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Recruiting Phase 1, Phase 2 NCT07011186

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

Trial Parameters

Condition Myeloid Malignancy
Sponsor Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 138
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-04-17
Completion 2025-10
Interventions
TQB3909 Tablets + Azacitidine

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.

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: 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/

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