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PF-08046049

Phase 1

Cutaneous Melanoma | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Apr 20, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05571839A Study of PF-08046049/SGN-BB228 in Advanced Melanoma and Other Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 41 — — Jan 3, 2023Jun 6, 2026Apr 20, 202636 United States, Canada +4
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Study Endpoints
Primary Endpoints
Number of participants with adverse events (AEs)
Through 30 days after the last study treatment; approximately 7 months

Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.

Number of participants with laboratory abnormalities
Through 30 days after the last study treatment; approximately 7 months
Number of participants with dose limiting toxicities
Up to 28 days
Secondary Endpoints
Number of participants with antidrug antibodies
Through 30 days after the last study treatment; approximately 7 months
Pharmacokinetic (PK) parameter - Area under the curve (AUC)
Through 30 days after the last study treatment; approximately 7 months
PK parameter - Maximum Concentration (Cmax)
Through 30 days after the last study treatment; approximately 7 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-08046049EXPERIMENTALPF-08046049 monotherapy
Interventions
NameTypeDescription
PF-08046049DRUGGiven into the vein (IV; intravenous)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites36

Inclusion Criteria: * All Parts: Participants must have disease that is relapsed, refractory, or intolerant to standard of care. Participants must have histologically or cytologically confirmed metastatic malignancy. * Participants must have one of the following tumor types: * Parts A and B: Par...

Countries:United StatesCanadaFranceGermanySwitzerlandUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05571839primaryCompletionDate: changed
LOWMay 24, 2026NCT05571839studyFirstPostDate: changed