This clinical trial is studying lymphoma. Lymphoma is a cancer that starts in the blood cells that fight infection. There are several types of lymphoma. This study will enroll people who have classical Hodgkin lymphoma (cHL), peripheral T cell lymphoma (PTCL), or diffuse large B cell lymphoma (DLBCL). This clinical trial uses a drug called PF-08046044/SGN-35C . The study drug is in testing and has not been approved for sale. This is the first time SGN -35C will be used in people. This study will test the safety of SGN-35C in participants with lymphoma. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease. This study will have three parts. Parts A and B of the study will find out the best dose and dosing schedule for SGN-35C. Part C will use the dose found in parts A and B to find out how safe SGN-35C is and if it works to treat select lymphomas.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Given into the vein (IV; intravenously)
City of Hope (City of Hope National Medical Center, City Of Hope Medical Center)
Duarte, California, United States
IP Address: City of Hope Investigational Drug Services(IDS)
Duarte, California, United States
University of California, San Francisco Medical Center
San Francisco, California, United States
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
Coral Gables, Florida, United States
University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach, Florida, United States
Number of participants with adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Time frame: Through 30-37 days after last study treatment, approximately 1 year
Number of participants with laboratory abnormalities
Time frame: Through 30-37 days after last study treatment, approximately 1 year
Number of participants with dose modifications due to AEs
Time frame: Up to approximately 1 year
Number of participants with dose-limiting toxicities (DLTs)
Time frame: Up to 21 days
Number of participants with DLTs by dose level
Time frame: Up to 21 days
Number of participants with antidrug antibodies (ADA)
To be summarized using descriptive statistics
Time frame: Through 30-37 days after last study treatment, approximately 1 year
Area under the concentration time curve (AUC)
To be summarized using descriptive statistics
Time frame: Through 30-37 days after last study treatment, approximately 1 year
Maximum concentration (Cmax)
To be summarized using descriptive statistics
Time frame: Through 30-37 days after last study treatment, approximately 1 year
Time at which the maximum concentration occurs (Tmax)
To be summarized using descriptive statistics
Time frame: Through 30-37 days after last study treatment, approximately 1 year
Apparent terminal half-life (t1/2)
To be summarized using descriptive statistics
Time frame: Through 30-37 days after last study treatment, approximately 1 year
Trough concentration (Ctrough)
To be summarized using descriptive statistics
Time frame: Through 30-37 days after last study treatment, approximately 1 year
Objective response rate (ORR) as assessed by the investigator
A participant is determined to have an objective response if, based on Lugano criteria (Cheson 2014), they achieve a complete response (CR) or partial response (PR) as assessed by the investigator. The ORR is defined as the percentage of participants with an objective response.
Time frame: Up to approximately 1 year
CR rate as assessed by the investigator
CR rate is defined as the proportion of participants with CR.
Time frame: Up to approximately 1 year
Duration of response (DOR)
DOR is defined as the time from the start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per Lugano criteria (Cheson 2014) as assessed by the investigator or to death due to any cause, whichever comes first.
Time frame: Up to approximately 1 year
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Miami, Florida, United States
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...and 23 more locations