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

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ClinicalTrials.gov Identifier: NCT05167409
Recruitment Status : Recruiting
First Posted : December 22, 2021
Last Update Posted : March 2, 2023
Sponsor:
Collaborators:
ALX Oncology Inc.
Merck Sharp & Dohme LLC
Eli Lilly and Company
Criterium, Inc.
Information provided by (Responsible Party):
University of Colorado, Denver

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

Condition or disease Intervention/treatment Phase
Microsatellite Stable Metastatic Colorectal Cancer Drug: Evorpacept (ALX148) Drug: Cetuximab Drug: Pembrolizumab Phase 2

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study (With Safety run-in) of Evorpacept (ALX148) in Combination With Cetuximab and Pembrolizumab in Patients With Refractory Microsatellite Stable Metastatic Colorectal Cancer
Actual Study Start Date : July 14, 2022
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : March 1, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Evorpacept (ALX148) + cetuximab + pembrolizumab
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)
IV QW
Other Name: evorpacept

Drug: Cetuximab
IV QW
Other Name: Erbitux

Drug: Pembrolizumab
IV Q3W
Other Name: Keytruda


Outcome Measures
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Primary Outcome Measures :
  1. Recommended dose (RD) of evorpacept (ALX148) in combination with cetuximab and pembrolizumab 1.(mg/kg) [ Time Frame: 4 months ]
    To determine the recommended dose (RD) of evorpacept (ALX148) in combination with cetuximab and pembrolizumab

  2. Objective response rate (ORR, per RECIST v1.1) (%) [ Time Frame: 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 Outcome Measures :
  1. Disease control rate per RECIST v1.1. (%) [ Time Frame: 24 months ]
    To determine the disease-control rate (DCR), defined as stable disease, partial response, or complete response with evorpacept (ALX148), cetuximab, and pembrolizumab using RECIST v1.1

  2. Duration of response per RECIST v1.1. (months) [ Time Frame: 24 months ]
    To determine the duration of response (DOR) with evorpacept (ALX148), cetuximab, and pembrolizumab, defined as the time from response (partial or complete) to progression

  3. Progression-free survival (PFS, per RECIST v1.1) (months) [ Time Frame: 48 months ]
    To determine the progression-free survival (PFS) with evorpacept (ALX148), cetuximab, and pembrolizumab, defined as the time from enrollment to the first observation of progression using RECIST v1.1 or death from any cause

  4. Overall survival (OS) [ Time Frame: 48 months ]
    To determine the overall survival (OS) with evorpacept (ALX148), cetuximab, and pembrolizumab, defined as the time from enrollment to death from any cause

  5. First cycle dose-limiting toxicities in the safety run-in stage [ Time Frame: 4 months ]
    To determine the first cycle dose-limiting toxicities (DLT) of evorpacept (ALX148), cetuximab, and pembrolizumab in stage 1

  6. Safety and tolerability according to the NCI CTCAE v5.0 [ Time Frame: 48 months ]
    To evaluate the safety and tolerability of evorpacept (ALX148), cetuximab, and pembrolizumab, defined and graded according to the NCI CTCAE v5.0


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05167409


Contacts
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Contact: Ash Philpott, PhD 404 884 4701 aphilpott@criteriuminc.com
Contact: Ruth Stone 15185830095 restone@criteriuminc.com

Locations
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United States, Arizona
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Daniel Pennington    520-694-9065    danielpennington@arizona.edu   
Principal Investigator: Aaron Scott         
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Alicia Mcgregor    303-724-8651    ALICIA.MCGREGOR@CUANSCHUTZ.EDU   
Principal Investigator: Wells Messersmith         
United States, New Jersey
Rutgers Cancer insititute Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Howard Hochster    732-235-5912    hh458@cinj.rutgers.edu   
United States, New York
Perlmutter Cancer Center Not yet recruiting
New York, New York, United States, 10016
Contact: Paul Oberstein, MD    929-455-2433    Paul.Oberstein@nyulangone.org   
Contact: Keith Kallas    929-455-2433    Keith.Kallas@nyulangone.org   
United States, Virginia
Inova Schar Cancer Institute Not yet recruiting
Fairfax, Virginia, United States, 22031
Contact: Raymond Wadlow    571-472-4724    Raymond.Wadlow@inova.org   
Contact: Cynthia Ballentine    571.472.0237|    Cynthia.Ballentine@inova.org   
Sponsors and Collaborators
University of Colorado, Denver
ALX Oncology Inc.
Merck Sharp & Dohme LLC
Eli Lilly and Company
Criterium, Inc.
Investigators
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Principal Investigator: Wells Messersmith, MD University of Colorado, Denver
More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT05167409    
Other Study ID Numbers: 22-0110.cc
NCI-2022-02019 ( Other Identifier: CTRP )
First Posted: December 22, 2021    Key Record Dates
Last Update Posted: March 2, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
evorpacept (ALX148)
Cetuximab
Pembrolizumab
CRC
colorectal cancer
 microsatellite stable
MSS
CD47
SIRPa
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pembrolizumab
Cetuximab
Antineoplastic Agents, Immunological
Antineoplastic Agents