Clinical trial NCT07011186: A Clinical Trial of TQB3909 Tablets in Combination With Azacitidine for the Treatment of Myeloid Malignancies
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Myeloid Malignancy
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-08
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Incidence and severity of adverse events (AE) and serious adverse events (SAE), abnormal laboratory parameters
timeFrame: Up to 24 weeks
measure: Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Acute Myeloid Leukemia: Investigator-Assessed Objective Response Rate (ORR)
timeFrame: Up to 4 weeks
measure: Myelodysplastic Syndromes: Investigator-Assessed Objective Response Rate (ORR)
timeFrame: Up to 4 weeks
measure: Acute Myeloid Leukemia: Complete Remission + Complete Remission with Incomplete Hematologic Recovery (CR+CRi) Rate
timeFrame: Up to 4 weeks
measure: Acute Myeloid Leukemia: Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate
timeFrame: Up to 4 weeks
measure: Acute Myeloid Leukemia and Myelodysplastic Syndromes: Complete Remission (CR) Rate
timeFrame: Up to 4 weeks
measure: Acute Myeloid Leukemia: Duration of Remission (DOR)
timeFrame: Up to 4 weeks
measure: Acute Myeloid Leukemia: Duration of CR + CRh (DOCR+CRh)
timeFrame: Up to 4 weeks
measure: Acute Myeloid Leukemia: Duration of Complete Remission (DOCR)
timeFrame: Up to 4 weeks
measure: Acute Myeloid Leukemia: Time to First Complete Remission (TTCR)
timeFrame: Up to 4 weeks
measure: Acute Myeloid Leukemia: Time to First Complete Remission (TTCR)
timeFrame: Up to 4 weeks
measure: Acute Myeloid Leukemia and Myelodysplastic Syndromes: Event-Free Survival (EFS)
timeFrame: Up to 4 weeks
measure: Acute Myeloid Leukemia and Myelodysplastic Syndromes: Overall Survival (OS)
timeFrame: Up to 60 weeks
measure: Myelodysplastic Syndromes: Hematologic Improvement (HI) Rate
timeFrame: Up to 4 weeks
measure: Myelodysplastic Syndromes: Transfusion Independence Rate
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical University
state: Anhui
city: Beijing
country: China
facility: Beijing Chaoyang Hospital Affiliated to Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
city: Chengde
country: China
facility: Affiliated Hospital of Chengde Medical University
state: Hebei
city: Harbin
country: China
facility: Harbin The First Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospita
state: Hunan
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiao Tong University
state: Shaanxi
city: Taian
country: China
facility: Tai'an Central Hospital (Tai'an Central Hospital affiliated to Qingdao University, Mount Taishan Medical Center)
state: Shandong
city: Zibo
country: China
facility: Zibo Central Hospital
state: Shandong
city: Shanghai
country: China
facility: ShangHai Tongren Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong New Area People's Hospital
state: Shanghai
city: Deyang
country: China
facility: People's hospital of deyang city
state: Sichuan
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
state: Tianjin
city: Tianjin
country: China
facility: People's Hospital of Tianjin (City)
state: Tianjin
city: Urumqi
country: China
facility: The First Affiliated Hospital of Xinjiang Medical University
state: Xinjiang
city: Ningbo
country: China
facility: The First Affiliated Hospital of Ningbo University
state: Zhejiang
Study officials:
References: