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Recruiting Phase 1 NCT07390838

A Study of SH009 Injection in Patients With Advanced Solid Tumors.

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Trial Parameters

Condition Liver Cancer (Locally Advanced or Metastatic)
Sponsor Nanjing Sanhome Pharmaceutical, Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 150
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-05-16
Completion 2026-12-30
Interventions
SH009

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Brief Summary

Evaluate the efficacy and safety of SH009 injection therapy for patients with advanced solid tumors

Eligibility Criteria

Inclusion Criteria: * (1) Age≥18 years old at the time of informed consent, male or female; * (2) Subjects with histologically confirmed locally advanced, recurrent, or metastatic solid tumors (including but not limited to colorectal cancer, gastric cancer, hepatocellular carcinoma, head and neck cancer, breast cancer, non-small cell lung cancer, esophageal cancer, etc.) who have experienced disease progression or intolerance to at least one prior line of systemic therapy, and for whom no acceptable standard therapy exists or who cannot benefit from or tolerate standard therapy; * (3) Subjects must have at least one measurable lesion per RECIST 1.1 criteria. A lesion that has been previously irradiated can only be considered measurable if there is documented progression at that site following radiotherapy; * (4) Archival tumor tissue samples are available, or the subject agrees to undergo a tumor biopsy for the determination of PD-L1 and CD47 expression levels and other biomarker analy

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