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PF-07994525

Phase 1

Advanced Malignancies | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Aug 17, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

Clinical trial landscape

PF-07994525 · 1 trial · 2 indications

Phase 1 1
NCT07426757An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced CancersAdvanced Malignancies
RECRUITING120 Analytics
PHASE1RECRUITING
An Open-Label Study to Evaluate PF-07994525 in Participants With Advanced Cancers
Advanced MalignanciesUnlock trial analytics

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 Expansion
Part 2EXPERIMENTALMonotherapy Dose Escalation

Interventions

NameTypeDescription
PF-07994525DRUGOral administration
MidazolamDRUGOral administration
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites19

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 StatesCanada
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Recent Changes (Last 90 Days)

LOWAug 17, 2026NCT07426757lastUpdatePostDate: changed
LOWAug 17, 2026NCT07426757lastUpdatePostDate: changed
LOWJul 22, 2026NCT07426757startDate: changed
LOWJul 22, 2026NCT07426757startDate: changed

Frequently asked questions about PF-07994525

What is PF-07994525 used for?

PF-07994525 is an investigational small molecule being developed for the treatment of advanced malignancies, including advanced cancer. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes PF-07994525?

PF-07994525 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE.

What phase is PF-07994525 in?

PF-07994525 is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The drug is being studied in an open-label, controlled trial for advanced malignancies.

What clinical trials is PF-07994525 in?

PF-07994525 is being evaluated in a Phase 1 clinical trial with the identifier NCT07426757. This open-label study is recruiting participants with advanced malignancies or advanced cancer in the United States and Canada, with a target enrollment of 120 participants aged 18 years and older.

Is PF-07994525 the same as any other drug?

No alternative names for PF-07994525 have been disclosed. The drug is identified solely by its development code PF-07994525 in clinical trial registries and by the sponsor, Pfizer, Inc.