Nuvectis Pharma has released preliminary findings from the ongoing Phase Ib clinical trial of NXP800, aimed at treating patients with platinum-resistant ARID1a-mutated ovarian cancer.

The trial, which is currently underway in leading clinical centres across the US and UK, is a collaborative effort with the European Network of Gynecological Oncological Trial Groups and the GOG Foundation.

It focuses on assessing the safety and initial efficacy of NXP800 in this specific group of patients.

The multicentre, single-arm, open-label trial enrolled patients who have shown resistance to platinum-based chemotherapy, a common treatment for ovarian cancer.

Encouraging preliminary efficacy data was derived from the first four participants in the trial.

According to the findings, one patient on the 75mg/day dosage achieved a partial response (PR), with a complete response (CR) in her non-target lymph node disease, although this PR remains unconfirmed.

The two patients on the 50mg/day dosage both achieved stable disease (SD) while the fourth patient's efficacy was not evaluated.

The trial also reported safety concerns, with three patients experiencing Grade 4 thrombocytopenia, although these adverse events were transient and did not result in bleeding.

Following these incidents, the trial has implemented a management procedure for monitoring platelets and making dose adjustments as required.

No Grade 3 haematological toxicities were seen with gastrointestinal adverse events, all Grade 1-2, observed in all four trial subjects.

Nuvectis chairman and CEO Ron Bentsur said: “We are pleased to share the preliminary results from the NXP800 Phase 1b study in the target patient population of platinum-resistant, ARID1a-mutated ovarian cancer patients.

“The clinical activity observed thus far includes a 33% response rate and 100% disease control rate, defined as partial response plus stable disease, in patients evaluated for efficacy.

“While the data presented today is early, we are encouraged by the achievement of a PR as well as a complete response of the non-target lymph node disease in a patient with a progressive malignancy after a surgical resection and two prior lines of systemic combination chemotherapy, and stable disease in patients with similar stage disease.”

Last September, the company initiated a Phase Ia trial of NXP900 to treat solid tumours.