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Trial record 1 of 11 for:    alx148
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A Study of 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 : July 29, 2022
Sponsor:
Collaborators:
ALX Oncology Inc.
Merck Sharp & Dohme LLC
Eli Lilly and Company
Information provided by (Responsible Party):
Criterium, Inc.

Brief Summary:
This Phase 2 clinical study will evaluate 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: 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 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.

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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 ALX148 in Combination With Cetuximab and Pembrolizumab in Patients With Refractory Microsatellite Stable Metastatic Colorectal Cancer
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : March 1, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALX148 + cetuximab + pembrolizumab
ALX148 + cetuximab + pembrolizumab. ALX148 15 mg/kg IV weekly, cetuximab 400 mg/m2 once then 250 mg/m2 weekly, and pembrolizumab 200 mg every 3 weeks
Drug: ALX148
IV QW
Other Name: evorpacept

Drug: Cetuximab
IV QW
Other Name: Erbitux

Drug: Pembrolizumab
IV Q3W
Other Name: Keytruda




Primary Outcome Measures :
  1. Recommended dose (RD) of ALX148 in combination with cetuximab and pembrolizumab 1.(mg/kg) [ Time Frame: 4 months ]
    To determine the recommended dose (RD) of 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 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 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 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 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 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 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 ALX148, cetuximab, and pembrolizumab, defined and graded according to the NCI CTCAE v5.0



Information from the National Library of Medicine

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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)

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, PharmD 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 Not yet 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 Not yet 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   
Sponsors and Collaborators
Criterium, Inc.
ALX Oncology Inc.
Merck Sharp & Dohme LLC
Eli Lilly and Company
Investigators
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Principal Investigator: Wells Messersmith, MD University of Colorado, Denver
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Responsible Party: Criterium, Inc.
ClinicalTrials.gov Identifier: NCT05167409    
Other Study ID Numbers: AGICC-ALX148 21CRC01
First Posted: December 22, 2021    Key Record Dates
Last Update Posted: July 29, 2022
Last Verified: July 2022

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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 Criterium, Inc.:
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