RecruitingPhase 1NCT06049667

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

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics and Preliminary Efficacy of NTQ2494 Tablets in Patients With Advanced Hematological Malignancies


Sponsor

Nanjing Chia-tai Tianqing Pharmaceutical

Enrollment

72 participants

Start Date

Aug 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

NTQ2494 tablet, an anti-tumor molecular targeted drug, is an AXL kinase inhibitor. The objectives were to evaluate the safety and tolerability, PK characteristics and preliminary efficacy of NTQ2494 tablets in patients with advanced hematological malignancies.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a new oral drug called NTQ2494 in patients with a blood cancer called acute myeloid leukemia (AML) that has returned or stopped responding to prior treatment. The study focuses on safety and finding the right dose. **You may be eligible if...** - You are 18 or older - You have relapsed or treatment-resistant AML - You are in reasonably good overall health and can care for yourself - You have a life expectancy of at least 3 months - Your bone marrow and major organs are functioning adequately **You may NOT be eligible if...** - You received cancer treatment, immunotherapy, or radiation in the past 2 weeks (or within 5 drug half-lives) - You participated in another clinical trial in the past 4 weeks - You had major surgery in the past 4 weeks - You have active hepatitis B or C, HIV, or active serious infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNTQ2494 tablet

Drug: NTQ2494 tablet Part 1: Dose escalation, single and multiple doses of NTQ2494 with dose modifications based on tolerability criteria. For each dose level, a single dose of NTQ2494 tablets will be first administered orally, then continuous 28-day treatment will start (per cycle). Part 2: Dose expansion, recommended doses from Part 1. For each dose level, multiple doses of NTQ2494 tablets will be administered as 28-day treatment (per cycle).


Locations(1)

Hematology Hospital of the Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

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NCT06049667


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