Nuvectis Pharma will test its solid tumour treatment candidate for the first time in human trials after the biopharma announced it had initiated a Phase Ia trial.
The dose escalation clinical trial (NCT05873686) will assess the safety, tolerability and pharmokinetic properties of its candidate NXP900 – an SRC/YES1 kinase family (SFK) inhibitor. SFKs are activated in cancer and are an integral component in tumour growth. Various oncogenic processes such as proliferation, survival, cell adhesion, invasion, and angiogenesis can be halted via inhibition of SFKs.
In a statement, Nuvectis said that NXP900 had demonstrated single-agent anti-cancer activity against solid tumours in preclinical studies.
The US Food and Drug Administration (FDA) granted an investigational new drug application (IND) for NXP900 in May 2023.
According to the ClinicalTrials.gov entry, 40 adults with solid tumours are estimated to enrol in the study. Escalating doses of the candidate will be orally administered from a starting dose level of 20mg once per day. Nuvectis will assess treatment-related adverse events and the number of patients experiencing dose-limiting toxicities 28 days post-treatment.
Ron Bentsur, co-Founder, chairman and CEO of Nuvectis said in a statement: “We believe that NXP900’s unique mechanism of action, which completely shuts down signalling via SFK, in conjunction with its high target specificity, differentiates it from other multi-kinase inhibitors that also inhibit SFK and provide it with the potential to become the first SFK inhibitor for the treatment of solid tumours.”
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Last month, the company announced the FDA had granted orphan drug designation for another of its pipeline candidates – NXP800 – for the treatment of cholangiocarcinoma.