Biotech company InxMed has dosed the first patient in its Phase Ib trial evaluating IN10018 as a monotherapy and combination therapy in patients with metastatic uveal melanoma and NRAS mutant metastatic melanoma in the US.
The open-label trial will evaluate the safety, tolerability, PK and anti-tumour activities of IN10018 as a monotherapy and in combination with Roche’s MEK inhibitor Cobimetinib in the subjects.
It will include six study sites in the US and three study sites in Australia.
Formerly known as BI853520, IN10018 is a potent and selective ATP-competitive focal adhesion kinase (FAK) small molecule inhibitor.
The drug is currently under clinical development stage in the US, Australia, and China.
InxMed chairman and CEO Dr Zaiqi Wang said: “We feel very excited about the dosing of (the) first patient of IN10018 in the US and fortunate to work with leading experts from both US and Australia.
“We hope that IN10018, alone or in combination with MEK inhibitor, is able to offer a new approach that improves therapeutic outcomes for the patients with deadly uveal melanoma or advanced, NRAS-mutant melanoma.”
Early clinical data of IN10018 has demonstrated a favourable safety profile and promising efficacy signals against a number of tumour types.
In a number of preclinical studies, the drug showed an anti-tumour effect against both uveal melanoma and NRAS mutant metastatic melanoma.
Such studies have also observed synergistic efficacy between IN10018 and MEK inhibitor.
Uveal melanoma is considered the most common type of intraocular cancer. The condition is said to exhibit a very dismal prognosis once it metastasises. Metastatic uveal melanoma currently has no approved medicines.