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New treatment option for Advanced Solid Tumor
Official title Study of SGN1 in Patients With Advanced Solid Tumor
ClinicalTrials.gov ID: NCT05038150
What this study is testing
What is SGN1?
SGN1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
Also referred to as SalMet-Vec.
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
- Objectives:To assess the safety and tolerability followed by a dose expansion study to characterize safety, and preliminary efficacy of SGN1 in participants with refractory solid tumors. Study Rationale:The mechanism of action for SGN1 is based on the fact that most tumors are methionine dependent.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients must meet all the following
- Age 18-75 years inclusive of end value, regardless of gender.
- Part 1: Patients with advanced stage (unresectable or metastatic) cancer including but not limited to small cell lung cancer, non-small cell lung...
- Patients finished anti-tumor therapy including chemotherapy, immunotherapy, biological agents, hormone therapy, radiotherapy (except local...
- At least 1 measurable lesion according to RECIST 1.1 (for solid tumors).
You likely can't join if
- Patients will be excluded from participation for any of the following criteria:
- Received systemic or absorbable dosage of steroid hormone (prednisone or equivalent) of \> 10 mg/day in the 14 days prior to enrollment;
- Prednisone \> 10 mg/day
- Dexamethasone \> 1.5 mg/day.
- Allergic or intolerant to salmonella sensitive antibiotics, or combined with infectious diseases and currently using antibiotics.
- Present assessable tumors in hollow organs (Stomach, esophagus, intestine, urinary tract etc.).
See the full eligibility criteria
Who can join
- Patients must meet all the following
- Age 18-75 years inclusive of end value, regardless of gender.
- Part 1: Patients with advanced stage (unresectable or metastatic) cancer including but not limited to small cell lung cancer, non-small cell lung cancer (adeno- and squamous), Hodgkin's lymphoma or non-Hodgkin's...
- Patients finished anti-tumor therapy including chemotherapy, immunotherapy, biological agents, hormone therapy, radiotherapy (except local radiotherapy for pain relief) ≥ 4 weeks prior to the first dose of study drug.
- At least 1 measurable lesion according to RECIST 1.1 (for solid tumors).
- Patients have recovered from any toxic reaction to previous medications (≤Grade 1 based on NCI-CTCAE v 5.0, except a. Hair loss; b. Pigmentation; c. The long-term toxicity caused by radiotherapy and cannot be recovered...
- Eastern Co-Operative Oncology Group (ECOG) performance status 0 \~ 1 and a life expectancy of at least 3 months.
- Laboratory tests must meet the following requirements and have not received any blood cell growth factor 14 days before the test (Patients with laboratory values outside of the specified ranges will be permitted to be...
- absolute count of neutrophils (ANC) ≥1.5×109 /L, platelet ≥75×109 /L; Hemoglobin ≥90 g/L;
- serum albumin ≥30g /L; Bilirubin ≤1.5 × Upper Limit of Normal (ULN), ALT and AST ≤2.5 × ULN;
- In patients with liver metastasis,ALT and AST≤5 × ULN;
- Creatinine clearance ≥50 mL/min (standard Cockcroft -Gault formula) or Cr ≤1.5 ×ULN: urinary protein≤ 2+ or urinary protein quantitative \<1.0 g/L;
- International standardized ratio of coagulation function (INR) ≤1.5 × ULN, activated partial thromboplastin time (APTT) ≤1.5 × ULN (If patient has concomitant medication with anticoagulants, whether the coagulation...
- If female, be either postmenopausal for at least 1 year with documented follicle stimulating hormone (FSH) \> 30 IU/L, or surgically sterile for at least 3 months, or if a woman of childbearing potential, must be...
- Female patients of childbearing potential must agree to use acceptable method(s) of contraception from consent through at least 6 months after last dose of drug infusion.
- Male patients of reproductive capacity must agree to use effective contraception from start of mobilization through at least 6 months after last dose of drug infusion.
- Patients with chronic HBV infection with active disease who meet the criteria for anti HBV therapy (HBV DNA test is less than 2000 IU/ml) should be on a suppressive antiviral therapy prior to initiation of cancer...
- Patients must be able to follow up after the treatment.
- Patients must understand and voluntarily sign the informed consent form.
What rules you out
- Patients will be excluded from participation for any of the following criteria:
- Received systemic or absorbable dosage of steroid hormone (prednisone or equivalent) of \> 10 mg/day in the 14 days prior to enrollment;
- Prednisone \> 10 mg/day
- Dexamethasone \> 1.5 mg/day.
- Allergic or intolerant to salmonella sensitive antibiotics, or combined with infectious diseases and currently using antibiotics.
- Present assessable tumors in hollow organs (Stomach, esophagus, intestine, urinary tract etc.).
- Present with symptomatic central nervous system metastasis or brain abscess at screening.
- Present with diverticulitis or conditions at screening that might promote the unintentional growth of anaerobic bacteria in non target lesions.
- Existing cardiac clinical symptoms or diseases that cannot be well controlled, such as:
- NYHA grade 2 or above heart failure;
- Unstable angina pectoris;
- Myocardial infarction occurred within 1 year;
- Patients with supraventricular or ventricular arrhythmias that have clinical significance and need treatment or intervention;
- Uncontrolled hypertension (systolic blood pressure) ≥160 mmHg and (diastolic blood pressure) ≥100 mmHg after drug treatment;
- Patients with valvular heart disease or mitral valve prolapse, aortic valve disease or other source of turbulent cardiac blood flow.
- Those who had received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy that ended fewer than 4 weeks before the first dose of study treatment (if nitrosourea or mitomycin chemotherapy...
- Patients with active or uncontrolled infection or fever, \> 38.5℃, of unknown cause during screening or before the first administration of the study drug (according to the judgment of the researcher, fever caused by...
- Positive for the presence of human immunodeficiency virus-1 (HIV-1) or human immunodeficiency virus-2 (HIV-2) (positive antigen/antibody and nucleic acid tests); or follow standard of care for HIV diagnosis.
- Patients with Anti-TP positive.
- Patients participating in other clinical studies or participating in other clinical studies within 4 weeks (or 5 half-lives of other study drugs), whichever is longer, prior to enrollment and receiving experimental drug...
- Vaccination within 28 days of the first trial treatment, except for administration of inactivated vaccines and RNA vaccines (e.g., inactivated influenza vaccines and COVID-19 RNA vaccines).
- Received live or attenuated vaccines within 4 weeks of study drug administration, during treatment, or within 5 months of the last administration.
- In the judgment of the investigator, there are other factors that may lead to termination: for example, adrenal cortex insufficiency, pituitary insufficiency after treatment, and other serious diseases (including...
- In the researcher's judgment, patients who are not suitable for other reasons.
- Documented salmonella infections within 6 months.
- Abdominal standing position plain film or abdominal CT indicates the possibility of bowel obstruction within 6 months from screening, or the Investigator believes there is a risk of bowel obstruction.
- Patients with implants such as pacemakers, prosthetic cardiac valves, or metal orthopedic prostheses (not include vascular implants for Part 3).
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Orange, California, United States
- Detroit, Michigan, United States
- Cincinnati, Ohio, United States
- Guangzhou, Guangdong, China
- Harbin, Heilongjiang, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Orange, California, United States; Detroit, Michigan, United States; Cincinnati, Ohio, United States; Guangzhou, Guangdong, China; Harbin, Heilongjiang, China and 2 more location(s). 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.