ALX Oncology has begun the Phase II clinical trial of evorpacept plus Erbitux (cetuximab) and Keytruda (pembrolizumab) in refractory microsatellite stable metastatic colorectal cancer (mCRC) patients. 

The combination treatment is intended for mCRC patients who have advanced following a minimum of two lines of systemic therapy.

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The investigator-sponsored, open-label, single-arm, multicentre trial is being managed by contract research organisation Criterium.

A lead product candidate of the company, evorpacept is a next generation CD47 blocker.

It merges a CD47 binding domain of greater affinity with an inactivated Fc domain. 

The therapy showed favourable clinical responses in various haematologic and solid malignancies, along with various anti-cancer agents. 

ALX has the global commercial rights to evorpacept.

Keytruda is an anti-PD-1 therapy of Merck (MSD outside North America) while Eli Lilly and Company will provide Erbitux for the trial.

Trial co-lead University of Colorado Cancer Center Medical Oncology professor and head Wells Messersmith said: “In conjunction with AGICC, we are excited to initiate this study that builds upon the promising clinical activity and tolerability observed in patients with advanced solid tumours observed in ASPEN-01, ALX Oncology’s Phase Ib study. 

“From a mechanistic perspective, the combination of a CD47 blocker with cetuximab and pembrolizumab acts through different but complementary mechanisms, and we aim to see evorpacept in this triplet combination positively impact efficacy without increasing toxicity.”

ALX also plans to advance evorpacept’s clinical development to treat various hematologic malignancies and solid tumour indications.

In October last year, the company and Zymeworks dosed the first subject in the Phase Ib/II trial of Zanidatamab plus evorpacept in patients with advanced human epidermal growth factor receptor 2 (HER2)-expressing breast cancer and various solid tumours.