BioLineRx has commenced a Phase l/lla clinical trial to investigate the safety and tolerability of AGI-134 for the treatment of unresectable metastatic solid tumours.

Planned to be held in the UK and Israel, the multicentre, open-label trial is expected to be expanded to sites in the US and other European countries next year.

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The trial will include two parts, one of which comprises an accelerated dose-escalation portion to evaluate the safety and tolerability of intratumorally injected AGI-134 as a monotherapy.

The first part is also expected to identify the maximum tolerated dose and the recommended dose for part two of the trial.

The second part will include a dose-expansion phase at the recommended dose.

It will feature three cohorts of patients to evaluate the safety, tolerability and anti-tumour activity of AGI-134 as a monotherapy in a basket cohort of multiple solid tumour types.

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“More treatment options are urgently needed for cancer patients and we are optimistic that AGI-134’s encouraging pre-clinical results are going to translate to an efficacious and safe treatment for humans.”

Two additional cohorts will also be included to evaluate AGI-134 in combination with an immune checkpoint inhibitor to treat metastatic colorectal cancer and head and neck squamous cell carcinoma.

The trial’s additional objectives are to perform various biomarker studies and to demonstrate the mechanism of AGI-134, as well as efficacy as measured by clinical and pharmacodynamic parameters.

The study’s principal investigator Mark Middleton said: “AGI-134 represents a new mechanistic class of cancer immunotherapies, with a unique and highly differentiated mode of action, harnessing pre-existing immune machinery to trigger a systemic anti-tumour response and create a pro-inflammatory tumour microenvironment.

“More treatment options are urgently needed for cancer patients and we are optimistic that AGI-134’s encouraging pre-clinical results are going to translate to an efficacious and safe treatment for humans.”

Results of the Phase l/lla trial are expected to be available by the end of 2020.