drugset / Trial / NCT07140393

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

NCT07140393

Phase 1/2 Recruiting 120 enrolled Jiangsu HengRui Medicine Co., Ltd.
Non-randomizedSequentialOpen-labelTreatment

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 HRS-4508 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.

Timeline

Start
2025-10-28
Primary completion
2027-10
Completion
2028-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule
Subject HRS-4508 Unknown
Subject Paclitaxel Small molecule
Subject Pertuzumab Monoclonal antibody
Subject Trastuzumab Monoclonal antibody
Subject Trastuzumab Rezetecan Monoclonal antibody

Indications