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

Not Applicable

Not yet recruiting

• Conditions: Solid Tumor
• Interventions: Drug: HRS-4508+ Capecitabine; Drug: HRS-4508+ Trastuzumab; Drug: HRS-4508+ Trastuzumab+ Pertuzumab; Drug: HRS-4508+ Trastuzumab+ Capecitabine; Drug: Trastuzumab+ Capecitabine; Drug: HRS-4508+A1811

• Registration Number: NCT07140393
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-17
• Study First Submitted QC: 2025-08-18
• Last Update Submitted: 2025-08-18
• Study First Posted: 2025-08-24
• Last Update Posted: 2025-08-24
• Study Start: 2025-10-01
• Primary Completion: 2027-10
• Study Completion: 2028-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age: 18 to 75 years old; Both men and women are welcome;
2. The mixed cell types need to be confirmed by histology or cytology, and the dominant cell morphology, unresectable or metastatic .
3. ECOG ratings of 0 or 1.
4. Expected survival period ≥ 12 weeks.
5. At least one measurable lesion outside the central nervous system that meets the RECIST v1.1 standard definition.
6. Willing to participate and comply with the requirements of the research protocol, and willing to cooperate with follow-up visits.

Exclusion Criteria

1. Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis
2. There have been significant severe infections and major surgeries in the past 4 weeks
3. Existence of previous or concurrent malignant tumors
4. Difficult to treat nausea, vomiting, or other gastrointestinal diseases that affect the use of oral medication
5. Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HRS-4508+ Capecitabine	HRS-4508+ Capecitabine	-
HRS-4508+ Trastuzumab	HRS-4508+ Trastuzumab	-
HRS-4508+ Trastuzumab+ Pertuzumab	HRS-4508+ Trastuzumab+ Pertuzumab	-
HRS-4508+ Trastuzumab+ Capecitabine	HRS-4508+ Trastuzumab+ Capecitabine	-
Trastuzumab+ Capecitabine	Trastuzumab+ Capecitabine	-
HRS-4508+A1811	HRS-4508+A1811	-

Primary Outcome Measures

Name	Time	Method
HRS4508 DLT	3 weeks
HRS4508 MTD	12 weeks
HRS4508 RP2D	12 weeks
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)	2 years
Objective response rate (ORR)	1 year

Secondary Outcome Measures

Name	Time	Method
Blood concentrations of HRS-4508	15 weeks
Blood concentrations of SHR-A1811	9 weeks
Blood concentrations of Capecitabine	2 weeks
Objective response rate (ORR)	1 year
Best overall efficacy (BOR)	1 year
Duration of response (DoR)	1 year
Progression free survival (PFS)	1 year
Disease control rate (DCR)	1 year
Overall survival (OS)	2 year
The incidence and severity of adverse events (AE)/serious adverse events (SAE) (rated based on CTCAE v5.0)	2 years

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Science; 🇨🇳 Beijing, Beijing, China