This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with pembrolizumab in participants with solid tumors. It will also study the side effects of this drug. A side effect is anything a drug does to your body besides treating your disease. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have five parts. Parts A and B of the study will find out how much PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V with pembrolizumab to find out how safe this combination is and if it works to treat solid tumor cancers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
714
Given into the vein (IV; intravenously)
200 mg once every 3 weeks given into the vein (IV; intravenously)
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGUniversity of Alabama at Birmingham, IDS Pharmacy
Birmingham, Alabama, United States
RECRUITINGUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGUniversity of Alabama at Birmingham
Birmingham, Alabama, United States
Number of participants with adverse events (AEs)
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.
Time frame: Through approximately 90 days after last study treatment; up to 3 years
Number of participants with laboratory abnormalities
Time frame: Through approximately 90 days after last study treatment; up to 3 years
Number of participants with dose-limiting toxicities (DLTs)
Time frame: Through the first cycle of study treatment; approximately 1 month
Number of participants with DLTs by dose level
Time frame: Through the first cycle of study treatment; approximately 1 month
Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by investigator assessment
The proportion of participants with a partial response (PR) or complete response (CR) which is subsequently confirmed per RECIST v1.1 as assessed by the investigator.
Time frame: Up to approximately 3 years
Duration of objective response (DOR) per RECIST v1.1 by investigator assessment
The time from the start of the first documentation of objective tumor response (CR or PR that is subsequently confirmed) to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or to death due to any cause.
Time frame: Up to approximately 3 years
Progression-free survival (PFS) per RECIST v1.1 by investigator assessment
The time from the start of study treatment to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or death due to any cause.
Time frame: Up to approximately 3 years
Overall survival (OS)
The time from the start of study treatment to death due to any cause.
Time frame: Up to approximately 3 years
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; up to approximately 3 years
PK parameter - Maximum concentration (Cmax)
To be summarized using descriptive statistics
Time frame: Through 30-37 days after last study treatment; up to approximately 3 years
PK parameter - Trough concentration (Ctrough)
To be summarized using descriptive statistics
Time frame: Through 30-37 days after last study treatment; up to approximately 3 years
Incidence of anti-drug antibodies (ADAs)
To be summarized using descriptive statistics
Time frame: Through 30-37 days after last study treatment; up to approximately 3 years
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Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California, United States
RECRUITINGUC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, United States
RECRUITINGUniversity of California Davis Comprehensive Cancer Center
Sacramento, California, United States
RECRUITINGUniversity of California, Davis Medical Center
Sacramento, California, United States
RECRUITINGUniversity of Iowa
Iowa City, Iowa, United States
RECRUITINGKarmanos Cancer Institute
Detroit, Michigan, United States
RECRUITING...and 52 more locations