This clinical trial is studying lymphoma. Lymphoma is a cancer that starts in the blood cells that fight infections. There are several types of lymphoma. This study will enroll people who have lymphoma, such as classical Hodgkin lymphoma, peripheral T-cell lymphoma including systemic anaplastic large cell lymphoma, diffuse large B-cell lymphoma, or some types of primary cutaneous lymphoma. This clinical trial uses a drug called PF-08046045/SGN-35T. The study drug is in testing and has not been approved for sale. This is the first time PF-08046045 will be used in people. The study drug will be given as an infusion through a vein. This study will test the safety of PF-08046045 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 PF-08046045. Part C will use the dose found in parts A and B to find out how safe PF-08046045 is and if it works to treat select lymphomas.
This is a phase 1, open-label, multicenter study designed to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of PF-08046045/SGN-35T in adults with select relapsed/refractory lymphomas. PF-08046045 is a CD30-directed antibody-drug conjugate and will be studied in patients with lymphomas expressing CD30.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Given into the vein (IV; intravenously)
Stanford Cancer Center / Blood and Marrow Transplant Program
Palo Alto, California, United States
University of Miami Hospital and Clinics - Lennar
Coral Gables, Florida, United States
University of Miami Hospital and Clinics
Miami, Florida, United States
University of Miami
Miami, Florida, United States
MSK Basking Ridge
Basking Ridge, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
MSK Monmouth.
Middletown, New Jersey, United States
MSK Bergen.
Montvale, New Jersey, United States
Hackensack University Medical Center (From Road)
Paramus, New Jersey, United States
MSK Commack.
Commack, New York, United States
...and 7 more locations
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
Pharmacokinetic (PK) parameter - 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
PK parameter - Maximum concentration (Cmax)
To be summarized using descriptive statistics
Time frame: Through 30-37 days after last study treatment, approximately 1 year
PK parameter - Time to Cmax (Tmax)
To be summarized using descriptive statistics
Time frame: Through 30-37 days after last study treatment, approximately 1 year
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
Objective response rate (ORR) as assessed by the investigator
A subject is determined to have an objective response if, based on disease-specific assessment criteria, 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
Complete response (CR) rate as assessed by the investigator
CR rate is defined as the percentage of subjects 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 disease-specific assessment criteria as assessed by the investigator or to death due to any cause, whichever comes first.
Time frame: Up to approximately 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.