Phase 1 Study of NTQ2494 Tablets to Assess Safety and Effects in Adults With Advanced Blood Cancers

What this Trial Is About

Researchers are evaluating NTQ2494 tablet, a drug that targets AXL kinase, in patients with advanced blood cancers, specifically relapsed or refractory acute myeloid leukemia AML. This phase 1 clinical trial aims to assess the safety, tolerability, pharmacokinetics, and preliminary effectiveness of NTQ2494 in this patient group. The study is sponsored by Nanjing Chia-tai Tianqing Pharmaceutical and focuses on understanding the drugs effects in a controlled setting. The trial involves two parts an initial dose escalation phase where single and multiple doses of NTQ2494 tablets are given with adjustments based on how well patients tolerate the drug, followed by a dose expansion phase using recommended doses from the first phase. Each treatment cycle lasts 28 days, during which multiple doses of NTQ2494 tablets are taken orally. This approach helps determine the best dosing strategy for patients. Participants will undergo regular evaluations including safety and tolerability assessments, pharmacokinetic measurements such as drug concentration over time, and preliminary efficacy checks. The primary outcome is to identify the maximum tolerated dose and any dose-limiting toxicities within 30 days. Secondary outcomes include detailed pharmacokinetic parameters and response rates tracked over about one year. The overall participation duration varies with continued monitoring for safety and treatment response.

A Phase 1 Clinical Trail of NTQ2494 Tablets in Patients With Advanced Hematological Malignancies