A Study of SGN-CD228A in Advanced Solid Tumors
- Conditions
- Cutaneous MelanomaPleural MesotheliomaHER2 Negative Breast NeoplasmsNon-small Cell Lung CancerColorectal CancerPancreatic Ductal Adenocarcinoma
- Interventions
- Registration Number
- NCT04042480
- Lead Sponsor
- Seagen Inc.
- Brief Summary
This trial will study SGN-CD228A to find out whether it is an effective treatment for different kinds of cancer. It will also look at what side effects (unwanted effects) may occur. The study will have two parts. Part 1 of the study will find out how much SGN-CD228A should be given for treatment and how often. Part 2 of the study will use the dose found in Part 1 and look at how safe and effective the treatment is.
- Detailed Description
This study is designed to evaluate the safety, tolerability, PK, and antitumor activity of SGN-CD228A in select advanced solid tumors. The study will include dose escalation and dose expansion, with multiple disease-specific expansion cohorts.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 88
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SGN-CD228A SGN-CD228A SGN-CD228A monotherapy
- Primary Outcome Measures
Name Time Method Number of participants with adverse events Up to approximately 3.5 years Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Number of participants with laboratory abnormalities Up to approximately 3.5 years Number of participants with dose limiting toxicities Up to approximately 3.5 years
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Up to approximately 3.5 years Defined as the time from the start of any study treatment to the date of death due to any cause.
Best response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Up to approximately 3.5 years Duration of objective response (DOR) Up to approximately 3.5 years Defined as the time from start of the first documentation of objective tumor response (complete response \[CR\] or partial response \[PR\]) to the first documentation of confirm tumor progression or death due to any cause, whichever comes first.
Best response per modified RECIST (mRECIST) (participants with pleural mesothelioma only) Up to approximately 3.5 years Duration of complete response Up to approximately 3.5 years Defined as the 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.
Maximum concentration (Cmax) of antibody-conjugated monomethylauristatin E (acMMAE) Up to approximately 3.5 years Ctrough of total antibody Up to approximately 3.5 years Objective response rate (ORR) Up to approximately 3.5 years A participant is determined to have an OR if they achieve a complete response (CR) or partial response (PR) after initiation of study treatment and at or prior to the end-of-treatment disease assessment.
Progression-free survival (PFS) Up to approximately 3.5 years Defined as the time from the start of study treatment to first documentation of disease progression or death due to any cause, whichever comes first.
Cmax of free MMAE Up to approximately 3.5 years Cmax of total antibody Up to approximately 3.5 years Time to maximum concentration (Tmax) of acMMAE Up to approximately 3.5 years Tmax of free MMAE Up to approximately 3.5 years Area under the plasma concentration-time curve from time 0 to the last available [AUC (0-last)] of acMMAE Up to approximately 3.5 years AUC(0-last) of total antibody Up to approximately 3.5 years Incidence of anti-drug antibodies (ADA) Up to approximately 3.5 years Tmax of total antibody Up to approximately 3.5 years Trough concentration (Ctrough) of acMMAE Up to approximately 3.5 years Ctrough of free MMAE Up to approximately 3.5 years AUC(0-last) of free MMAE Up to approximately 3.5 years
Trial Locations
- Locations (14)
The Angeles Clinic and Research Institute
🇺🇸Los Angeles, California, United States
MD Anderson Cancer Center / University of Texas
🇺🇸Houston, Texas, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Case Western Reserve University / University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Sanford Cancer Center
🇺🇸Sioux Falls, South Dakota, United States
The Royal Marsden Hospital (Surrey)
🇬🇧Sutton, United Kingdom
Institut Gustave Roussy
🇫🇷Villejuif Cedex, France
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Wake Forest Baptist Medical Center / Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
University of Pittsburgh Medical Center (UPMC)/Hillman Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
South Texas Accelerated Research Therapeutics
🇺🇸San Antonio, Texas, United States
Istituto Europeo di Oncologia
🇮🇹Milano, Italy
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Oregon Health and Science University
🇺🇸Portland, Oregon, United States