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
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2025
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2025
CompletedFirst Posted
Study publicly available on registry
August 24, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
August 24, 2025
August 1, 2025
2 years
August 17, 2025
August 18, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (6)
HRS-4508+ Capecitabine
EXPERIMENTALHRS-4508+ Trastuzumab
EXPERIMENTALHRS-4508+ Trastuzumab+ Pertuzumab
EXPERIMENTALHRS-4508+ Trastuzumab+ Capecitabine
EXPERIMENTALTrastuzumab+ Capecitabine
EXPERIMENTALHRS-4508+A1811
EXPERIMENTALInterventions
HRS-4508+ Trastuzumab+ Pertuzumab
HRS-4508+ Trastuzumab+ Capecitabine
Eligibility Criteria
You may qualify if:
- Age: 18 to 75 years old; Both men and women are welcome;
- The mixed cell types need to be confirmed by histology or cytology, and the dominant cell morphology, unresectable or metastatic .
- ECOG ratings of 0 or 1.
- Expected survival period ≥ 12 weeks.
- At least one measurable lesion outside the central nervous system that meets the RECIST v1.1 standard definition.
- Willing to participate and comply with the requirements of the research protocol, and willing to cooperate with follow-up visits.
You may not qualify if:
- Accompanied by untreated or active central nervous system (CNS) tumor metastasis. Subjects with a history of meningeal metastasis or current meningeal metastasis
- There have been significant severe infections and major surgeries in the past 4 weeks
- Existence of previous or concurrent malignant tumors
- Difficult to treat nausea, vomiting, or other gastrointestinal diseases that affect the use of oral medication
- Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2025
First Posted
August 24, 2025
Study Start
October 1, 2025
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2028
Last Updated
August 24, 2025
Record last verified: 2025-08