NCT07011186RecruitingPhase 1
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
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.21 sites in 1 country138 target enrollmentStarted: April 17, 2024Last updated:
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 138
- Locations
- 21
- Primary Endpoint
- Incidence and severity of adverse events (AE) and serious adverse events (SAE), abnormal laboratory parameters
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
TQB3909 Tablets + Azacitidine
Experimental
TQB3909 Tablets administered once-daily. 28 days as a treatment cycle.
Intervention: TQB3909 Tablets + Azacitidine (Drug)
Outcomes
Primary Outcomes
Incidence and severity of adverse events (AE) and serious adverse events (SAE), abnormal laboratory parameters
Time Frame: 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
Time Frame: Up to 4 weeks
Complete Remission + Complete Remission with Partial Hematologic Recovery (CR+CRh) Rate
Secondary Outcomes
- 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)
- Acute Myeloid Leukemia: Duration of Remission (DOR)(Up to 4 weeks)
- Acute Myeloid Leukemia: Duration of CR + CRh (DOCR+CRh)(Up to 4 weeks)
- Acute Myeloid Leukemia: Duration of Complete Remission (DOCR)(Up to 4 weeks)
- Acute Myeloid Leukemia: Time to First Complete Remission (TTCR)(Up to 4 weeks)
- Acute Myeloid Leukemia and Myelodysplastic Syndromes: Event-Free Survival (EFS)(Up to 4 weeks)
- Acute Myeloid Leukemia and Myelodysplastic Syndromes: Overall Survival (OS)(Up to 60 weeks)
- Myelodysplastic Syndromes: Hematologic Improvement (HI) Rate(Up to 4 weeks)
- Myelodysplastic Syndromes: Transfusion Independence Rate(Up to 8 weeks)
Investigators
Study Sites (21)
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