The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Sasanlimab is an investigational compound. Its safety and efficacy have not been established.
Active Not-enrolling
China, Japan, Korea, Republic of, Russian Federation, Taiwan, Ukraine
EXPERIMENTAL: Arm A1 (Phase 1b)
DRUG: PF-06801591
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PDL1/ PD-L2.
EXPERIMENTAL: Arm B1 (Phase 1b)
DRUG: PF-06801591
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PDL1/ PD-L2.
EXPERIMENTAL: Arm A2 (Phase 2)
DRUG: PF-06801591
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PDL1/ PD-L2.
EXPERIMENTAL: Arm B2 (Phase 2)
DRUG: PF-06801591
A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PDL1/ PD-L2.
Phase 1b: Number of Participants With Dose-Limiting Toxicities (DLT)
This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with first line (1L) and second line (2L) non-small cell lung cancer (NSCLC) (Phase 2). For the Phase 1b, any of the following AEs occurring during the DLT observation period (the first cycle of treatment) which were attributable to the investigational product were classified as DLTs: Grade 5 AE not clearly due to the underlying disease or extraneous causes; Hematologic toxicity; Non-Hematologic Toxicity; Delay of ≥ 3 weeks in receiving the next scheduled administration due to persisting treatment-related toxicities.
Phase 1b: at the end of cycle 1 (28 days) for the PF-06801591 300 mg SC Q4W arms, and (42 days) for the PF-06801591 600 mg SC Q6W arms
Phase 2: AUCτ of PF-06801591 at Steady State
This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). AUCτ is area under the plasma concentration-time profile from time zero to the next dose (at steady state, starting at Week 12). (τ = X days, where X = 28 days for Q4W regimen and 42 days for Q6W regimen)
Phase 2: Cycle 4 Day 1, 8, 15, 22 and Cycle 5 Day 1 for the PF-06801591 300 mg SC Q4W arm, and Cycle 3 Day 1, 8, 15, 29 and Cycle 4 Day 1 for the PF-06801591 600 mg SC Q6W arm
Phase 2: Ctrough of PF-06801591 at Steady State, at Week 12
This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). Steady state Ctrough is pre-dose concentration following multiple dosing at steady state (Week 12)
Phase 2: Cycle 4 Day 1 for the PF-06801591 300 mg SC Q4W arm, and Cycle 3 Day 1 for the PF-06801591 600 mg SC Q6W arm
Number of Participants With Treatment-Emergent Adverse Events
This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Phase 1b/2: On-treatment period is defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day).
Number of Participants With Laboratory Abnormalities
Laboratory results were classified according to the NCI-CTCAE criteria version 5.0. Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care (ADL); Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Number of participants with Grade 1 to Grade 4 laboratory abnormalities were reported.
Phase 1b/2: On-treatment period is defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day).
Pharmacokinetic Parameters: AUCτ After First Dose
This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). AUCτ is area under the plasma concentration-time profile from time zero to the next dose (after single dose). (τ = X days, where X = 28 days for Q4W regimen and 42 days for Q6W regimen)
Phase 1b/2: For the PF-06801591 300 mg SC Q4W arms, Cycle 1 Day 1, 8, 15, 22, Cycle 2 Day 1; for the PF-06801591 600 mg SC Q6W arms, Cycle 1 Day 1, 8, 15, 29, Cycle 2 Day 1
Pharmacokinetic Parameters: Ctrough After First Dose
This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). Ctrough is pre-dose concentration after single dose (first dose).
Phase 1b/2: Cycle 2 Day 1 for all Arms
Pharmacokinetic Parameters: Ctrough at Steady State
This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). Steady state Ctrough is pre-dose concentration following multiple dosing at steady state (Week 12)
Phase 1b/2: For the PF-06801591 300 mg SC Q4W arms, Day 1 of Cycle 4; for the PF-06801591 600 mg SC Q6W arms, Day 1 of Cycle 3
Number of Participants With Treatment-Induced Anti-Drug Antibody (ADA) /Neutralizing Antibodies (NAb)
This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). Treatment-induced ADA = Baseline ADA titer was missing or negative and participant had ≥1 post-treatment positive ADA titer (ADA titer greater than or equal to 99 with assay cut-point of 1.09). Treatment-induced NAb = Baseline NAb titer was missing or negative or ADA-negative and participant had ≥1 post-treatment positive NAb titer.
Phase 1b/2: Day 1 of Cycle 1, 2, 3, 4, 6, 8, 10 and end of treatment (EOT) for the PF-06801591 300 mg SC Q4W arms; Day 1 of Cycle 1, 2, 3, 4, 5, 7 and EOT for the PF-06801591 600 mg SC Q6W arms
Number of Participants With Objective Response (OR)
This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). OR was defined as confirmed best overall response (BOR) of complete response (CR) or partial response (PR) according to RECIST v1.1. Complete Response (CR): Complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \
Phase 1b/2: Up to 30 months
Time to Response (TTR)
This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). TTR was defined for participants with confirmed objective response (CR or PR) as the time from the 'start date' to the date of first documentation of objective tumor response which is subsequently confirmed.
Phase 1b/2: Up to 30 months
Number of Participants With Objective Response (Complete Response + Partial Response) Reported by Baseline Programmed Death-Ligand 1 (PD-L1) Status (High, Low, and Unknown)
This study included Asian participants with advanced solid tumors (Phase 1b) and global participants with 1L and 2L NSCLC (Phase 2). OR was defined as confirmed BOR of CR or PR according to RECIST v1.1. CR: Complete disappearance of all target lesions with the exception of nodal disease. All target nodes must decrease to normal size (short axis \
Phase 1b/2: Baseline up to 30 months
155
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT04181788
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