A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor
NCT07140393 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2025-08-24
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
Interventions
- 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
Sponsors & Collaborators
-
Jiangsu HengRui Medicine Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-31
- Primary Completion
- 2027-10-31
- Completion
- 2028-10-31
Countries
- China
Study Locations
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