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PF-08032562 | KAT6/7 is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States
for more information at clinicaltrials.gov
EXPERIMENTAL: Part 1 Dose Escalation Cohort 1A
PF-08032562 monotherapy dose escalation for participants with advanced or metastatic BC or CRC, at different doses and/or schedules of the study drug
DRUG: PF-08032562
Taken by mouth (PO)
EXPERIMENTAL: Part 1 Dose Escalation Cohort 1B
Combination (PF-08032562 + fulvestrant) dose escalation for participants with advanced or metastatic BC, at different doses and/or schedules of the study drug
DRUG: PF-08032562
Taken by mouth (PO)
DRUG: Fulvestrant
Selective Estrogen Receptor Degrader (SERD)
EXPERIMENTAL: Part 1 Dose Escalation Cohort 1C
Combination (PF-08032562 + cetuximab) dose escalation for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug
DRUG: PF-08032562
Taken by mouth (PO)
DRUG: Cetuximab
Monoclonal antibody (EGFR inhibitor)
EXPERIMENTAL: Part 1 Dose Escalation Cohort 1D
Combination (PF-08032562 + \[FOLFOX + bevacizumab\]) dose escalation for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug
DRUG: PF-08032562
Taken by mouth (PO)
DRUG: Fluorouracil
Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
DRUG: Oxaliplatin
Part of FOLFOX chemotherapy regimen platinum based compound (alkylating agent)
DRUG: Leucovorin
Part of FOLFOX chemotherapy regimen (folic acid analog)
DRUG: Bevacizumab
Monoclonal antibody (VEG-F inhibitor)
EXPERIMENTAL: Part 2 Dose Expansion Cohort 2A
Combination (PF-08032562 + fulvestrant) dose expansion for participants with advanced or metastatic BC, at different doses and/or schedules of the study drug
DRUG: PF-08032562
Taken by mouth (PO)
DRUG: Fulvestrant
Selective Estrogen Receptor Degrader (SERD)
EXPERIMENTAL: Part 2 Dose Expansion Cohort 2B
PF-08032562 monotherapy or combination (PF-08032562 + cetuximab) dose expansion for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug
DRUG: PF-08032562
Taken by mouth (PO)
DRUG: Cetuximab
Monoclonal antibody (EGFR inhibitor)
EXPERIMENTAL: Part 2 Dose Expansion Cohort 2C
Combination (PF-08032562 + \[FOLFOX + bevacizumab\]) dose expansion for participants with advanced or metastatic CRC, at different doses and/or schedules of the study drug
DRUG: PF-08032562
Taken by mouth (PO)
DRUG: Fluorouracil
Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog)
DRUG: Oxaliplatin
Part of FOLFOX chemotherapy regimen platinum based compound (alkylating agent)
DRUG: Leucovorin
Part of FOLFOX chemotherapy regimen (folic acid analog)
DRUG: Bevacizumab
Monoclonal antibody (VEG-F inhibitor)
Part 1 (Dose Escalation): Number of participants with Dose-Limiting Toxicities (DLT)
Any adverse events that are attributable to one, the other, or both study treatments, occurring in the DLT observation period are considered DLTs, excluding toxicities clearly due to underlying disease or extraneous causes.
Baseline up to 28 days
Part 1 (Dose Escalation): Number of participants with laboratory abnormalities
Number of participants with laboratory test abnormalities.
From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first
Part 1 (Dose Escalation): Incidence of Adverse Events (AEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first
Part 2 (Dose Expansion): Objective Response Rate (ORR)
ORR defined as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years)
Part 1 & Part 2: Maximum Observed Serum Concentration (Cmax)
Evaluate the single and multiple dose PK of PF-08032562 as monotherapy, or in combination with other anti-tumor agents.
Baseline through end of Cycle 1 (each cycle is 28 days)
Part 1 & Part 2: Time to Reach Maximum Observed Serum Concentration (Tmax)
Evaluate the single and multiple dose PK of PF-08032562 as monotherapy, or in combination with other anti-tumor agents.
Baseline through end of Cycle 1 (each cycle is 28 days)
Part 1: Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration (AUClast)
Evaluate the single and multiple dose PK of PF-08032562 as monotherapy, or in combination with other anti-tumor agents.
Baseline through end of Cycle 1 (each cycle is 28 days)
Part 1: Effect of Food on Cmax
Evaluate the effect of food on Cmax of PF-08032562 as monotherapy
Baseline through end of Cycle 1 (each cycle is 28 days)
Part 1: Effect of Food on Tmax
Evaluate the effect of food on Tmax of PF-08032562 as monotherapy
Baseline through end of Cycle 1 (each cycle is 28 days)
Part 1: Effect of Food on AUClast
Evaluate the effect of food on AUClast of PF-08032562 as monotherapy
Baseline through end of Cycle 1 (each cycle is 28 days)
Part 1: Percent change of immune cells within tumors based on immunohistochemistry assessment
Evaluate the single and multiple dose pharmacodynamics of PF-08032562 as monotherapy, or in combination with other anti-tumor agents. This measure will assess change in the concentration of immune cell-related cytokines and chemokines as potential pharmacodynamic effects of PF-08032562 using Immunohistochemistry (IHC) assays.
Baseline through end of Cycle 1 (each cycle is 28 days)
Part 2 (Dose Expansion): Number of participants with laboratory abnormalities
Number of participants with laboratory test abnormalities.
From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first
Part 2 (Dose Expansion): Incidence of Adverse Events (AEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.
From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first
Part 1 & Part 2: Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
ORR is defined as the percentage of participants in the analysis population having a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST v1.1.
Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years)
Part 1 & Part 2: Disease Control Rate (DCR) as per RECIST v1.1
DCR is defined as the proportion of participants with CR or PR with confirmation, or Stable Disease (SD) per RECIST version 1.1.
Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years)
Part 1 & Part 2: Clinical Benefit Rate (CBR) as per RECIST v1.1
CBR is defined as the percentage of participants with a best overall response of CR or PR at any time before Progressive Disease (PD), or non-CR/non-PD or SD for at least 24 weeks from start date of treatment and prior to PD, relative to the appropriate analysis set.
Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years)
Part 1 & Part 2: Duration of Response (DOR) as per RECIST v1.1
DOR is defined as the time from first documentation of CR or PR to date of first documentation of PD or death due to any cause.
Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years)
Part 1 & Part 2: Progression-Free Survival (PFS) as per RECIST v1.1
PFS is defined as time from start date of treatment to the date of first documentation of PD or death due to any cause.
Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years)
Part 1 & Part 2: Time to Response (TTR) as per RECIST v1.1
TTR is defined as the time from start date of treatment to first documentation of CR or PR.
Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion (approximately 2 years)
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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.
NCT07318805
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