A Study to Learn About PF-07921585 Alone or With Other Anti-cancer Medicines in People With Cancer
NCT Number: NCT06580938
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Non Small Cell Lung Cancer|Bladder Cancer|Renal Cell Carcinoma|Melanoma|Head and Neck Cancer|Colorectal Cancer
Interventions: BIOLOGICAL: PF-07921585|BIOLOGICAL: Sasanlimab
Sponsor: Pfizer
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 190
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2028-11-15

Summary:
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-07921585) in people with cancer that has advanced or spread to other parts of the body.

This study is seeking participants who have any of the following cancer types:

* non-small cell lung cancer
* colorectal cancer
* bladder cancer
* melanoma (a type of skin cancer)
* kidney cancer
* head and neck cancer Participants will receive the study medicine PF-07921585 alone or in combination with another study medicine called sasanlimab at the study clinic.

PF-07921585 will be given as an infusion into a vein or as shots under the skin, once every 3 weeks. Sasanlimab will be given as shots under the skin, also once every 3 weeks.

The experiences of participants receiving the study medicine will be studied to help see if the study medicine is safe and effective. Participants may receive study medicine for up to 2 years, depending on how the cancer responds to the study treatment. Participants may continue receiving study medicine after 2 years if there are any benefits from the study treatment. Participants will attend visits once every 3 weeks with the first 9 weeks having more frequent visits, to check the safety of the study treatment.

Primary Outcome Measures: Number of Participants With Dose-Limiting Toxicity (DLT) (Parts 1 and 2), Specific adverse events occurring during the first 21 days of study medication and considered at least possibly-related to study medication, Baseline up to Cycle 2 (each cycle is 21 days)|Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs (Parts 1 and 2), AEs are any untoward medical occurrence in a participant who received study drug. Serious adverse event (SAE) are AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 or 90 days after last dose that were absent before treatment or that worsened relative to pretreatment state., Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab|Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities (Parts 1 and 2), Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing., Baseline up to 28 days after the last dose of PF-07921585 or after 90 days after the last dose of sasanlimab|Objective Response Rate - Percentage of Participants With Objective Response (Part 3), Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors 1. 1 (RECIST 1.1).

CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions., Date of first dose up to 2 years
Secondary Outcome Measures: Number of Participants with Treatment emergent Adverse Events (AEs) and Serious AEs (Part 3), AEs are any untoward medical occurrence in a participant who received study drug. Serious adverse event (SAE) are AEs resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 or 90 days after last dose that were absent before treatment or that worsened relative to pretreatment state., Baseline up to 28 days after the last dose of PF-07921585 and 90 days after the last dose of sasanlimab|Objective Response Rate-Percentage of Participants with objective response (Parts 1 and 2), Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors 1. 1 (RECIST 1.1).

CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions., Date of first dose up to 2 years|Duration of response (DOR)-Parts 1-3, Time in weeks or months from the first documentation of objective tumor response that is subsequently confirmed to objective tumor progression or death due to any cause., Date of first dose up to 2 years|Disease control rate (DCR)-Parts 1-3, DCR is defined as the percent of participants with a confirmed complete response (CR), partial response (PR) or stable disease (SD) according to RECIST 1.1, at 6 weeks., Date of first dose up to 2 years|Progression Free survival (PFS)-Parts 1-3, Time in weeks or months from first dose to first documentation of objective tumor progression per RECIST 1.1 or death due to any cause., Date of first dose until disease progression or death, up to a maximum of 4 years|Overall Survival (OS)-Part 3, Time in weeks or months from the start of study treatment to date of death due to any cause., Date of first dose until death, up to a maximum of 4 years|Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax)-PF-07921585, Single dose PK of PF-07921585 as monotherapy (Part 1) and in combination with sansalimab (Parts 2-3) will be calculated. Additional parameters may be calculated if data permits, At specific timepoints from Cycle 1 day 1 up to 2 years|Pharmacokinetic Parameters: Time to Reach Maximum Observed Plasma Concentration (Tmax ss)-PF-07921585, Multiple dose PK of PF-07921585 as monotherapy (Part 1) and in combination with sasanlimab (Parts 2-3) will be calculated. Additional parameters may be calculated if data permits, At specific timepoints from Cycle 1 day 1 up to 2 years|Pharmacokinetic Parameters: Area under the curve (AUCt)-PF-07921585, Single dose PK of PF-07921585 as monotherapy (Part 1) and in combination with sasanlimab (Parts 2-3) will be calculated. Additional parameters may be calculated if data permits, At specific timepoints from Cycle 1 day 1 up to 2 years|Pharmacokinetic Parameters: Area under the curve (AUCt ss)-PF-07921585, Multiple dose PK of PF-07921585 as monotherapy (Part 1) and in combination with sasanlimab (Parts 2-3) will be calculated. Additional parameters may be calculated if data permits, At specific timepoints from Cycle 1 day 1 up to 2 years|Pharmacokinetic Parameters: Cmax (maximum drug concentration in the body)-PF-07921585, Single dose PK of PF-07921585 as monotherapy will be calculated. Additional parameters may be calculated if data permits, At specific timepoints from Cycle 1 day 1 up to 2 years|Pharmacokinetic Parameters: Cmax ss (maximum drug concentration in the body)-PF-07921585, Multiple dose PK of PF-07921585 as monotherapy (Part 1) and in combination with sasanlimab (Parts 2-3) will be calculated. Additional parameters may be calculated if data permits, At specific timepoints from Cycle 1 day 1 up to 2 years|Percentage of Participants With Positive PF-07921585 Anti-Drug Antibody (ADA), Percentage of ADA positive participants by dose level (Parts 1-3), At specific timepoints from Cycle 1 day 1 up to 2 years|Percentage of Participants With Positive PF-07921585 neutralizing antibodies (Nab), Percentage of Nab positive participants by dose level (Parts 1-3), At specific timepoints from Cycle 1 Day 1 up to 2 years|Incidence and titer of PF-07921585 ADA and Nab, Parts 1-3, At specific timepoints from Cycle 1 Day 1 up to 2 years|Pharmacokinetic Parameters: C through-Sasanlimab, PK of sasanlimab (Parts 2 and 3), At specific timepoints, predose, from Cycle 1 day 1 up to 2 years|Percentage of Participants With Positive sasanlimab Anti-Drug Antibody (ADA), Percentage of ADA positive participants by dose level (Parts 2-3), At specific timepoints from Cycle 1 day 1 up to 2 years|Percentage of Participants With Positive sasanlimab neutralizing antibodies (Nab), Percentage of Nab positive participants by dose level (Parts 2-3), At specific timepoints from Cycle 1 Day 1 up to 2 years|Incidence and titer of sasanlimab ADA and Nab, Parts 2-3, At specific timepoints from Cycle 1 Day 1 up to 2 years