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PF-08046876

Phase 1

Advanced/Metastatic Solid Tumors | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Apr 7, 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 Enrollment310
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07090499A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid TumorsPHASE1 RECRUITING 310 — — Aug 20, 2025Jul 8, 2029Apr 7, 202628 United States, Canada +3
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Study Endpoints
Primary Endpoints
Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation
Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)

AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy dose modifications.

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

Occurrence of DLTs as defined by the protocol

Part 1: Recommended Monotherapy Dose for Expansion
Baseline to 30 days post last study drug administration

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

Part 2: Recommended Phase 2 Dose
Baseline to 30 days post last study drug administration

RP2D will be determined based on the cumulative safety, preliminary anti tumor activity and Pharmacokinetics findings.

Secondary Endpoints
Objective Response Rate (ORR)
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)
From the date of the first objective response to the date of disease progression or death (approximately 2 years)
Progression Free Survival (PFS)
From Baseline to date of first disease progression or death (approximately 2 Years)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1 Dose EscalationEXPERIMENTALDifferent groups of participants will receive different doses and/or schedules of the study drug
Part 2 Dose OptimizationEXPERIMENTALParticipants will be randomized to 2 dosing regimens deemed to be safe in Part 1
Part 2 Dose ExpansionEXPERIMENTALParticipants in tumor-specific groups will receive 1 dosing regimen deemed to be safe in Part 1
Interventions
NameTypeDescription
PF-08046876DRUGIntravenous administration
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * 18 years of age or older * Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas * Measurable disease * ECOG Performance status 0-1 * Part 1: progression or relapse following standard treatments * Part 2: maximum of 2 prior lines of systemic therapy in th...

Countries:United StatesCanadaPuerto RicoSpainUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07090499primaryCompletionDate: changed
LOWMay 24, 2026NCT07090499studyFirstPostDate: changed