A Safety Study of SEA-TGT (SGN-TGT) in Advanced Cancer
- Conditions
- Non-small Cell Lung CancerGastric CarcinomaGastroesophageal Junction CarcinomaClassical Hodgkin LymphomaDiffuse Large B-cell LymphomaPeripheral T-cell LymphomaCutaneous MelanomaHead and Neck Squamous Cell CarcinomaBladder CancerOvarian Cancer
- Interventions
- Registration Number
- NCT04254107
- Lead Sponsor
- Seagen Inc.
- Brief Summary
This trial will look at a drug called SEA-TGT (also known as SGN-TGT) to find out whether it is safe for patients with solid tumors and lymphomas. It will study SEA-TGT to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether SEA-TGT works to treat solid tumors and lymphomas.
The study will have four parts. Part A of the study will find out how much SEA-TGT should be given to patients. Part B will use the dose found in Part A to find out how safe SEA-TGT is and if it works to treat solid tumors and lymphomas. Part C will study how well SEA-TGT with sasanlimab works to treat solid tumors. Part D will study how well SEA-TGT with brentuximab vedotin works to treat classical Hodgkin lymphoma (cHL).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 133
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description SEA-TGT Monotherapy (Parts A and B) SEA-TGT SEA-TGT SEA-TGT + sasanlimab Combination Therapy (Part C) SEA-TGT SEA-TGT + sasanlimab SEA-TGT + sasanlimab Combination Therapy (Part C) sasanlimab SEA-TGT + sasanlimab SEA-TGT + brentuximab vedotin Combination Therapy (Part D) SEA-TGT SEA-TGT + brentuximab vedotin SEA-TGT + brentuximab vedotin Combination Therapy (Part D) brentuximab vedotin SEA-TGT + brentuximab vedotin
- Primary Outcome Measures
Name Time Method Number of participants with a dose-limiting toxicity (DLT) at each dose level Up to 21 days To be summarized using descriptive statistics
Number of participants with adverse events (AEs) Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years An AE is any untoward medical occurrence in a subject or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Number of participants with laboratory abnormalities by grade Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years To be summarized using descriptive statistics
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) Up to approximately 3 years Proportion of participants with complete response (CR) and partial response (PR) per the participant's specific tumor response criteria
Duration of overall survival Up to approximately 3 years Time from start of study treatment to the date of death due to any cause
Area under the concentration-time curve (AUC) Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years To be summarized using descriptive statistics.
Time to maximum concentration (tmax) Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years To be summarized using descriptive statistics.
Complete response (CR) rate Up to approximately 3 years Proportion of participants with CR per the participant's specific tumor response criteria
Duration of objective response Up to approximately 3 years Time from first response to the first documentation of disease progression or death due to any cause
Maximum concentration (Cmax) Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years To be summarized using descriptive statistics.
Trough concentration (Ctrough) Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years To be summarized using descriptive statistics.
Duration of CR Up to approximately 3 years Time from start of the first documentation of CR to the first documentation of confirmed tumor progression or to death due to any cause, whichever comes first
Duration of progression-free survival Up to approximately 3 years Time from first dose to the first documentation of disease progression or death due to any cause
Number of participants with antidrug antibodies (ADA) Through 45-52 days following last dose of SEA-TGT; up to approximately 3 years To be summarized using descriptive statistics.
Trial Locations
- Locations (36)
California Research Institute
🇺🇸Los Angeles, California, United States
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
Texas Oncology - Baylor Sammons Cancer Center
🇺🇸Dallas, Texas, United States
Virginia Cancer Specialists, PC
🇺🇸Fairfax, Virginia, United States
Maryland Oncology Hematology, P.A.
🇺🇸Rockville, Maryland, United States
MD Anderson Cancer Center / University of Texas
🇺🇸Houston, Texas, United States
Johns Hopkins Medical Center
🇺🇸Baltimore, Maryland, United States
Sarah Cannon Research Institute UK
🇬🇧London, Other, United Kingdom
The Royal Marsden Hospital (Surrey)
🇬🇧Sutton, Other, United Kingdom
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
🇺🇸San Francisco, California, United States
Minnesota Oncology Hematology P.A.
🇺🇸Minneapolis, Minnesota, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
City of Hope
🇺🇸Duarte, California, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
University of Cincinnati Cancer Institute
🇺🇸Cincinnati, Ohio, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Texas Oncology - Northeast Texas
🇺🇸Tyler, Texas, United States
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
🇺🇸Blacksburg, Virginia, United States
Carbone Cancer Center / University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Institut Gustave Roussy
🇫🇷Villejuif Cedex, Other, France
University of Alberta / Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Istituto Europeo di Oncologia
🇮🇹Milano, Other, Italy
Policlinico Universitario Agostino Gemelli
🇮🇹Rome, Other, Italy
University Health Network, Princess Margaret Hospital
🇨🇦Toronto, Other, Canada
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Other, Spain
L'Institut Catala d'Oncologia
🇪🇸L'Hospitalet de Llobregat, Other, Spain
HM Centro Integral Oncologico Clara Campal
🇪🇸Madrid, Other, Spain
Texas Oncology - Austin Midtown
🇺🇸Austin, Texas, United States
Arizona Oncology Associates, PC - HOPE
🇺🇸Tucson, Arizona, United States
Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Wake Forest Baptist Medical Center / Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States