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PF-07994525

Phase 1

Advanced Malignancies | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Jun 1, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07426757An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced CancersPHASE1 RECRUITING 120 — — May 15, 2026Jul 10, 2030Jun 1, 20264 United States
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Study Endpoints
Primary Endpoints
Type, incidence and severity of participants with adverse events (AEs)
From the first day through 30-37 days after the last study treatment, up to approximately 2 years

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)

Type, incidence and severity of participants with laboratory abnormalities
From the first day through 30-37 days after the last study treatment, up to approximately 2 years

Type, incidence, and severity (graded by NCI CTCAE version 5.0) of laboratory abnormalities

Number of participants with dose modifications
From the first day through 30-37 days after the last study treatment, up to approximately 2 years

Frequency of dose modifications (eg, dose delay, treatment interruptions, dose reductions, and treatment discontinuations) due to AEs

Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)
Baseline to end of DLT evaluation period

Occurrence of DLTs as defined by the protocol

Part 1: Recommended Monotherapy Dose for Expansion (RDE)
From the first day through 30-37 days after the last study treatment, up to approximately 2 years

RDE will be based on cumulative safety, preliminary antitumor activity and pharmacokinetics findings

Part 2: Recommended Dose for future development
From the first day through 30-37 days after the last study treatment, up to approximately 2 years

Safety, and preliminary anti-tumor activity

Secondary Endpoints
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)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1EXPERIMENTALMonotherapy Dose Escalation
Part 2EXPERIMENTALMonotherapy Dose Expansion
Interventions
NameTypeDescription
PF-07994525DRUGOral administration
MidazolamDRUGOral administration
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Participants aged 18 years or older (or the minimum age of consent in accordance with local regulations) at the time of informed consent. * Prior diagnosis of MM as defined according to IMWG criteria (Rajkumar et al. 2014) Measurable disease based on IMWG criteria as defined ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT07426757Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 2, 2026NCT07426757Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 2, 2026NCT07426757Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 26, 2026NCT07426757primaryCompletionDate: changed
LOWMay 24, 2026NCT07426757studyFirstPostDate: changed