RecruitingPhase 1Phase 2NCT07011186
A Clinical Trial of TQB3909 Tablets in Combination With Azacitidine for the Treatment of Myeloid Malignancies
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
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment
138 participants
Start Date
Apr 17, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria7
- 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 Criteria15
- 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.
Interventions
DRUGTQB3909 Tablets + Azacitidine
TQB3909 is a protein inhibitor; Azacitidine is a cytidine nucleoside analogue
Locations(21)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07011186
Related Trials
Trial of Novel Anti-leukemia Agents in Flu/Mel RIC Transplant for Myeloid Malignancies
NCT070445441 location
A Telehealth Advance Care Planning Intervention
NCT058758051 location
Study of Lisaftoclax (APG-2575) Single Agent and Combination With Therapy in Patients Relapsed/Refractory AML
NCT0450112012 locations
Mitoxantrone Hydrochloride Liposome, Standard-dose of Cytarabine and Venetoclax in the Treatment of R/R AML
NCT066212121 location
Decitabine and Venetoclax Treatment as Maintenance Therapy in Patients Post Allograft Stem Cell Transplant
NCT061297341 location