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.
PF-06940434 is an investigational compound. Its safety and efficacy have not been established.
Active Not-enrolling
United States, Australia, Korea, Republic of, Slovakia, Taiwan
for more information at clinicaltrials.gov
EXPERIMENTAL: Dose Escalation
Single Agent Dose Escalation
DRUG: PF-06940434
PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluatedEXPERIMENTAL: Dose Finding Anti-PD-1 Combination 1
Part 1B PF-06940434 plus anti-PD-1
DRUG: PF-06940434
PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluatedDRUG: PF-06801591
PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.EXPERIMENTAL: Dose Expansion Arm A
PF-06940434 with anti-PD-1 in SCCHN
DRUG: PF-06940434
PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluatedDRUG: PF-06801591
PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.EXPERIMENTAL: Dose Expansion Arm B
PF-06940434 with anti-PD-1 in RCC
DRUG: PF-06940434
PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluatedDRUG: PF-06801591
PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.EXPERIMENTAL: Dose Expansion, Arm C
PF-06940434 with anti-PD-1 (both Q3W)
DRUG: PF-06940434
PF-06940434 is given intravenously (IV) every 2 or 4 weeks in a 28 day cycle or every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluatedDRUG: PF-06801591
PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle or Day 1 of each 21 day cycle.Number of participants with Dose-limiting toxicities (DLT) for Dose Escalation and Dose Finding
Baseline up to 28 Days (Cycle 1)
Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
Baseline up to approximately 24 months
Number of Participants With Adverse Events (AEs) According to Severity
Baseline up to approximately 24 months
Number of Participants With Adverse Events (AEs) According to Seriousness
Baseline up to up to approximately 24 months
Number of Participants With Adverse Events (AEs) by Relationship
Baseline up to approximately 24 months
Progression-Free Survival (PFS) for Dose Expansion
The period from study entry until disease progression, death or date of last contact.
Baseline up to 24 Months
Objective Response Rate - Percentage of Participants With Objective Response in Dose Expansion
Baseline up to 24 months
Duration of Response (DR) for Dose Expansion
Baseline up to 24 Months
PF-06940434 after multiple doses PK parameters (Cmax).
Maximum observed plasma concentration of PF-06940434.
Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434.
Time zero extrapolated to the last quantifiable time point prior to the next dose.
Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Systemic Clearance (CL)
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Volume of Distribution (Vd)
Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Incidence and titers of anti-drug antibodies (ADA) against PF-06940434.
Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
Incidence and titers of neutralizing antibodies (NAb) against PF-06940434.
Titers of neutralizing antibodies (NAb) against PF-06940434.
Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days).
PK parameters of PF-06940434 and PF-06801591 (Cmax).
Maximum observed plasma concentration after multiple doses of PF-06940434 and PD-1 (PF-06801591).
Pre-dose on Cycle 1 Day 1 and on day 15 of Cycle 1; Day 1 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days)
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434 and PF-06801591.
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434 and PF-06801591.
Pre-dose on Cycle 1 Day 1 and on day 15 of Cycle 1; Day 1 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (each cycle is 28 days)
Characterize the multiple dose PK of PF-06940434 following intravenous administration in combination with PF-06801591.
Maximum observed plasma concentration of PF-06940434.
Cycle 4 Day 1 (each cycle is 28 days)
Area under the curve from time zero extrapolated to the last quantifiable dose of PF-06940434.
Time zero extrapolated to the last quantifiable time point prior to the next dose.
Cycle 4 Day 1 (each cycle is 28 days)
Number of participants with increased T-cells after PF-06940434 treatment.
Pre-dose on Day 1 of Cycle 1; pre-dose on Day 1 of Cycles 2 and 3 (each cycle is 28 days)
Progression-Free Survival (PFS) for Dose Expansion
The period from study entry until disease progression, death or date of last contact.
Baseline to measured progression (up to approximately 24 months)
Duration of Response (DR)
Baseline up to approximately 24 Months
Number of Participants With Objective Response for Dose Expansion portion
Baseline up to 24 months
Disease Control Rate (DCR)
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.
Every 8 weeks from the time of enrollment up to 2 years
Trough concentrations of PF-06940434 and PF-06801591 in Dose Expansion
Day 1 of Cycle 1 though 4, Day 1 of every 2 Cycles starting from Cycle 5 up to 24 months (each cycle is 28 days). For Part 2 Cohort 3, Day 1 of Every Cycle (each cycle is 21 days)
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Pre-dose on Cycle 1 Day 1 and on days 3, 8, and 15 of Cycle 1; Day 1 and Day 15 of Cycles 2 and 3; Days 1, 3, 8, and 15 of Cycle 4 and Pre-dose on Day 1 of every cycle thereafter and at end of treatment (up to 24 Months) [each cycle is 28 days]
Incidence and titers of anti-drug antibodies (ADA) against PF-06801591 in Dose Finding and Dose Expansion
Incidence and titers of anti-drug antibodies (ADA) against PF-06801591.
Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (up to 24 Months) [each cycle is 28 days].
Incidence and titers of neutralizing antibodies (NAb) against PF-06801591 in Dose Finding and Dose Expansion.
Incidence and titers of neutralizing antibodies (NAb) against PF-06801591.
Pre-dose on Days 1 and 15 of Cycle 1, pre-dose on Day 1 of Cycles 2 and 3, pre-dose on Day 1 of Cycle 4, pre-dose on Day 1 of every cycle thereafter and at end of treatment (up to 24 Months) [each cycle is 28 days].
Overall Survival
The period from study entry until death or date of last contact (24 months)
From baseline to up to 2 years after last dose of study drug
85
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.
NCT04152018
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