OncoMatch/Clinical Trials/NCT07390838
A Study of SH009 Injection in Patients With Advanced Solid Tumors.
Is NCT07390838 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies SH009 for liver cancer (locally advanced or metastatic).
Treatment: SH009 — Evaluate the efficacy and safety of SH009 injection therapy for patients with advanced solid tumors
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Non-Small Cell Lung Carcinoma
Head and Neck Squamous Cell Carcinoma
Breast Carcinoma
Esophageal Carcinoma
Gastric Cancer
Tumor Agnostic
Biomarker criteria
Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)
Required: CD47 any tested (testing required; no eligibility threshold specified)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: CD47/SIRPα-targeted therapy
Prior exposure to any CD47 antibody, SIRPα antibody, or CD47/SIRPα recombinant protein
Cannot have received: adoptive cellular therapy
Prior treatment with adoptive cellular therapies such as CAR-T, TCR-T, or TIL
Cannot have received: anti-cancer vaccine
Prior administration of an anti-cancer vaccine, or use of live or live-attenuated vaccines within 4 weeks prior to the first dose
Cannot have received: chemotherapy, antibody-based targeted therapy, endocrine therapy, or immunotherapy
Systemic anti-tumor therapies within the specified timeframes prior to the first dose of study drug: Chemotherapy, antibody-based targeted therapy, endocrine therapy, or immunotherapy within 3 weeks
Cannot have received: mitomycin or nitrosoureas
Mitomycin or nitrosoureas within 6 weeks
Cannot have received: oral fluoropyrimidines and small molecule targeted agents (S-1, capecitabine)
Oral fluoropyrimidines (e.g., S-1, capecitabine) and small molecule targeted agents within 2 weeks or 5 half-lives of the drug (whichever is longer)
Cannot have received: Chinese/herbal medicines with anti-cancer activity
Chinese/herbal medicines with anti-cancer activity indicated in their labeling must be discontinued prior to enrollment
Cannot have received: radical radiotherapy
Prior radical radiotherapy within 3 months before study drug administration is excluded
Lab requirements
Blood counts
neutrophil count ≥ 1.5 × 10^9/L; platelet count ≥ 90 × 10^9/L (≥ 75 × 10^9/L in liver cancer); hemoglobin ≥ 90 g/L
Kidney function
serum creatinine clearance ≥ 50 mL/min (Cockcroft-Gault); urine protein < 2+ or if ≥2+ then 24-hour urine protein <1g
Liver function
total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert's syndrome); AST and ALT ≤ 3 × ULN (≤ 5 × ULN for liver cancer or liver metastases)
Bone marrow function meets the following criteria: neutrophil count ≥ 1.5 × 10^9/L; platelet count ≥ 90 × 10^9/L (platelet count ≥ 75 × 10^9/L in patients with liver cancer); hemoglobin (Hb) ≥ 90 g/L; Liver function meets the following criteria: total bilirubin(TBIL) ≤ 1.5 × ULN (total bilirubin ≤ 3 × ULN for subjects with Gilbert's syndrome); aspartate aminotransferase (AST) and alanine and aminotransferase (ALT) ≤ 3 × ULN (ALT and AST ≤ 5 × ULN for subjects with liver cancer or liver metastases); Renal function meets the following criteria: serum creatinine clearance(CLcr) ≥ 50 mL/min (calculated according to Cockcroft-Gault formula); urine dipstick test results show that urine protein < 2 +, urine protein ≥ 2 + subjects should undergo 24-hour urine collection and urine protein content < 1g within 24 hours; Coagulation function meets the following criteria: prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5× ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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