RecruitingPhase 1NCT06550713

A Clinical Trial of TQB3455 Tablets in Patients With Hematological Malignancies

Phase I Clinical Trial Protocol for Tolerability and Pharmacokinetics of TQB3455 Tablets in Patients With Hematological Malignancies


Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Enrollment

100 participants

Start Date

Oct 22, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a clinical trial to evaluate the tolerability and pharmacokinetics of TQB3455 tablets in patients with hematological malignancies. TQB3455 is an isocitrate dehydrogenase 2(IDH2) inhibitor . This project is divided into two stages. The first stage aims to evaluate the safety and tolerability of single or multiple oral administration of TQB3455 tablets in subjects with malignant hematological tumors. The second phase aims to evaluate the efficacy and safety of TQB3455 tablets alone or in combination with azacitidine in subjects with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase trial is testing a new drug called TQB3455 tablets in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) — serious blood cancers where the bone marrow produces abnormal blood cells. The study is evaluating both TQB3455 alone and in combination with other drugs to determine safety, dosing, and early signs of effectiveness. **You may be eligible if...** - You are 18 years of age or older - You have been diagnosed with AML that has relapsed (come back) or is refractory (not responding), OR - You are newly diagnosed with AML but are not considered a candidate for standard intensive chemotherapy due to age, physical condition, or risk factors, OR - You have high-risk or very high-risk MDS based on standard scoring - Your organ function meets the required levels **You may NOT be eligible if...** - You have active serious infections - You have had a recent organ or stem cell transplant - You are pregnant or breastfeeding - Your organ function is too impaired to tolerate the treatment 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

DRUGTQB3455 tablet+Azacitidine for Injection

TQB3455 is a selective IDH2 mutant enzyme inhibitor. Azacitidine for injection is a cytosine nucleoside drug that is used for demethylation therapy.


Locations(7)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Peking University international Hospital

Beijing, Beijing Municipality, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin The First Hospital

Harbin, Heilongjiang, China

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

People's Hospital of Tianjin

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06550713


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