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Evorpacept

Phase 2

Microsatellite Stable Metastatic Colorectal Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Jan 13, 2025

Target and mechanism

Molecular targetCD47
Target classInhibitor
ModalitySmall molecule

Also known as Evorpacept (ALX148)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

Evorpacept · 1 trial · 1 indication

Phase 2 1
NCT05167409A Study of Evorpacept (ALX148) With Cetuximab and Pembrolizumab for Refractory Microsatellite Stable Metastatic Colorectal CancerMicrosatellite Stable Metastatic Colorectal Cancer
ACTIVE NOT_RECRUITING48 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study of Evorpacept (ALX148) With Cetuximab and Pembrolizumab for Refractory Microsatellite Stable Metastatic Colorectal Cancer
Microsatellite Stable Metastatic Colorectal CancerUnlock trial analytics

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 to 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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Frequently asked questions about Evorpacept

What is Evorpacept used for?

Evorpacept is being studied for the treatment of Microsatellite Stable Metastatic Colorectal Cancer. It is an investigational small molecule in Phase 2 clinical development. The drug is being evaluated in combination with cetuximab and pembrolizumab for patients with refractory microsatellite stable metastatic colorectal cancer.

What does Evorpacept target?

Evorpacept targets CD47, a protein that cancer cells use to evade the immune system. By blocking CD47, Evorpacept may enhance the ability of the immune system to attack cancer cells. This mechanism is being studied in the context of microsatellite stable metastatic colorectal cancer.

Who makes Evorpacept?

Evorpacept is being developed by Merck & Company, Inc., which is listed on the stock exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with microsatellite stable metastatic colorectal cancer.

What phase is Evorpacept in?

Evorpacept is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 2 trial is active but not recruiting participants, and it is studying the drug in combination with other therapies for refractory microsatellite stable metastatic colorectal cancer.

What clinical trials is Evorpacept in?

Evorpacept is being studied in a Phase 2 clinical trial with the identifier NCT05167409. This trial is titled 'A Study of Evorpacept (ALX148) With Cetuximab and Pembrolizumab for Refractory Microsatellite Stable Metastatic Colorectal Cancer.' The trial is active but not recruiting, with an enrollment of 48 participants in the United States.

Is Evorpacept the same as ALX148?

Yes, Evorpacept is also known as ALX148. The drug is referred to by both names in clinical research. The ongoing Phase 2 trial NCT05167409 uses the name Evorpacept (ALX148) to describe the investigational therapy being studied for microsatellite stable metastatic colorectal cancer.