IDEAYA Biosciences has commenced an Investigator Sponsored Trial (IST) of darovasertib (IDE196) for treating patients with primary, non-metastatic uveal melanoma (UM).
Named NADOM, the trial will be carried out in partnership with St. Vincent’s Hospital, Sydney, Australia.
It will assess darovasertib as a single agent in neo-adjuvant and adjuvant settings in adult ocular melanoma patients to validate the tolerability and feasibility.
Apart from St. Vincent’s Hospital, Alfred Health and the Royal Victorian Eye and Ear Hospital in Melbourne will be the other sites of the trial.
A selective small molecule protein kinase C (PKC) inhibitor, darovasertib received Orphan Drug Designation from the US Food and Drug Administration for UM in April this year.
IDEAYA Biosciences Clinical Oncology and Medical Affairs vice-president, head Dr Matthew Maurer said: “There are currently limited treatment options for patients with uveal melanoma in the pre-metastatic setting.
“We are pleased to be collaborating with St. Vincent’s Hospital in Sydney and with Alfred Health and Royal Victorian Eye and Ear Hospital in Melbourne to explore the potential for darovasertib monotherapy to be impactful for patients with primary uveal melanoma.”
Apart from the NADOM trial, the company is analysing a synthetic lethal combination of darovasertib plus a small molecule cMET inhibitor, crizotinib, for metastatic uveal melanoma (MUM) in a Phase II trial.
This trial is progressing under a partnership and drug supply agreement with Pfizer.
IDEAYA anticipates reporting clinical proof-of-concept findings for the UM trial and interim data from the MUM trial in September this year.
A rare kind of melanoma, UM arises from the iris melanocytes.
In April last year, the company announced the first-patient-in (FPI) Phase I clinical trial of IDE397 to treat methylthioadenosine phosphorylase deletion solid tumours.