NCT07140393

A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor

An Open, Multicenter Phase IB/II Clinical Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to evaluate the efficacy, safety, and ORR of HRS-4508 combination with other anti tumor therapy in subjects with solid tumor ; to evaluate HRS4508 DLT, MTD and RP2D, to evaluate the incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0), to evaluate ORR by researchers based on RECIST v1.1, to evaluate the pharmacokinetic (PK) characteristics of HRS-4508 SHR-1811, Capecitabine.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	HRS-4508+ Capecitabine	HRS-4508+ Capecitabine
DRUG	HRS-4508+ Trastuzumab	HRS-4508+ Trastuzumab
DRUG	HRS-4508+ Trastuzumab+ Pertuzumab	HRS-4508+ Trastuzumab+ Pertuzumab
DRUG	HRS-4508+ Trastuzumab+ Capecitabine	HRS-4508+ Trastuzumab+ Capecitabine
DRUG	Trastuzumab+ Capecitabine	Trastuzumab+ Capecitabine
DRUG	HRS-4508+A1811	HRS-4508+A1811

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-10-01
• Completion: 2028-10-01
• First posted: 2025-08-24
• Last updated: 2025-08-24

Locations

1 site across 1 country: China