in which the patients are assigned. Drug: HRS-4642 HRS-4642 will be administrated per dose level in which the patients are assigned.
DRUG	SHR-A2102, HRS4642 and Adebrelimab	Drug: SHR-A2102 SHR-A2102 will be administrated per dose level in which the patients are assigned. 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: 2024-10-14
• Primary completion: 2027-03-01
• Completion: 2027-06-01
• First posted: 2024-08-09
• Last updated: 2026-01-05

Locations

1 site across 1 country: China