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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-07220060 is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Argentina, China, Czechia, Japan, Mexico, Slovakia, United Kingdom
EXPERIMENTAL: 1A Monotherapy Escalation Arm 1
PF-07220060 Monotherapy Escalation
DRUG: PF-07220060
CDK4 inhibitorEXPERIMENTAL: 1A Monotherapy Escalation Arm 2
PF-07220060 Monotherapy Escalation
DRUG: PF-07220060
CDK4 inhibitorEXPERIMENTAL: 1A Monotherapy Escalation Arm 3
PF-07220060 Monotherapy Escalation
DRUG: PF-07220060
CDK4 inhibitorEXPERIMENTAL: 1A Monotherapy Escalation Arm 4
PF-07220060 Monotherapy Escalation
DRUG: PF-07220060
CDK4 inhibitorEXPERIMENTAL: 1B Combination Dose Finding Arm 1
PF-07220060 with Letrozole combination Escalation
DRUG: PF-07220060
CDK4 inhibitorEXPERIMENTAL: 1B Combination Dose Finding Arm 2
PF-07220060 with Letrozole Combination Escalation
DRUG: PF-07220060
CDK4 inhibitorEXPERIMENTAL: 1C Combination Dose Finding Arm 1
PF-07220060 with Fulvestrant Combination Escalation
DRUG: PF-07220060
CDK4 inhibitorEXPERIMENTAL: 1C Combination Dose Finding Arm 2
PF-07220060 with Fulvestrant Combination Escalation
DRUG: PF-07220060
CDK4 inhibitorEXPERIMENTAL: 2B Combination Dose Expansion
PF-07220060 with Letrozole Combination Expansion
DRUG: PF-07220060
CDK4 inhibitorEXPERIMENTAL: 2C Combination Dose Expansion
PF-07220060 with fulvestrant Combination Expansion
DRUG: PF-07220060
CDK4 inhibitorEXPERIMENTAL: 1D Monotherapy Food Effect
PF-07220060 Monotherapy Food Effect
DRUG: PF-07220060
CDK4 inhibitorEXPERIMENTAL: 1A Monotherapy Escalation Arm 5
PF-07220060 Monotherapy Escalation
DRUG: PF-07220060
CDK4 inhibitorEXPERIMENTAL: 1F Combination Dose Finding
PF-07220060 with Enzalutamide Escalation
DRUG: PF-07220060
CDK4 inhibitorEXPERIMENTAL: 1E DDI Cohort
PF-07220060 DDI with Midazolam
DRUG: PF-07220060
CDK4 inhibitorDRUG: Midazolam
Benzodiazepine used for DDIEXPERIMENTAL: 2D Combination Dose Expansion
PF-07220060 with enzalutamide Combination Expansion
DRUG: PF-07220060
CDK4 inhibitorEXPERIMENTAL: 2A Combination Dose Expansion
PF-07220060 with fulvestrant combination dose expansion
DRUG: PF-07220060
CDK4 inhibitorEXPERIMENTAL: 2E Combination Dose Expansion
PF-07220060 Monotherapy OR PF-07220060 plus fulvestrant combination therapy
DRUG: PF-07220060
CDK4 inhibitorNumber of participants with dose limiting toxicities in the Dose Escalation Portion
First cycle (28 days) dose limiting toxicities (Parts 1A, 1B, 1C, 1F)
Baseline up to day 28 of Cycle 1.
Incidence of clinically significant AEs
Adverse Events
Weekly during Cycle 1 and 2 and then every 28 days through study completion, up to approximately 24 months; Each cycle is 28 days
Incidence of clinically significant laboratory assessments
safety laboratory abnormalities
Weekly during Cycle 1 and 2 (each cycle is 28 days) and then every 28 days through study completion, up to approximately 24 months
Incidence of clinically significant abnormal vital and ECG parameters
vital signs and heart rate corrected QT interval
Day 1, Day 8, Day 15 of Cycle 1 and starting from Cycle 2, and then every 28 days through study completion, up to approximately 24 months (Each cycle is 28 days)
Food Effect
Maximal Concentration, Time to Maximum Plasma Concentration, Area under the Plasma Concentration (Part 1D)
Day -7 through the end of Cycle 1
DDI
Maximal Concentration, Time to Maximum Plasma Concentration, Area under the Plasma Concentration (Part 1E)
D1 to the end of Cycle 1
Single Dose: Maximal concentration (Cmax) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Single Dose: Time to Maximum Plasma Concentration (Tmax) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Single Dose: Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Time Point Within the Dose Interval (AUClast) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Single Dose: Area Under the Plasma Concentration Versus Time Curve from Time Zero Extrapolated to Infinity (AUCinf) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Time Frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Apparent Oral Plasma Clearance (CL/F) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Single Dose: Apparent Volume of Distribution (Vz/F) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Multiple Dose: Steady State Maximal Concentration (Css,max) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Multiple Dose: Time to Maximum Plasma Concentration at Steady State (Tss,max) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCss,t) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Multiple Dose: Steady State Minimum Plasma Concentration (Css,min) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Multiple Dose: Steady State Apparent Oral Plasma Clearance (CLss/F) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Multiple Dose: Apparent Volume of Distribution at Steady State (Vss/F) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Multiple Dose: Terminal Elimination Half-Life (t1/2) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Multiple Dose: Accumulation Ratio (Rac (AUCss,t /AUCsd,t)) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Tumor Response per RECIST v1.1 and per PCGW3
Per RECIST v1.1 (Part 1 A-E; Part 2B and 2C); per PCWG3 (Part 1F and Part 2D)
baseline up to approximately 24 months
Duration of Response (DOR)
Per RECIST v1.1
baseline up to approximately 24 months
Progression Free Survival (PFS)
PFS per RECIST v.1.1
baseline up to approximately 24 months
Time to Progression (TTP)
TTP per RECIST v1.1
baseline up to approximately 24 months
Clinical Benefit Rate (CBR)
CBR per RECIST v1.1 (Parts 2B, 2C)
baseline up to approximately 24 months
Peak and Trough Concentration of PF-07220060
Peak and trough concentration (Parts 2B, 2C, 2D)
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Peak and trough concentrations of enzalutamide and N-desmethyl enzalutamide
Peak and trough concentrations (Part 2D)
Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Time to first skeletal events
Time to first skeletal events (Part 2D)
Cycle 1 (each cycle is 28 days) to up to approximately 24 months
Quality of life questionnaire
time to functional status deterioration by FACT-P (Part 2D)
Cycle 1 (each cycle is 28 days) to up to approximately 24 months
Radiographic Progression Free survival
Part 2D
Cycle 1 (each cycle is 28 days) up to approximately 24 months
PSA50
Part 1F and 2D
Cycle 1 (each cycle is 28 days) to up to approximately 24 months
337
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: