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.
Important Notice Regarding the Scientific Information You Have Requested
You are being redirected to the scientific presentations section. The information provided here relate to investigational assets. The safety and efficacy of the unapproved assets has not been proven.
Please acknowledge that you understand this before proceeding.
Other or Multiple Cancer Types
PF-07799544 is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Australia, Brazil, Canada, Israel
for more information at clinicaltrials.gov
EXPERIMENTAL: Phase 1a Monotherapy Dose Escalation
Participants will receive PF-07799544
DRUG: PF-07799544
TabletEXPERIMENTAL: Phase 1b Combination Dose Escalation
Participants will receive PF-07799544 and PF-07799933
DRUG: PF-07799544
TabletDRUG: PF-07799933
TabletEXPERIMENTAL: Phase 1b Combination Dose Expansion
Participants will receive PF-07799544 and PF-07799933
DRUG: PF-07799544
TabletDRUG: PF-07799933
TabletPhase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with dose limiting toxicities (DLTs)
DLTs will be evaluated during the first cycle (21 days) as a single agent (phase 1a monotherapy) or in combination with other agents (phase 1b dose escalation)
Cycle 1 (21 days)
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with treatment-emergent adverse events (AEs)
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Baseline to 28 days after last dose of study medication
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in laboratory abnormalities
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Baseline to 28 days after last dose of study treatment
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in vital sign abnormalities
Vital sign abnormalities as characterized by type, frequency, severity, and timing.
Baseline to 28 days after last dose of study treatment
Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in physical exam abnormalities
Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Baseline to 28 days after last dose of study treatment
Phase 1b Dose Expansion: Overall response rate (ORR)
Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors
Baseline to 2 years
Phase 1a monotherapy and Phase 1b combination dose escalation: ORR
ORR as assessed using the RECIST version 1.1.
Baseline to 2 years
Phase 1b Dose Expansion: Number of participants with treatment-emergent adverse events (AEs)
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Baseline to 2 years
Phase 1b Dose Expansion: Number of participants with clinically significant change from baseline in vital sign abnormalities
Vital sign abnormalities as characterized by type, frequency, severity, and timing.
Baseline to 2 years
Phase 1b Dose Expansion: Number of participants with clinically significant change from baseline in laboratory abnormalities
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Baseline to 2 years
Phase 1b Dose Expansion: Duration of Response (Overall and in CNS)
Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors
Baseline to 2 years
Phase 1b Dose Expansion: Intracranial response
Intracranial response by RECIST version 1.1 (for brain metastases)
Baseline to 2 years
Phase 1b Dose Expansion: Progression Free Survival (PFS)
Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors
Baseline to 2 years
PK Parameters: Maximum Observed Concentration (Cmax)
Single dose and multiple dose PK will be calculated as data permits
Baseline to 2 years
PK Parameters: Maximum Plasma Concentration (Tmax)
Single dose and multiple dose PK will be calculated as data permits
Baseline to 2 years
PK Parameters: Area Under Curve (AUC)
Single dose and multiple dose PK will be calculated as data permits
Baseline to 2 years
PK Parameters: terminal elimination half-life (t½)
Singe dose and multiple dose PK will be calculated as data permits
Baseline to 2 years
PK Parameters: Apparent Oral Clearance (CL/F)
Singe dose and multiple dose PK will be calculated as data permits
Baseline to 2 years
PK Parameters: Apparent Volume of Distribution (Vz/F)
Singe dose and multiple dose PK will be calculated as data permits
Baseline to 2 years
124
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.
NCT05538130
Back
