Xcovery has started a Phase II clinical trial of ensartinib (X-396) to treat patients with advanced malignant melanoma possessing alterations in anaplastic lymphoma kinase (ALK), including ALK(ATI).

The open-label, single-arm study is enrolling patients with melanoma who currently or previously received a PD-1 based therapy, and a BRAF-based therapy if BRAF V600 is mutated.

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The trial is being conducted by Memorial Sloan Kettering Cancer Center (MSK) in the US and is led by MSK department of medicine/melanoma and immunotherapeutics services representative Dr Alexander Shoushtari. It includes the screening and treatment phases.

During the screening phase, archival tumour tissues from current and future patient candidates for this trial will be tested for ALK(ATI) alteration using a Nanostring-based RNA assay at MSK.

Patients whose tumours express ALK(ATI) will be eligible to take part in the trial’s treatment phase.

The trial’s primary endpoint is to determine the clinical benefit rate (CBR) of ensartinib in this patient population.

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“This trial could represent a new treatment option for patients who currently have few options.”

CBR will be defined by response evaluation in solid tumours (RECIST) 1.1 or stable disease until the 24-week assessment.

Shoushtari said: “While there has been significant clinical advancements in the treatment of advanced malignant melanoma, 30% to 40% of patients do not respond to immune-based therapy or will develop therapeutic resistance.

“This is a promising trial that uses an RNA-based assay to identify an epigenentically regulated tumour growth mechanism and if deemed favourable for further study, this trial could represent a new treatment option for patients who currently have few options.”

The ensartinib (X-396) is a potent ALK inhibitor currently being studied in a global Phase lll trial in ALK positive non-small cell lung cancer patients.

Alongside ALK, ensartinib potently inhibits TRKA fusions, TRKC, ROS1, EphA2, and c-MET.