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Clinical Trials in China / NCT07011186
Recruiting Phase 1/2

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

NCT07011186 · tracked via the Priya Life Science China tracker
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase
Phase 1/2
Started
2024-04-17
Last updated
2025-06-08

Condition(s) studied

Myeloid Malignancy

Investigational drug(s) / intervention(s)

TQB3909 Tablets + Azacitidine

TQB3909 Tablets + Azacitidine: TQB3909 is a protein inhibitor; Azacitidine is a cytidine nucleoside analogue

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Voluntary and signed informed consent, good compliance * Age: ≥18 years old (at the time of signing the informed consent); expected survival time greater than 3 months. * Diagnosis of one of the following diseases: 1. Acute Myeloid Leukemia (AML): 2. Myelodysplastic Syndromes (MDS) 3. Major organ functions are normal. 4. Fertile male and female subjects agree to use contraception during the study and for 6 months after the study ends. Exclusion Criteria: * Comorbidities and Medical History: 1. Diagnosis of or current concomitant malignancy within 3 years prior to the first dose; 2. Presence of multiple factors affecting oral drug intake and/or absorption; 3. Major surgical procedures or significant traumatic injuries within 28 days prior to the first dose; 4. History of arterial/venous thrombotic events within 6 months prior to the first dose; 5. History of psychiatric drug abuse that cannot be discontinued, or psychiatric disorders; 6. Presence of any severe and/or uncontrolled disease in the subject. * Tumor-related Symptoms and Treatment: 1. Diagnosis of Acute Promyelocytic Leukemia (APL), Myelodysplastic Syndromes/Myeloproliferative Neoplasms (MDS/MPN); 2. Presence of leukemia central nervous system (CNS) involvement or high suspicion of CNS involvement but unable to confirm; 3. Subjects with extramedullary disease only in AML; 4. Presence of life-threatening severe leukemia-related complications; * Study Treatment-related: 1. Received live vaccines within 4 weeks prior to the first dose, or planned to receive live vaccines during the study period; 2. Participated in other clinical trials involving anti-tumor drugs within 4 weeks prior to the first dose.

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical University Bengbu Anhui Not Yet Recruiting
Beijing Chaoyang Hospital Affiliated to Capital Medical University Beijing Beijing Municipality Not Yet Recruiting
Peking University People's Hospital Beijing Beijing Municipality Not Yet Recruiting
Beijing Tsinghua Changgung Hospital Beijing Beijing Municipality Not Yet Recruiting
Affiliated Hospital of Chengde Medical University Chengde Hebei Not Yet Recruiting
Harbin The First Hospital Harbin Heilongjiang Not Yet Recruiting
Henan Provincial People's Hospital Zhengzhou Henan Not Yet Recruiting
Zhongnan Hospital of Wuhan University Wuhan Hubei Not Yet Recruiting
Zhuzhou Central Hospita Zhuzhou Hunan Not Yet Recruiting
Shengjing Hospital of China Medical University Shenyang Liaoning Not Yet Recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University Xi'an Shaanxi Not Yet Recruiting
Tai'an Central Hospital (Tai'an Central Hospital affiliated to Qingdao University, Mount Taishan Medical Center) Taian Shandong Not Yet Recruiting
Zibo Central Hospital Zibo Shandong Not Yet Recruiting
ShangHai Tongren Hospital Shanghai Shanghai Municipality Recruiting
Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital Shanghai Shanghai Municipality Not Yet Recruiting
Shanghai Pudong New Area People's Hospital Shanghai Shanghai Municipality Not Yet Recruiting
People's hospital of deyang city Deyang Sichuan Not Yet Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Tianjin Tianjin Municipality Not Yet Recruiting
People's Hospital of Tianjin (City) Tianjin Tianjin Municipality Not Yet Recruiting
The First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang Not Yet Recruiting
The First Affiliated Hospital of Ningbo University Ningbo Zhejiang Not Yet Recruiting

More Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07011186 on ClinicalTrials.gov ↗ ← All trials in China