BridgeMD
New treatment option for Liver Cancer (Locally Advanced or Metastatic)
Official title A Study of SH009 Injection in Patients With Advanced Solid Tumors.
ClinicalTrials.gov ID: NCT07390838
What this study is testing
What is SH009?
SH009 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for liver cancer (locally advanced or metastatic).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Evaluate the efficacy and safety of SH009 injection therapy for patients with advanced solid tumors
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- (1) Age≥18 years old at the time of informed consent, male or female;
- (2) people with histologically confirmed locally advanced, recurrent, or metastatic solid tumors (including but not limited to colorectal cancer...
- (3) people must have at least one measurable lesion per RECIST 1.1 criteria. A lesion that has been previously irradiated can only be considered...
- (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...
- (5) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2;
You likely can't join if
- (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...
- (3) Systemic anti-tumor therapies within the specified timeframes prior to the first dose of study drug: Chemotherapy, antibody-based targeted...
- (4) Received any investigational drug within 28 days before administration of this trial, or participated in another clinical study at the same time...
- (5) Had major organ surgery (excluding puncture biopsy) or had significant trauma within 4 weeks before the first administration, or needed to...
- (6) Patients who received systemic glucocorticoids (dexamethasone \> 10 mg/ day or equivalent dose of the same drug) or other immunosuppressive...
See the full eligibility criteria
Who can join
- (1) Age≥18 years old at the time of informed consent, male or female;
- (2) people 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...
- (3) people 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...
- (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 people with Gilbert's syndrome); aspartate aminotransferase (AST) and alanine and aminotransferase (ALT)...
- (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...
- (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 people 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...
- (12) The subject is fully informed about this trial before its commencement and voluntarily signs and dates the informed consent form.
What rules you out
- (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...
- (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...
- (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...
- (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...
- (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 judgment is acceptable). History of self-limited...
- (12) Active Hepatitis B, Hepatitis C, or syphilis infection. people positive for HBeAb or HBsAg are eligible if HBV-DNA ≤200 IU/mL. people positive for HCV-Ab are eligible if HCV-RNA ≤ the upper limit of normal at the...
- (13) History of primary immunodeficiency, including positive human immunodeficiency virus (HIV) test, or suffering from other acquired, congenital immunodeficiency diseases;
- (14) History of other malignancies within 5 years prior to the first dose, except for: a) Any other invasive malignancy, treated with curative intent, with a disease-free interval \>3 years and deemed by the...
- (15) History or presence of autoimmune disease within 2 years, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis...
- (16) Arterial thromboembolic events within 6 months prior to the first dose, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack. History of deep vein thrombosis...
- (17) people who had receive allogeneic hematopoietic stem cell transplantation or solid organ transplantation (except corneal transplant);
- (18) According to CTCAE 5.0, adverse reactions from previous anti-tumor therapy have not yet returned to ≤ grade 1 (except for toxicities which are judged by researchers to be safe, such as hair loss, pigmentation...
- (19) Known history of severe hypersensitivity to macromolecular protein preparations/monoclonal antibodies(CTCAE v5.0 Grade ≥3), or any component of the study drug;
- (20) Known alcohol and/or drug dependence, or any other condition deemed by the investigator to affect the safety or compliance of the study treatment, including but not limited to psychiatric disorders;
- (21) Pregnant or lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.