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

CTTQ

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

Myeloid Malignancy

Treatments

Drug: TQB3909 Tablets + Azacitidine

Study type

Interventional

Funder types

Industry

Identifiers

NCT07011186

TQB3909-Ib/II-03

Details and patient eligibility

About

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.

Enrollment

138 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.