Phase 1 Study of Oral NXP900 for Adults with Advanced Solid Tumors Including Lung, Renal Cancer, and Mesothelioma

What this Trial Is About

Researchers are conducting a multi-center, first-in-human, open-label Phase 1 study to evaluate NXP900, an oral SRCYES1 kinase inhibitor, in adults with advanced solid tumors. The study focuses on patients with advanced cancers, including lung, renal cancer, mesothelioma, and tumors with specific genetic alterations such as YES1 amplification or Hippo pathway-related mutations. It aims to assess safety, dosage, and preliminary effectiveness of NXP900 in these patients. The study has two parts Part A is a dose escalation phase starting at 20 mg once daily, where participants receive increasing doses of NXP900 to find a suitable dose. Part B is a dose expansion phase where participants with tumors harboring specific genetic markers receive a selected dose of NXP900. Treatments are administered orally, and the study includes both patients with advanced solid tumors without effective therapies and those with tumors having certain pathogenic molecular alterations. Participants will undergo regular assessments including monitoring for treatment-related side effects, clinical laboratory tests, and tumor response evaluations using RECIST criteria. Safety evaluations occur up to 30 days post-treatment, while efficacy measures such as objective response rate, duration of response, and disease control rate are followed for up to 24 months. Pharmacokinetic testing tracks how the drug is absorbed and processed. The total study duration extends to July 2027, with ongoing monitoring of patient health and treatment effects.

A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers