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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
111
Given into the vein (IV; intravenously)
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
...and 8 more locations
Incidence of adverse events (AEs)
To be summarized using descriptive statistics
Time frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Incidence of laboratory abnormalities
To be summarized using descriptive statistics
Time frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Incidence of dose limiting toxicities
To be summarized using descriptive statistics
Time frame: Up to 28 days
Objective response rate (ORR) as assessed by the investigator per RECIST v1.1
ORR is defined as the proportion of subjects achieving a partial response (PR) or complete response (CR).
Time frame: Up to approximately 3 years
Progression-free survival (PFS)
PFS is defined as the time from the start of any study treatment to first documentation of disease progression or to death due to any cause, whichever comes first.
Time frame: Up to approximately 3 years
Overall survival (OS)
OS is defined as the time from the start of any study treatment to the date of death due to any cause.
Time frame: Up to approximately 3 years
Duration of objective response (DOR)
DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause, whichever comes first.
Time frame: Up to approximately 3 years
Area under the concentration-time curve (AUC)
Pharmacokinetic (PK) endpoint
Time frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Time to maximum concentration (Tmax)
PK endpoint
Time frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Maximum concentration (Cmax)
PK endpoint
Time frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Trough concentration (Ctrough)
PK endpoint
Time frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
Incidence of antidrug antibodies (ADA)
Immunogenicity endpoint
Time frame: Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
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