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Other or Multiple Cancer Types
PF-07994525 | KAT2 is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Canada
for more information at clinicaltrials.gov
EXPERIMENTAL: Part 1
Monotherapy Dose Expansion
DRUG: PF-07994525
Oral administration
DRUG: Midazolam
Oral administration
EXPERIMENTAL: Part 2
Monotherapy Dose Escalation
DRUG: PF-07994525
Oral administration
Measurable disease based on IMWG criteria as defined by at least 1 of the following: 1. Serum M-protein \>0.5 g/dL by serum protein electrophoresis (SPEP) 2. Urinary M-protein excretion \>200 mg/24 hours by urine protein electrophoresis (UPEP) 3. Serum immunoglobulin Free Light Chain (FLC) ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65) * Participants must be refractory to, or intolerant to, all established therapies known to provide clinical benefit in multiple myeloma that are an appropriate therapeutic option, in the judgement of the investigator. A minimum of 3 prior lines of therapy are required. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Type, incidence and severity of participants with adverse events (AEs)
Type, incidence, severity (graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0), timing, seriousness, and relatedness of adverse events (AEs)
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Type, incidence and severity of participants with laboratory abnormalities
Type, incidence, and severity (graded by NCI CTCAE version 5.0) of laboratory abnormalities
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Number of participants with dose modifications
Frequency of dose modifications (eg, dose delay, treatment interruptions, dose reductions, and treatment discontinuations) due to AEs
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
Occurrence of DLTs as defined by the protocol
Baseline to end of DLT evaluation period
Part 1: Recommended Monotherapy Dose for Expansion (RDE)
RDE will be based on cumulative safety, preliminary antitumor activity and pharmacokinetics findings
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Part 2: Recommended Dose for future development
Safety, and preliminary anti-tumor activity
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Objective response rate (ORR) per International Myeloma Working Group (IMWG) response criteria as determined by investigator.
Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)
Complete response rate (CRR) per International Myeloma Working Group (IMWG) response criteria as determined by investigator.
Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)
Time to response (TTR) per IMWG as determined by investigator
Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)
Duration of response (DOR) per IMWG as determined by investigator
Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)
Duration of complete response (DOCR) per IMWG as determined by investigator
Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)
Progression-free survival (PFS) per IMWG as determined by investigator
Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)
Overall survival (OS)
Baseline until the date of the first documentation of disease progression, death, or start of new anticancer therapy (approximately 2 years)
Single, Multiple Dose and food effect: Maximum Observed Concentration (Cmax)
Pharmacokinetic (PK) assessments for PF-07994525
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Single, Multiple Dose and food effect: Time to Maximum concentration (Tmax)
Pharmacokinetic (PK) assessments for PF-07994525
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Single, Multiple Dose and food effect: AUC from time zero to time of last measurable concentration (AUClast)
Pharmacokinetic (PK) assessments for PF-07994525
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Single Dose and food effect: Terminal Elimination half-life (t1/2) as data permit
Pharmacokinetic (PK) assessments for PF-07994525
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Single Dose and food effect: AUC versus time curve from time 0 extrapolated to infinity (AUCinf) as data permit
Pharmacokinetic (PK) assessments for PF-07994525
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Single, Multiple Dose and food effect: apparent clearance of drug (CL/F) as data permit
Pharmacokinetic (PK) assessments for PF-07994525
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Single, Multiple Dose and food effect: Apparent volume of distribution during terminal phase (Vz/F) as data permit
Pharmacokinetic (PK) assessments for PF-07994525
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Multiple Dose: AUC at steady state over the dosing interval (AUCtau) as data permit
Pharmacokinetic (PK) assessments for PF-07994525
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Multiple Dose: Cmin as data permit
Pharmacokinetic (PK) assessments for PF-07994525
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Multiple Dose: Accumulation ratio (Rac) as data permit
Pharmacokinetic (PK) assessments for PF-07994525
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
AUC from time zero to time of last measurable concentration (AUClast)
PK parameters of CYP3A4 probe substrate midazolam with and without PF-07994525
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Time to Maximum concentration (Tmax)
PK parameters of CYP3A4 probe substrate midazolam with and without PF-07994525
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
Maximum Observed Concentration (Cmax)
PK parameters of CYP3A4 probe substrate midazolam with and without PF-07994525
From the first day through 30-37 days after the last study treatment, up to approximately 2 years
120
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.
NCT07426757
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