Phase 1 Study of Oral NKT5097 for Adults with Advanced or Metastatic Solid Tumors Including HR HER2- Breast Cancer and CCNE1 Amplified Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of NKT5097, a novel oral drug that selectively degrades CDK2 and CDK4 proteins, in adults with advanced or metastatic solid tumors. The study focuses especially on breast cancer types and tumors with CCNE1 amplification. This Phase 1, open-label trial aims to determine the recommended dose for NKT5097 as both a single drug and combined with endocrine therapy ET, while monitoring participant symptoms and medical issues during treatment. The study is divided into multiple parts initial dose escalation of NKT5097 alone in patients with certain solid tumors evaluation of food effects on drug absorption tumor-specific dose expansion cohorts dose escalation and expansion of NKT5097 combined with ET in hormone receptor-positiveHER2-negative breast cancer. NKT5097 is given orally once or twice daily, while ET drugs like fulvestrant injection and letrozole oral are dosed on specific schedules. Dose levels and combinations may be adjusted based on safety and pharmacokinetic results. Participants will undergo screening and treatment periods lasting up to several years, including safety monitoring for 28 days after the first dose and treatment follow-up up to 2 years or longer. Researchers will assess side effects, drug levels in blood, tumor responses, progression-free survival, and duration of response using recognized criteria. Tumor tissue samples and biomarker tests will be collected to understand drug effects. The study is sponsored by NiKang Therapeutics, Inc.

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors