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

Phase 1

Recruiting

• Conditions: Myeloid Malignancy
• Interventions: Drug: TQB3909 Tablets + Azacitidine

• Registration Number: NCT07011186
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-17
• Status Verified: 2025-03
• Study First Submitted: 2025-05-21
• Study First Submitted QC: 2025-05-30
• Last Update Submitted: 2025-05-30
• Study First Posted: 2025-06-08
• Last Update Posted: 2025-06-08
• Primary Completion: 2025-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 138

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TQB3909 Tablets + Azacitidine	TQB3909 Tablets + Azacitidine	TQB3909 Tablets administered once-daily. 28 days as a treatment cycle.

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events (AE) and serious adverse events (SAE), abnormal laboratory parameters	Up to 24 weeks	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)
Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate	Up to 4 weeks	Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate

Secondary Outcome Measures

Name	Time	Method
Acute Myeloid Leukemia: Investigator-Assessed Objective Response Rate (ORR)	Up to 4 weeks	Proportion of subjects with best response as Complete Remission (CR), Complete Remission with Incomplete Hematologic Recovery (CRi), Morphologic Leukemia-Free State (MLFS), or Partial Remission (PR)
Myelodysplastic Syndromes: Investigator-Assessed Objective Response Rate (ORR)	Up to 4 weeks	Proportion of subjects with best response as CR, Morphological Complete Remission (mCR), or PR
Acute Myeloid Leukemia: Complete Remission + Complete Remission with Incomplete Hematologic Recovery (CR+CRi) Rate	Up to 4 weeks	Proportion of subjects with best response as CR+CRi. CRi refers to meeting all CR criteria except for residual neutrophil count decrease (ANC \< 1.0 × 109/L) or platelet count decrease (PLT \< 100 × 109/L).
Acute Myeloid Leukemia: Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate	Up to 4 weeks	Proportion of subjects with best response as CR
Acute Myeloid Leukemia: Duration of CR + CRh (DOCR+CRh)	Up to 4 weeks	For all subjects with best response as CR or CRh, the time from the first date of achieving CR or CRh to the first recorded date of relapse or death (whichever occurs first).
Acute Myeloid Leukemia: Duration of Complete Remission (DOCR)	Up to 4 weeks	For all subjects with best response as CR, the time from the first date of achieving CR to the first recorded date of relapse or death (whichever occurs first).
Acute Myeloid Leukemia: Time to First Complete Remission (TTCR)	Up to 4 weeks	For subjects with best response as CR, the time from the first date of medication to the first date of CR.
Acute Myeloid Leukemia and Myelodysplastic Syndromes: Event-Free Survival (EFS)	Up to 4 weeks	Defined as the duration from the first dose of medication to treatment failure, relapse after CR or CRi, or death due to any cause (whichever occurs first). Treatment failure is defined as not achieving CR or CRi at any assessment time during treatment. Subjects with treatment failure will be considered to have an EFS event on the first day after the first dose. For subjects with CR or CRi, the event time will be the time of disease relapse or death (whichever occurs first).
Acute Myeloid Leukemia and Myelodysplastic Syndromes: Overall Survival (OS)	Up to 60 weeks	The time from the first dose of medication to the date of death due to any cause.
Myelodysplastic Syndromes: Hematologic Improvement (HI) Rate	Up to 4 weeks	Proportion of subjects meeting Hematologic Improvement (HI) criteria, including Hematologic Improvement - Erythrocyte (HI-E), Hematologic Improvement - Platelet (HI-P), and Hematologic Improvement - Neutrophil (HI-N).
Myelodysplastic Syndromes: Transfusion Independence Rate	Up to 8 weeks	The proportion of subjects who did not require transfusions for at least 56 days after baseline, relative to the number of baseline transfusion-dependent and transfusion-independent subjects.
Acute Myeloid Leukemia and Myelodysplastic Syndromes: Complete Remission (CR) Rate	Up to 4 weeks	Proportion of subjects with best response as CR
Acute Myeloid Leukemia: Duration of Remission (DOR)	Up to 4 weeks	For all subjects with best response as CR, CRi, MLFS, or PR, the time from the first date of achieving remission to the first recorded date of disease progression, relapse, or death (whichever occurs first).

Trial Locations

Locations (21)

The First Affiliated Hospital of Bengbu Medical University; 🇨🇳 Bengbu, Anhui, China

Beijing Chaoyang Hospital Affiliated to Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Tsinghua Changgung Hospital; 🇨🇳 Beijing, Beijing, 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

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