A Study of Evorpacept (ALX148) With Cetuximab and Pembrolizumab for Refractory Microsatellite Stable Metastatic Colorectal Cancer

University of Colorado Denver (CU Denver)

Status and phase: Active, not recruiting; Phase 2

Conditions: Microsatellite Stable Metastatic Colorectal Cancer

Treatments: Drug: Pembrolizumab; Drug: Evorpacept (ALX148); Drug: Cetuximab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05167409

22-0110.cc

NCI-2022-02019 (Other Identifier)

AGICC-ALX148 21CRC01

Details and patient eligibility

About

This Phase 2 clinical study will evaluate evorpacept (ALX148) in combination with cetuximab and pembrolizumab for refractory microsatellite stable metastatic colorectal cancer

Full description

This is an open-label, multi-center, single-arm phase II clinical trial (with safety run-in) evaluating the combination of evorpacept (ALX148), cetuximab, and pembrolizumab in patients with metastatic microsatellite stable colorectal cancer who have progressed on at least 2 lines of systemic therapy. A subset of patients will undergo study-related biopsies. There will be a safety run-in stage followed by a dose expansion stage. Patients in both stages will continue to receive study therapy until disease progression according to RECIST v1.1.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Adequate hematologic and end organ function

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

• Patients with known MSI-high status or known mismatch repair deficiency (dMMR)
• Patients in whom both mismatch repair and microsatellite stability status are unknown
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to any of the study medications or their classes
• Left-sided (at or distal to the splenic flexure) RAS/BRAF wild-type metastatic colorectal cancer who are EGFR inhibitor naïve.
• Prior therapy with an anti-PD-1, anti-PD-L1, anti PD L2, anti-CD47, or anti-SIRPα agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Evorpacept (ALX148) + cetuximab + pembrolizumab

Experimental group

Description:

Evorpacept (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

Treatment:

Drug: Cetuximab

Drug: Evorpacept (ALX148)

Drug: Pembrolizumab