RecruitingPhase 1Phase 2NCT07011186

A Clinical Trial of TQB3909 Tablets in Combination With Azacitidine for the Treatment of Myeloid Malignancies

A Phase Ib/II Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of TQB3909 Tablets in Combination With Azacitidine in Subjects With Myeloid Malignancies


Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Enrollment

138 participants

Start Date

Apr 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open, multi-center clinical study designed to evaluate the safety, tolerability and efficacy of TQB3909 tablets in combination with azacitidine in subjects with myeloid malignancies.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called TQB3909 combined with azacitidine (a chemotherapy drug) for people with blood cancers including acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) — conditions where the bone marrow does not produce healthy blood cells properly. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of AML or MDS - Your kidneys, liver, and bone marrow are functioning adequately - You are willing to use contraception during the study and for 6 months after **You may NOT be eligible if...** - You have another serious health condition that is not well-controlled - You have had a recent stem cell transplant - You are pregnant or breastfeeding - You have active infections 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

DRUGTQB3909 Tablets + Azacitidine

TQB3909 is a protein inhibitor; Azacitidine is a cytidine nucleoside analogue


Locations(21)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Beijing Chaoyang Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Affiliated Hospital of Chengde Medical University

Chengde, Hebei, China

Harbin The First Hospital

Harbin, Heilongjiang, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Zhuzhou Central Hospita

Zhuzhou, Hunan, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, China

Tai'an Central Hospital (Tai'an Central Hospital affiliated to Qingdao University, Mount Taishan Medical Center)

Taian, Shandong, China

Zibo Central Hospital

Zibo, Shandong, China

ShangHai Tongren Hospital

Shanghai, Shanghai Municipality, China

Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pudong New Area People's Hospital

Shanghai, Shanghai Municipality, China

People's hospital of deyang city

Deyang, Sichuan, China

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Tianjin, Tianjin Municipality, China

People's Hospital of Tianjin (City)

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07011186


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