Status:
NOT_YET_RECRUITING
A Study of HRS-4508 in Combination With Other Anti-tumor Therapy for Solid Tumor
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 ev...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07140393
Start Date
October 1 2025
End Date
October 1 2028
Last Update
August 24 2025
Active Locations (1)
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1
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China, 100021