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

RecruitingPhase 1Ages 18 Years - anyAllNanjing Sanhome Pharmaceutical, Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 analyses; * (5) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2; * (6) Life expectancy ≥12 weeks; * (7) 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; * (8) 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); * (9) 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; * (10) Coagulation function meets the following criteria: prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5× ULN; * (11) Female subjects of childbearing potential must use effective contraception during the trial and for 6 months after the last dose, and have a negative pregnancy test within 7 days before treatment initiation (except those who are surgically sterilized or postmenopausal). Male subjects must agree to use effective contraception during the trial and for 6 months after the last dose; * (12) The subject is fully informed about this trial before its commencement and voluntarily signs and dates the informed consent form. Exclusion Criteria: * (1) Prior exposure to any CD47 antibody, SIRPα antibody, or CD47/SIRPα recombinant protein; * (2) Prior treatment with adoptive cellular therapies such as CAR-T, TCR-T, or TIL. Prior administration of an anti-cancer vaccine, or use of live or live-attenuated vaccines within 4 weeks prior to the first dose; * (3) 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. Mitomycin or nitrosoureas within 6 weeks. 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).Chinese/herbal medicines with anti-cancer activity indicated in their labeling must be discontinued prior to enrollment. Prior radical radiotherapy within 3 months before study drug administration is excluded. Palliative radiotherapy administered within 2 weeks prior to dosing is allowed if the dose meets local palliative care standards and the radiation field covers less than 30% of the bone marrow area; * (4) Received any investigational drug within 28 days before administration of this trial, or participated in another clinical study at the same time, except for the following circumstances: the patient participated in an observational, non-interventional clinical study, or was in the follow-up period after the end of treatment in an interventional clinical study but the drug withdrawal had exceeded the washout period; * (5) Had major organ surgery (excluding puncture biopsy) or had significant trauma within 4 weeks before the first administration, or needed to undergo elective surgery during the trial period; * (6) Patients who received systemic glucocorticoids (dexamethasone \> 10 mg/ day or equivalent dose of the same drug) or other immunosuppressive therapy within 14 days before the first administration; except for topical, ocular, intra-articular, intranasal, and inhaled glucocorticoids; short-term use of glucocorticoids for prophylactic treatment (e.g., prevention of contrast allergy); * (7) Symptomatic brain parenchymal or leptomeningeal metastases, deemed by the investigator as unsuitable for enrollment; * (8) Prior immunotherapy with ≥Grade 3 irAE or ≥Grade 2 immune-related myocarditis; * (9) Severe or uncontrolled systemic disease, including but not limited to: uncontrolled pleural or peritoneal effusion; uncontrolled diabetes; ventricular arrhythmia requiring intervention; acute coronary syndrome, congestive heart failure, stroke, or other ≥Grade 3 cardiovascular event within 6 months; NYHA Class ≥II or LVEF \<50%; clinically significant QTcF prolongation or arrhythmia risk (baseline QTcF \>450 msec for males or \>470 msec for females); clinically uncontrolled hypertension (SBP \>160 mmHg and/or DBP \>90 mmHg after treatment) as judged by the investigator. Subjects judged by the investigator as unsuitable due to any such condition; * (10) History of pneumonia requiring hormone therapy or interstitial lung disease (including past and current history); active pulmonary infection; * (11) Active infection requiring intravenous anti-infective therapy within 1 week prior to study drug administration (fever attributed to the tumor per investigator's jud
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What it tests

  • SH009
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Where

1 site
Shanghai Gaobo Cancer Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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