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
1 other identifier
interventional
138
1 country
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2024
Typical duration for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 17, 2024
CompletedFirst Submitted
Initial submission to the registry
May 21, 2025
CompletedFirst Posted
Study publicly available on registry
June 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedJune 8, 2025
March 1, 2025
1.5 years
May 21, 2025
May 30, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Incidence and severity of adverse events (AE) and serious adverse events (SAE), abnormal laboratory parameters
Any adverse medical event that occurred from the time the subject signed the informed consent until 28 days after the last dose/start of the new antitumor therapy (whichever occurs first)
Up to 24 weeks
Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate
Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate
Up to 4 weeks
Secondary Outcomes (14)
Acute Myeloid Leukemia: Investigator-Assessed Objective Response Rate (ORR)
Up to 4 weeks
Myelodysplastic Syndromes: Investigator-Assessed Objective Response Rate (ORR)
Up to 4 weeks
Acute Myeloid Leukemia: Complete Remission + Complete Remission with Incomplete Hematologic Recovery (CR+CRi) Rate
Up to 4 weeks
Acute Myeloid Leukemia: Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate
Up to 4 weeks
Acute Myeloid Leukemia and Myelodysplastic Syndromes: Complete Remission (CR) Rate
Up to 4 weeks
- +9 more secondary outcomes
Study Arms (1)
TQB3909 Tablets + Azacitidine
EXPERIMENTALTQB3909 Tablets administered once-daily. 28 days as a treatment cycle.
Interventions
TQB3909 is a protein inhibitor; Azacitidine is a cytidine nucleoside analogue
Eligibility Criteria
You may qualify if:
- 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:
- Acute Myeloid Leukemia (AML):
- Myelodysplastic Syndromes (MDS)
- Major organ functions are normal.
- Fertile male and female subjects agree to use contraception during the study and for 6 months after the study ends.
You may not qualify if:
- Comorbidities and Medical History:
- Diagnosis of or current concomitant malignancy within 3 years prior to the first dose;
- Presence of multiple factors affecting oral drug intake and/or absorption;
- Major surgical procedures or significant traumatic injuries within 28 days prior to the first dose;
- History of arterial/venous thrombotic events within 6 months prior to the first dose;
- History of psychiatric drug abuse that cannot be discontinued, or psychiatric disorders;
- Presence of any severe and/or uncontrolled disease in the subject.
- Tumor-related Symptoms and Treatment:
- Diagnosis of Acute Promyelocytic Leukemia (APL), Myelodysplastic Syndromes/Myeloproliferative Neoplasms (MDS/MPN);
- Presence of leukemia central nervous system (CNS) involvement or high suspicion of CNS involvement but unable to confirm;
- Subjects with extramedullary disease only in AML;
- Presence of life-threatening severe leukemia-related complications;
- Study Treatment-related:
- Received live vaccines within 4 weeks prior to the first dose, or planned to receive live vaccines during the study period;
- Participated in other clinical trials involving anti-tumor drugs within 4 weeks prior to the first dose.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233000, China
Beijing Chaoyang Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 100020, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, 67020, China
Harbin The First Hospital
Harbin, Heilongjiang, 150010, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071, China
Zhuzhou Central Hospita
Zhuzhou, Hunan, 412007, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710000, China
Tai'an Central Hospital (Tai'an Central Hospital affiliated to Qingdao University, Mount Taishan Medical Center)
Taian, Shandong, 271099, China
Zibo Central Hospital
Zibo, Shandong, 255036, China
ShangHai Tongren Hospital
Shanghai, Shanghai Municipality, 200000, China
Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital
Shanghai, Shanghai Municipality, 200437, China
Shanghai Pudong New Area People's Hospital
Shanghai, Shanghai Municipality, 201200, China
People's hospital of deyang city
Deyang, Sichuan, 618099, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, 300020, China
People's Hospital of Tianjin (City)
Tianjin, Tianjin Municipality, 300122, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2025
First Posted
June 8, 2025
Study Start
April 17, 2024
Primary Completion
October 1, 2025
Study Completion (Estimated)
October 1, 2026
Last Updated
June 8, 2025
Record last verified: 2025-03