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Ulixertinib

Phase 1

Tumor, Solid | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Sep 11, 2025

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 Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03454035Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid TumorsPHASE1 RECRUITING 45Jan 30, 2018Nov 24, 2026Sep 11, 20251 United States
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Study Endpoints
Primary Endpoints
Maximum Tolerated Dose (MTD)
Five weeks

MTD of ulixertinib in combination with palbociclib in patients with advanced solid tumors of ulixertinib in combination with palbociclib in patients with advanced solid tumors

Overall Survival
6 months after treatment

For Expansion Cohort: To estimate overall survival (OS) after treatment with the recommended phase 2 dose of ulixertinib in combination with palbociclib in an expansion cohort of patients with metastatic pancreatic cancer

Secondary Endpoints
Safety (number of patients with adverse events)
5 weeks
Objective Response Rate
8 weeks
Progression-free survival
Up to two years after treatment
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Open-label, single arm Phase IEXPERIMENTALUlixertinib added to palbociclib
Interventions
NameTypeDescription
UlixertinibDRUGUlixertinib 300mg, orally, twice a day concomitantly with palbociclib
PalbociclibDRUGDrug: Palbociclib 125mg, orally, once a day concomitantly with ulixertinib
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately. 2. Age ≥ 18 years at the time of consent (no upper age limit) 3. Eastern Cooperative Oncology...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT03454035primaryCompletionDate: changed
LOWMay 24, 2026NCT03454035studyFirstPostDate: changed