NEW YORK – Biotech company InxMed said on Monday that it dosed the first patient in its Phase IB clinical trial involving its investigational FAK inhibitor IN10018 as a monotherapy and in combination with the MEK inhibitor cobimetinib (Genentech's Cotellic) for patients with NRAS-mutated metastatic melanoma or uveal melanoma.
The patient was dosed at the University of Texas MD Anderson Cancer Center. The open-label, Phase IB trial will be conducted at study sites in the US and Australia. Its aim is to evaluate the safety, tolerability, and activity of the therapies.
The trial will enroll up to 52 patients. One of the exploratory aims of the trial is to look at other potential predictive biomarkers of response, such as the level of Phospho-FAK.
In pre-clinical studies, IN10018 displayed anti-tumor effects against NRAS-mutated metastatic melanoma and uveal melanoma. Its efficacy was boosted in some cases when combined with a MEK inhibitor.
NRAS mutations occur in about 15 percent to 20 percent of melanoma patients and is the second most common oncogenic driver in melanoma. No targeted treatment has been approved for this molecularly defined indication.
Cobimetinib has previously been studied in combination with BRAF V600E inhibitor vemurafenib (Roche and Plexxikon's Zelboraf) in advanced melanoma.
Revolution Medicines is also exploring cobimetinib in combination with its investigational SHP2 inhibitor RMC-4630 in RTK, KRAS, BRAF Class 3, or NF1 LOF-mutated solid tumors.