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.
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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.
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By GlobalDataThe 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.
