Spots Global Cancer Trial Database for A Study of BN104 in the Treatment of Acute Leukemia
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Trial Identification
Brief Title: A Study of BN104 in the Treatment of Acute Leukemia
Official Title: A PhaseI/II, Multicenter, Open-label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of the Menin Inhibitor BN104 in the Treatment of Patients With Relapsed/Refractory Acute Leukemia
Study ID: NCT06052813
Interventions
Study Description
Brief Summary: The Phase I/II trial is to learn the safety, pharmacokinetics, and preliminary efficacy of BN104 taken once daily or twice daily in patients with acute lymphocytic leukemia or acute myeloblastic leukemia.
Detailed Description: The study is divided into 2 phases. Phase1 dose escalation part will enroll 19-42 patients to evaluate safety and tolerance of BN104 in patients with relapsed/refractory (R/R) Acute Leukemia to determine maximum tolerated dose and recommended phase2 dose (RP2D), including 10-12 patient with specific mutations (KMT2A gene rearrangement or NPM1 gene mutation) enrolled at dose optimization phase. Phase II expansion part will enroll 30-48 patients and be conducted at the selected dose level to further evaluate the safety and tolerability of BN104, as well as preliminary efficacy in Acute leukemia subjects with specific mutations (KMT2A gene rearrangement or NPM1 gene mutation). Patients will be allocated into 3 Acute Leukemia subgroup cohorts depends on their genotype. * Cohort A: Subjects with Relapsed/refractory AML subjects with NPM1 mutations * Cohort B: Subjects with relapsed/refractory AML with KMT2A rearrangements. * Cohort C: Subjects with relapsed/refractory ALL or mixed spectrum leukemia with KMT2A rearrangements Patients will receive orally administrated BN104 once daily or twice daily. Study drug will be administered in 28-day cycles until disease progression or unacceptable toxicity, death, Informed consent withdraw ect. Laboratory tests will be performed weekly in Cycles 1-2, bi-weekly in Cycle3 and every 4weeks from Cycle 4 onwards. Efficacy assessment will be performed on baseline, C2D1, C3D1 and every 2 cycles from Cycle3 onwards. Additional clinical assessments and laboratory tests may be performed at discretion of the investigator as clinically indicated.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The First Affiliated Hospital of Soochow University, Suzhou, , China
Contact Details
Name: Depei WU, Prof.
Affiliation: The First Affiliated Hospital of Soochow University
Role: PRINCIPAL_INVESTIGATOR
Name: Mingyuan Li, Dr.
Affiliation: Institute of Hematology, Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Yan Li, Dr.
Affiliation: Institute of Hematology, Chinese Academy of Medical Sciences
Role: PRINCIPAL_INVESTIGATOR
Name: Xudong Wei, Prof.
Affiliation: Henan Oncology Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Dengju Li, Prof.
Affiliation: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Role: PRINCIPAL_INVESTIGATOR
Name: Yuhua Li, Prof.
Affiliation: Southern Medical University, China
Role: PRINCIPAL_INVESTIGATOR
Name: Xiaoyu Zhu, Prof.
Affiliation: Anhui Provinvcal Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Fei Li, Prof.
Affiliation: The First Affiliated Hospital of Nanchang University
Role: PRINCIPAL_INVESTIGATOR
Name: Xiaoqing Yan, Prof.
Affiliation: First Hospital of China Medical University
Role: PRINCIPAL_INVESTIGATOR
Name: Jinhai Ren, Prof.
Affiliation: The Second Hospital of Hebei Medical University
Role: PRINCIPAL_INVESTIGATOR
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