Actively Recruiting
A Study 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
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Evaluate the efficacy and safety of SH009 injection therapy for patients with advanced solid tumors
CONDITIONS
Official 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 consent, male or female
- Histologically confirmed locally advanced, recurrent, or metastatic solid tumors with progression or intolerance to at least one prior systemic therapy
- At least one measurable lesion according to RECIST 1.1 criteria
- Available archival tumor tissue or agreement to tumor biopsy for biomarker analysis
- ECOG Performance Status of 0 to 2
- Life expectancy of at least 12 weeks
- Adequate bone marrow function: neutrophils ≥ 1.5 x 10^9/L, platelets ≥ 90 x 10^9/L (≥75 x 10^9/L for liver cancer), hemoglobin ≥ 90 g/L
- Adequate liver function: total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for Gilbert's syndrome), AST and ALT ≤ 3 x ULN (≤ 5 x ULN for liver cancer or metastases)
- Adequate renal function: creatinine clearance ≥ 50 mL/min, urine protein < 2+, or 24-hour urine protein < 1g if ≥ 2+
- Coagulation parameters within 1.5 x ULN
- Use of effective contraception for females of childbearing potential and males during and for 6 months after the trial, with negative pregnancy test within 7 days before treatment
- Informed consent signed voluntarily
You will not qualify if you...
- Prior exposure to CD47 or SIRPα antibodies or recombinant proteins
- Prior adoptive cellular therapies like CAR-T, TCR-T, or TIL; recent anti-cancer vaccines or live vaccines within 4 weeks
- Recent systemic anti-tumor therapies within specified timeframes before dosing, including chemotherapy, targeted therapy, immunotherapy, or radiotherapy
- Participation in other investigational drug studies within 28 days or concurrent clinical studies
- Major surgery or significant trauma within 4 weeks before dosing or planned surgery during trial
- Recent systemic glucocorticoids or immunosuppressive therapy within 14 days before dosing (with exceptions)
- Symptomatic brain metastases unsuitable for enrollment
- Prior severe immune-related adverse events or myocarditis
- Severe or uncontrolled systemic diseases including cardiac, pulmonary, or hypertension conditions
- History of pneumonia requiring hormone therapy, interstitial lung disease, or active pulmonary infection
- Active infections requiring intravenous treatment or certain viral infections unless controlled
- History of immunodeficiency or HIV
- Other malignancies within 5 years except specific treated cancers
- Autoimmune diseases within 2 years except some stable conditions
- Recent arterial thromboembolic events or serious thromboembolism
- Prior allogeneic stem cell or solid organ transplantation (except corneal)
- Unresolved adverse reactions from prior anti-tumor therapy above specified grades
- Severe hypersensitivity to protein drugs or study components
- Alcohol or drug dependence or conditions affecting safety or compliance
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Gaobo Cancer Hospital
Shanghai, China
Actively Recruiting
Research Team
J
Jie Min
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here