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

Recruiting now · Phase 1/Phase 2

Conditions studied: Solid Tumor

In brief

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.

Key facts

Study ID

NCT07140393

Run by

Jiangsu HengRui Medicine Co., Ltd.

People needed

120

Starts

2025-10-28

Expected to finish

2028-10-01

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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;

Where it is running

• Cancer Hospital Chinese Academy of Medical Science — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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