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PF-08046050

Phase 1

Colorectal Neoplasms | 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment914
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06131840A Study of SGN-CEACAM5C in Adults With Advanced Solid TumorsPHASE1 RECRUITING 914 — — Nov 20, 2023Sep 12, 2030Apr 20, 202644 United States, Canada +6
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Study Endpoints
Primary Endpoints
Number of participants with adverse events (AEs)
Through 30-37 days after the last study treatment, up to approximately 2 years

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention

Number of participants with laboratory abnormalities
Through 30-37 days after the last study treatment, up to approximately 2 years
Number of dose modifications due to AEs
Through end of treatment up to approximately 2 years
Number of participants with dose-limiting toxicities (DLTs)
Up to 28 days
Number of participants with DLTs by dose level
Up to 28 days
Secondary Endpoints
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)
Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Maximum concentration (Cmax)
Through 30-37 days after the last study treatment, up to approximately 2 years
PK parameter - Time to maximum concentration (Tmax)
Through 30-37 days after the last study treatment, up to approximately 2 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PF-08046050EXPERIMENTALPF-08046050 monotherapy
PF-08046050 +bevacizumabEXPERIMENTALPF-08046050 combination with bevacizumab
PF-08046050 + bevacizumab + 5FU/LVEXPERIMENTALPF-08046050 combination with bevacizumab + 5FU/LV
PF-08046050 + 5FU/LV + oxaliplatin + bevacizumabEXPERIMENTALPF-08046050 combination with 5FU/LV + oxaliplatin + bevacizumab
PF-08046050 + 5FU/LV + oxaliplatinEXPERIMENTALPF-08046050 combination with 5FU/LV + oxaliplatin
PF-08046050 + 5FU/LVEXPERIMENTALPF-08046050 combination with 5FU/LV
Interventions
NameTypeDescription
PF-08046050DRUGGiven into the vein (IV; intravenous)
bevacizumabDRUGGiven into the vein (IV; intravenous)
5-Fluorouracil (5-FU)DRUGGiven into the vein (IV; intravenous)
OxaliplatinDRUGGiven into the vein (IV; intravenous)
Leucovorin (LV)DRUGGiven into the vein (IV; intravenous)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites44

Inclusion Criteria: 1. Tumor type: * Participants in Part A (dose escalation) and Part B (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy. Must have relapsed, refractory, or progressive disease, and should have no appropr...

Countries:United StatesCanadaChinaFranceNetherlandsSpainSwedenUnited Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06131840primaryCompletionDate: changed
LOWMay 24, 2026NCT06131840studyFirstPostDate: changed