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Evorpacept

Phase 2

Microsatellite Stable Metastatic Colorectal Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Jan 13, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05167409A Study of Evorpacept (ALX148) With Cetuximab and Pembrolizumab for Refractory Microsatellite Stable Metastatic Colorectal CancerPHASE2 ACTIVE NOT_RECRUITING 48Jul 28, 2022Mar 1, 2026Jan 13, 20254 United States
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Study Endpoints
Primary Endpoints
Recommended dose (RD) of evorpacept (ALX148) in combination with cetuximab and pembrolizumab 1.(mg/kg)
4 months

To determine the recommended dose (RD) of evorpacept (ALX148) in combination with cetuximab and pembrolizumab

Objective response rate (ORR, per RECIST v1.1) (%)
6 months

To determine the objective response rate (ORR), defined as partial response or complete response, with evorpacept (ALX148), cetuximab, and pembrolizumab using RECIST v1.1 in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) who have progressed on at least two lines of standard therapy

Secondary Endpoints
Disease control rate per RECIST v1.1. (%)
24 months
Duration of response per RECIST v1.1. (months)
24 months
Progression-free survival (PFS, per RECIST v1.1) (months)
48 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Evorpacept (ALX148) + cetuximab + pembrolizumabEXPERIMENTALEvorpacept (ALX148) + cetuximab + pembrolizumab. Evorpacept (ALX148) 15 mg/kg IV weekly, cetuximab 400 mg/m2 once then 250 mg/m2 weekly, and pembrolizumab 200 mg every 3 weeks
Interventions
NameTypeDescription
Evorpacept (ALX148)DRUGIV QW
CetuximabDRUGIV QW
PembrolizumabDRUGIV Q3W
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: To be eligible to participate in this study, an individual must meet all of the following criteria: * Have a diagnosis of metastatic colorectal cancer previously treated with at least two lines of therapy for unresectable/metastatic disease * Have microsatellite stable disease ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05167409primaryCompletionDate: changed
LOWMay 24, 2026NCT05167409studyFirstPostDate: changed