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About
This clinical trial is studying advanced solid tumors. Solid tumors are cancers that start in a part of your body like your lungs or liver instead of your blood. Once tumors have grown bigger in one place but haven't spread, they're called locally advanced. If your cancer has spread to other parts of your body, it's called metastatic. When a cancer has gotten so big it can't easily be removed or has spread to other parts of the body, it is called unresectable. These types of cancer are harder to treat.
Patients in this study must have cancer that has come back or did not get better with treatment. Patients must have a solid tumor cancer that can't be treated with standard of care drugs.
This clinical trial uses an experimental drug called SGN-MesoC2. SGN-MesoC2 is a type of antibody-drug conjugate (ADC). ADCs are designed to stick to cancer cells and kill them. They may also stick to some normal cells.
This study will have 3 parts. Part A and Part B of the study will find out how much SGN-MesoC2 should be given to participants. Part C will use the information from Parts A and B to see if SGN-MesoC2 is safe and if it works to treat solid tumor cancers.
Enrollment
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Inclusion criteria
Exclusion criteria
Participants previously received or is currently receiving the following anticancer medications or investigational drugs will be excluded:
Major surgery (excluding placement of vascular access) within 4 weeks, or minor surgery within 7 days, prior to first dose of study intervention. Participants must have recovered adequately from the toxicity or complications from the surgery prior to starting SGN-MesoC2. Participants who have planned major surgery during the treatment period must be excluded from the study.
History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
Known to be positive for human immunodeficiency virus (HIV). Participants with severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, or active bleeding diatheses.
Participants with medical history of clinically significant lung diseases (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or who are suspected to have these diseases by imaging at screening period.
Previously untreated brain metastases. Participants who have received radiation or surgery for brain metastases are eligible if therapy was completed at least 4 weeks prior to initiation of study treatment, there is no evidence of central nervous system (CNS) disease progression, and there is no requirement for chronic corticosteroid therapy. Leptomeningeal metastases or spinal cord compression due to disease.
Primary purpose
Allocation
Interventional model
Masking
365 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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