Actively Recruiting
An Open, Multicenter, Phase I Study on the Safety, Efficacy, and Pharmacokinetics of SH009 Injection in Patients With Advanced Solid Tumors
Led by Nanjing Sanhome Pharmaceutical, Co., Ltd. · Updated on 2026-02-05
150
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and behavior in the body of SH009 injection therapy in patients with advanced solid tumors. This Phase I clinical study focuses on various tumor types including gastric, liver, head and neck, breast, non-small cell lung, and esophageal cancers. The aim is to select safe and effective tumor types and doses for further studies and to help determine the recommended dose for future trials. Participants will receive SH009 at a dose of 40 mg/kg once weekly, with treatment cycles lasting 28 days. The study includes dose expansion to assess safety, efficacy, and pharmacokinetics. It is an open, multicenter trial with no placebo or masking, focusing on patients whose cancer has progressed or who cannot tolerate standard treatments. During the study, participants will undergo regular assessments including measuring tumor response, survival rates, and monitoring side effects for up to two years. Researchers will collect tumor tissue samples for biomarker analysis and monitor blood levels of the drug and immune responses. Safety will be closely followed from consent through 90 days after the last dose, with long-term follow-up of treatment effects and survival outcomes.
CONDITIONS
Brief Title
A Study of SH009 Injection in Patients With Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of informed consent, male or female
- Histologically confirmed locally advanced, recurrent, or metastatic solid tumors with disease progression or intolerance to at least one prior systemic therapy
- At least one measurable lesion per RECIST 1.1 criteria
- Archival tumor tissue samples available or agreement to undergo tumor biopsy for biomarker analysis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 12 weeks
- Bone marrow function meeting specified neutrophil, platelet, and hemoglobin counts
- Liver function within specified limits including bilirubin and liver enzyme levels
- Renal function with serum creatinine clearance of 50 mL/min or higher and urine protein within specified limits
- Coagulation function within specified limits for prothrombin time, APTT, and INR
- Use of effective contraception during the trial and for 6 months after last dose for females of childbearing potential and males
- Voluntary informed consent signed before trial commencement
You will not qualify if you...
- Prior exposure to CD47 or SIRPalpha antibodies or recombinant proteins
- Prior adoptive cellular therapies or anti-cancer vaccines within 4 weeks before first dose
- Recent systemic anti-tumor therapies within specified timeframes before first dose
- Participation in another clinical study or investigational drug use within 28 days before trial
- Major surgery or significant trauma within 4 weeks before first dose
- Recent systemic glucocorticoids or immunosuppressive therapy within 14 days before first dose
- Symptomatic brain metastases unsuitable for enrollment
- Prior severe immune-related adverse events or myocarditis
- Severe or uncontrolled systemic diseases including certain heart, lung, and infection conditions
- Active infections requiring intravenous treatment within 1 week before study drug administration
- Active hepatitis B, C, or syphilis infection unless controlled
- History of immunodeficiency including positive HIV test
- Other malignancies within 5 years except certain treated cancers
- Autoimmune diseases within 2 years except stable or mild conditions
- Recent arterial thromboembolic events or serious thromboembolism
- Prior allogeneic stem cell or solid organ transplant except corneal
- Ongoing adverse reactions from previous anti-tumor therapy above specified grades
- Known severe hypersensitivity to protein or monoclonal antibody treatments
- Alcohol or drug dependence or psychiatric disorders affecting safety or compliance
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive SH009 injections to treat their advanced solid tumors while being monitored for safety, efficacy, and pharmacokinetics.
Weekly visits for SH009 injections and assessments during each 28-day cycle
Duration - Up to 2 years after last dose
Participants are monitored for adverse events and long-term outcomes after completing treatment with SH009.
Periodic visits for up to 2 years after treatment ends
Trial Site Locations
Total: 1 location
1
Shanghai Gaobo Cancer Hospital
Shanghai, China
Actively Recruiting
Research Team
J
Jie Min
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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