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Brief Title: A Safety Study of SGN-35T in Adults With Advanced Cancers
Official Title: An Open-label Phase 1 Study to Evaluate the Safety of SGN-35T in Adults With Advanced Malignancies
Study ID: NCT06120504
Brief Summary: This clinical trial is studying lymphoma. Lymphoma is a cancer that starts in the blood cells that fight infections. There are several types of lymphoma. This study will enroll people who have lymphoma, such as classical Hodgkin lymphoma, peripheral T-cell lymphoma including systemic anaplastic large cell lymphoma, diffuse large B-cell lymphoma, or types of primary cutaneous lymphoma. This clinical trial uses a drug called SGN-35T. The study drug is in testing and has not been approved for sale. This is the first time SGN-35T will be used in people. The study drug will be given as an infusion through a vein. This study will test the safety of SGN-35T in participants with lymphoma. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. This study will have three parts. Parts A and B of the study will find out the best dose and dosing schedule for SGN-35T. Part C will use the dose found in parts A and B to find out how safe SGN-35T is and if it works to treat select lymphomas.
Detailed Description: This is a phase 1, open-label, multicenter study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of SGN-35T in adults with select relapsed/refractory lymphomas. SGN-35T is a CD30-directed antibody-drug conjugate and will be studied in patients with lymphomas expressing CD30.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Stanford Cancer Center / Blood and Marrow Transplant Program, Palo Alto, California, United States
University of Miami, Miami, Florida, United States
Regional Cancer Care Associates - Central Jersey, Hackensack, New Jersey, United States
University of Tennessee, Knoxville, Tennessee, United States
MD Anderson Cancer Center / University of Texas, Houston, Texas, United States
Name: Medical Monitor
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR