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

Phase 2RecruitingNCT07011186

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.138 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

138

Conditions

Myeloid Malignancy

Interventions

TQB3909 Tablets + AzacitidineDRUG

TQB3909 is a protein inhibitor; Azacitidine is a cytidine nucleoside analogue

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (21)

Outcomes

Primary Outcomes

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)

Time frame: Up to 24 weeks

Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate

Time frame: Up to 4 weeks

Secondary Outcomes

Acute Myeloid Leukemia: Investigator-Assessed Objective Response Rate (ORR)

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)

Time frame: Up to 4 weeks

Myelodysplastic Syndromes: Investigator-Assessed Objective Response Rate (ORR)

Proportion of subjects with best response as CR, Morphological Complete Remission (mCR), or PR

Time frame: Up to 4 weeks

Acute Myeloid Leukemia: Complete Remission + Complete Remission with Incomplete Hematologic Recovery (CR+CRi) Rate

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).

Time frame: Up to 4 weeks

Acute Myeloid Leukemia: Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate

Proportion of subjects with best response as CR

Central Contacts

JianXiang Wang, Master

CONTACT

13821389157 wangjx@ihcams.ac.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

NOT_YET_RECRUITING

Beijing Chaoyang Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

NOT_YET_RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, China

NOT_YET_RECRUITING

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

NOT_YET_RECRUITING

Affiliated Hospital of Chengde Medical University

Chengde, Hebei, China

NOT_YET_RECRUITING

Harbin The First Hospital

Harbin, Heilongjiang, China

NOT_YET_RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

NOT_YET_RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

NOT_YET_RECRUITING

Zhuzhou Central Hospita

Zhuzhou, Hunan, China

NOT_YET_RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

NOT_YET_RECRUITING

...and 11 more locations

Time frame: Up to 4 weeks

Acute Myeloid Leukemia and Myelodysplastic Syndromes: Complete Remission (CR) Rate

Proportion of subjects with best response as CR

Time frame: Up to 4 weeks

Acute Myeloid Leukemia: Duration of Remission (DOR)

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).

Time frame: Up to 4 weeks

Acute Myeloid Leukemia: Duration of CR + CRh (DOCR+CRh)

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).

Time frame: Up to 4 weeks

Acute Myeloid Leukemia: Duration of Complete Remission (DOCR)

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).

Time frame: Up to 4 weeks

Acute Myeloid Leukemia: Time to First Complete Remission (TTCR)

For all subjects with best response as CR or CRh, the time from the first date of medication to the first date of CR or CRh.

Time frame: Up to 4 weeks

Acute Myeloid Leukemia: Time to First Complete Remission (TTCR)

For subjects with best response as CR, the time from the first date of medication to the first date of CR.

Time frame: Up to 4 weeks

Acute Myeloid Leukemia and Myelodysplastic Syndromes: Event-Free Survival (EFS)

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).

Time frame: Up to 4 weeks

Acute Myeloid Leukemia and Myelodysplastic Syndromes: Overall Survival (OS)

The time from the first dose of medication to the date of death due to any cause.

Time frame: Up to 60 weeks

Myelodysplastic Syndromes: Hematologic Improvement (HI) Rate

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).

Time frame: Up to 4 weeks

Myelodysplastic Syndromes: Transfusion Independence Rate

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.

Time frame: Up to 8 weeks