This trial will study SGN-CD47M to find out whether it is an effective treatment for different types of solid tumors and what side effects (unwanted effects) may occur. The study will have two parts. Part A of the study will find out how much SGN-CD47M should be given for treatment and how often. Part B of the study will use the dose found in Part A and look at how safe and effective the treatment is.
This is a dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and antitumor activity of SGN-CD47M in adults with advanced solid tumors. The study will be conducted in 2 parts: Part A - Dose escalation: Up to approximately 25 patients will be treated to evaluate the safety, tolerability, and PK of SGN-CD47M, and to identify the maximum tolerated dose (MTD) and/or optimal dose. Part B - Dose expansion: Up to approximately 180 patients will be treated in expansion cohorts at the MTD or optimal dose to further characterize the safety, PK, and antitumor activity of SGN-CD47M. In eligible patients, standard therapies must have failed, been intolerable, or been considered medically inappropriate by the investigator. If the MTD is not reached in Part A, safety, PK, pharmacodynamic, and biomarker analyses, as well as preliminary antitumor activity, will be used to determine the optimal dose. Patients in Part A may continue on treatment until confirmed progressive disease (PD) or unacceptable toxicity, whichever occurs first. The dose(s) to be examined in Part B will be at or below the MTD and/or the optimal dose determined in Part A.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
SGN-CD47M administered intravenously
Case Western Reserve University / University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Tennessee Oncology-Nashvilee/Sarah Cannon Research Institute
Nashville, Tennessee, United States
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Number of patients with adverse events
Time frame: Up to approximately 24 months
Number of patients with laboratory abnormalities
Time frame: Up to approximately 24 months
Number of patients with dose-limiting toxicities (DLTs)
Time frame: 28 days
Objective response rate (ORR) per RECIST v1.1
Defined as the proportion of patients with CR or PR
Time frame: Up to approximately 2.5 years
ORR per iRECIST
Defined as the proportion of patients with iCR or iPR
Time frame: Up to approximately 2.5 years
Duration of objective response (DOR) per RECIST v1.1
Defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever comes first
Time frame: Up to approximately 2.5 years
DOR per iRECIST
Time frame: Up to approximately 2.5 years
Duration of complete response (CR) per RECIST v1.1
Defined as the time from start of the first documentation of objective tumor response to the first documentation of confirmed tumor progression or to death due to any cause, whichever comes first for the subgroup of patients achieving a CR
Time frame: Up to approximately 2.5 years
Duration of CR per iRECIST
Time frame: Up to approximately 2.5 years
Progression-free survival (PFS) per RECIST v1.1
Defined as the time from start of study treatment to first documentation of disease progression or to death due to any cause, whichever comes first
Time frame: Up to approximately 2.5 years
PFS per iRECIST
Time frame: Up to approximately 2.5 years
Overall survival (OS)
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 4 years
Area under the concentration-time curve (AUC)
Time frame: Up to approximately 24 months
Maximum concentration (Cmax)
Time frame: Up to approximately 24 months
Time to Cmax (Tmax)
Time frame: Up to approximately 24 months
Trough concentration (Ctrough)
Time frame: Up to approximately 24 months
Incidence of antidrug antibodies (ADA)
Time frame: Up to approximately 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.