The study of NXP800 for ovarian carcinoma will be conducted in 25-30 sites in US, UK and Europe. Credit: Nephron / commons.wikimedia.org

Nuvectis Pharma has started the Phase Ib trial of NXP800 for the treatment of patients with platinum-resistant, ARID1a-mutated ovarian carcinoma.

A tumour type, ARID1a-mutated ovarian cancer consists of ovarian clear-cell carcinoma (OCCC) and ovarian endometrioid carcinoma (OEC).

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The Phase Ib trial has been designed to examine NXP800’s tolerability, safety and preliminary efficacy in the target patients and will enrol two cohorts of up to around 25 patients each.

It will assess 50mg and 75mg doses of the drug, administered once-a-day, selected based on results obtained from the Phase Ia dose escalation trial in patients with different advanced solid tumour types.

The first-in-human Phase Ia trial evaluated two different dosages including once per day (total daily doses of 50mg to 150mg) and twice per day (total daily doses of 100mg and 150mg).

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Currently, 18 patients have received at least one dose of the drug in the duration of 10 months in this trial and the treatment is ongoing.

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The Phase Ib trial will be carried out in 25 to 30 sites in the US, UK and Europe in partnership with the European Network of Gynaecological Oncological Trial Groups and the GOG Foundation.

Nuvectis CEO and chairman Ron Bentsur said: “We are excited to announce the initiation of the Phase Ib study in which NXP800 will be tested, for the first time, in patients with a target disease.

“The robust preclinical anti-tumour activity of NXP800, coupled with the data from the Phase Ia dose escalation study, led to the design of the Phase Ib study, including the definition of the patient population and selection of doses and dosing schedules.

“Based on the totality of the data generated to date, we believe that NXP800 has the potential to become an effective treatment for patients with platinum-resistant, ARID1a-mutated ovarian carcinoma, as well as additional target tumour types, which we plan to also investigate in the near term.”