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Recruiting NCT07011186

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

Phase I / Phase II Interventional Myeloid Malignancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TQB3909 Tablets + Azacitidine.
Who it may be relevant to
Registry conditions: Myeloid Malignancy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

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

Primary outcome measures

  • Incidence and severity of adverse events (AE) and serious adverse events (SAE), abnormal laboratory parameters [Time frame: Up to 24 weeks]
  • Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate [Time frame: Up to 4 weeks]
Secondary outcome measures (12)
  • Acute Myeloid Leukemia: Investigator-Assessed Objective Response Rate (ORR) [Time frame: Up to 4 weeks]
  • Myelodysplastic Syndromes: Investigator-Assessed Objective Response Rate (ORR) [Time frame: Up to 4 weeks]
  • Acute Myeloid Leukemia: Complete Remission + Complete Remission with Incomplete Hematologic Recovery (CR+CRi) Rate [Time frame: Up to 4 weeks]
  • Acute Myeloid Leukemia: Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate [Time frame: Up to 4 weeks]
  • Acute Myeloid Leukemia and Myelodysplastic Syndromes: Complete Remission (CR) Rate [Time frame: Up to 4 weeks]
  • Acute Myeloid Leukemia: Duration of Remission (DOR) [Time frame: Up to 4 weeks]
  • Acute Myeloid Leukemia: Duration of CR + CRh (DOCR+CRh) [Time frame: Up to 4 weeks]
  • Acute Myeloid Leukemia: Duration of Complete Remission (DOCR) [Time frame: Up to 4 weeks]
  • Acute Myeloid Leukemia: Time to First Complete Remission (TTCR) [Time frame: Up to 4 weeks]
  • Acute Myeloid Leukemia: Time to First Complete Remission (TTCR) [Time frame: Up to 4 weeks]
  • Acute Myeloid Leukemia and Myelodysplastic Syndromes: Event-Free Survival (EFS) [Time frame: Up to 4 weeks]
  • Acute Myeloid Leukemia and Myelodysplastic Syndromes: Overall Survival (OS) [Time frame: Up to 60 weeks]

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:
  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 21 centers
  • The First Affiliated Hospital of Bengbu Medical University — Bengbu
  • Beijing Chaoyang Hospital Affiliated to Capital Medical University — Beijing
  • Peking University People's Hospital — Beijing
  • Beijing Tsinghua Changgung Hospital — Beijing
  • Affiliated Hospital of Chengde Medical University — Chengde
  • Harbin The First Hospital — Harbin
  • Henan Provincial People's Hospital — Zhengzhou
  • Zhongnan Hospital of Wuhan University — Wuhan
  • … and 13 more centers

Identifiers

NCT: NCT07011186 · TQB3909-Ib/II-03

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗