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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-28

Study Completion Date

2026-03-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Microsatellite Stable Metastatic Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Evorpacept (ALX148)

Intervention Type DRUG

IV QW

Cetuximab

Intervention Type DRUG

IV QW

Pembrolizumab

Intervention Type DRUG

IV Q3W

Interventions

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Evorpacept (ALX148)

IV QW

Intervention Type DRUG

Cetuximab

IV QW

Intervention Type DRUG

Pembrolizumab

IV Q3W

Intervention Type DRUG

Other Intervention Names

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evorpacept Erbitux Keytruda

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No