Agnostic basket trial for uveal melanoma gets FDA nod

9th May 2019 (Last Updated May 9th, 2019 13:10)

IDEAYA Biosciences has received the US Food and Drug Administration (FDA) clearance to perform a Phase I/II tissue-type agnostic basket clinical trial for evaluating IDE196 as a potential therapy for metastatic uveal melanoma (UM).

In addition to uveal melanoma, the trial will also involve patients with other solid tumours harbouring GNAQ or GNA11 (GNAQ/11) mutations and PKC fusions, such as cutaneous melanoma and colorectal cancer.

According to American Society of Clinical Oncology (ASCO), basket trial is a type of precision medicine study to simultaneously assess the effect of a single drug on a single mutation in multiple tumour types.

This type of trials are said to have the potential to significantly increase the number of eligible subjects to receive select drugs, compared to other study designs.

The new Phase I/II tissue-type agnostic basket trial will be based on a genetic biomarker rationale for the treatment of patients who currently lack GNAQ or GNA11-specific targeted therapies.

IDEAYA is planning to start the study in the second or third quarter of this year.

IDE196 is a potent small molecule inhibitor of protein kinase C (PKC). In an ongoing Phase I trial, the compound is said to have demonstrated early clinical activity and tolerability in metastatic UM.

The company noted that IDE196 is active across the classical as well as new PKC isoforms, and is highly selective compared to other kinases.

IDE196 clinical investigator and University of Sydney clinical associate professor Dr Matteo Carlino said: “Patients with metastatic UM generally have a poor prognosis, with historic clinical response rates generally ranging from 0% to 10% and median overall survival of ten months.

“In light of this significant patient need and the promising activity seen in the initial IDE196 clinical study, we are excited for continued development of IDE196 to further evaluate its clinical potential.”

Initially, the Phase I/II study will focus on patients with tumours that possibly have pathogenic ‘hotspot’ mutations known to induce the PKC signalling pathway.