Study of SGN1 for Advanced Solid Tumors
This study is testing a treatment called SGN1 for people with advanced solid tumors that haven't responded to standard treatments. SGN1 is given as an intravenous (IV) infusion, meaning it goes directly into your bloodstream. It works by targeting tumors that need a specific amino acid called methionine to grow, essentially starving them. Researchers want to see how safe SGN1 is and what side effects it might cause. They also want to understand if it can shrink tumors or stop them from growing. You might be able to join if you are between 18 and 75 years old and have certain types of advanced cancer, such as lung cancer or lymphoma, that are resistant to other therapies. The study plans to enroll about 70 participants.
- Study design
- This is an interventional study with an unclear phase, meaning it's testing a new treatment. It is an open-label study, so both you and the study team will know you are receiving SGN1. The study plans to enroll about 70 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be monitored for side effects from when you receive SGN1 until 28 days after your last dose. Your tumor response will be checked from when you sign the consent form until 28 days after your last dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of SGN1 in Patients With Advanced Solid Tumor
At a glance
Conditions
Where it's being run
8 sites across 8 statesWho to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Incidence and severity of AEs (adverse events).From receiving study drug and throughout the study, until 28 days after the last dosing.
An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. Events meeting the definition of an AE include: * Any abnormal laboratory test results (hematology, serum chemistry, or urinalysis) or other safety assessments (e.g., ECGs, vital signs measurements), including those that worsen from baseline, and was felt to be clinically significant in the medical and scientific judgment of the Investigator. * Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition. * New conditions detected or diagnosed after study treatment administration even though it may have been present prior to the start of the study. * Signs, symptoms, or the clinical sequelae of a suspected interaction.
- Incidence of SAEs.From receiving study drug and throughout the study, until 28 days after the last dosing.
An AE or suspected adverse reaction is considered "serious" if it results in any of the following outcomes: * Death * Life-threatening * Inpatient hospitalization or prolongation of existing hospitalization * A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions * A congenital anomaly/birth defect * Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.
- Objective response rate (ORR)From signing the informed consent form until 28 days after the last dose.
The efficacy endpoints include ORR, DCR and PFS. The ORR is defined as the proportion of patients who achieve PR or better according to the RECIST v1.1 and Choi, mRECIST is used to assess Hepatocellular carcinoma, and LYRIC is used to assess Lymphoma. as assessed by investigator.
- Disease control rate (DCR)From signing the informed consent form until 28 days after the last dose.
The efficacy endpoints include ORR, DCR and PFS. The DCR is defined as the proportion of patients who achieve SD or better according to the RECIST v1.1 and Choi , mRECIST is used to assess Hepatocellular carcinoma, and LYRIC is used to assess Lymphoma. as assessed by investigator.
- Progress Free Survival (PFS)From signing the informed consent form until 28 days after the last dose.
The efficacy endpoints include ORR, DCR and PFS. PFS is defined as the time interval from date of first dose of SGN1 to the date of documented disease progression (iRECIST is used when the subject is suspected to have pseudo disease progression) or death due to any cause, whichever occurs first.