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

NCT05167409 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 22-0110.ccNCI-2022-02019AGICC-ALX148 21CRC01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Microsatellite Stable Metastatic Colorectal Cancer

Keywords

evorpacept (ALX148); Cetuximab; Pembrolizumab; CRC; colorectal cancer; microsatellite stable; MSS; CD47; SIRPa

Outcome Measures

Primary Outcomes (2)

• Recommended dose (RD) of evorpacept (ALX148) in combination with cetuximab and pembrolizumab 1.(mg/kg)

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

  4 months

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

  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

  6 months

Secondary Outcomes (6)

• 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

• Overall survival (OS)

  48 months

• First cycle dose-limiting toxicities in the safety run-in stage

  4 months

Study Arms (1)

Evorpacept (ALX148) + cetuximab + pembrolizumab

EXPERIMENTAL

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

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

Interventions

Evorpacept (ALX148) DRUG

IV QW

Also known as: evorpacept

Evorpacept (ALX148) + cetuximab + pembrolizumab

Cetuximab DRUG

IV QW

Also known as: Erbitux

Evorpacept (ALX148) + cetuximab + pembrolizumab

Pembrolizumab DRUG

IV Q3W

Also known as: Keytruda

Evorpacept (ALX148) + cetuximab + pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead
• ALX Oncology Inc.: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Eli Lilly and Company: collaborator
• Criterium, Inc.: collaborator
• Academic GI Cancer Consortium (AGICC): collaborator

Study Sites (4)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Rutgers Cancer insititute

New Brunswick, New Jersey, 08903, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

ALX148; Cetuximab; pembrolizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Robert Lentz, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: December 22, 2021
• Study Start: July 28, 2022
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

US (4)