Spots Global Cancer Trial Database for A Study of SGN-STNV in Advanced Solid Tumors
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Trial Identification
Brief Title: A Study of SGN-STNV in Advanced Solid Tumors
Official Title: A Phase 1 Study of SGN-STNV in Advanced Solid Tumors
Study ID: NCT04665921
Conditions
Interventions
Study Description
Brief Summary: This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors. The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.
Detailed Description: The study will include dose escalation (Part A) and dose expansion (Part B), with multiple disease-specific cohorts and a biology cohort in dose expansion. The biology cohort will require additional biopsies. At the completion of dose escalation, up to 5 disease specific expansion cohorts and 1 biology expansion cohort may be activated by the sponsor in consultation with the Safety Monitoring Committee (SMC). Expansion cohorts in Part B will enroll subjects with selected tumors that are eligible for enrollment in Part A. The dose(s) to be examined in Part B will be at or below the maximum tolerated dose and/or the recommended dose determined in Part A. The recommended dose and/or schedule may differ between cohorts.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Angeles Clinic and Research Institute, Los Angeles, California, United States
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies, San Francisco, California, United States
Shands Cancer Center / University of Florida, Gainesville, Florida, United States
University of Miami, Miami, Florida, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
South Texas Accelerated Research Therapeutics Midwest, Grand Rapids, Michigan, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Magee Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States
South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States
University of Ottawa / Ottawa General Hospital, Ottawa, Ontario, Canada
University Health Network, Princess Margaret Hospital, Toronto, Other, Canada
Institut Gustave Roussy, Villejuif Cedex, Other, France
Istituto Europeo di Oncologia, Milano, Other, Italy
Hospital Universitari Vall d'Hebron, Barcelona, Other, Spain
The Royal Marsden Hospital (Surrey), Sutton, Other, United Kingdom
Contact Details
Name: Suzanne McGoldrick, MD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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