Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Neoplasms by Histologic Type

Hematologic Diseases

Acute Graft Versus Host Disease

The starting dose cohort(200mg QD) where accelerated titrated dose-escalation method is applied, a patient will initially receive a single dose BN104 on Day 1 of Cycle 0 (3 days prior to Day 1 of Cycle 1) to evaluate the concentration of BN104 up to 72 hours after administration and the safety of single dose of BN104. Then the patient begins continuous treatment with BN104 200 mg QD on Day 1 of Cycle 1 by every 28-day treatment cycle until disease progression, intolerable toxicity, withdrawal of consent, loss to follow-up, death, or other conditions in which patients are not suitable for study treatment, whichever occurs first.

After completion of DLT evaluation for the first dose cohort (200 mg QD), patients will begin to receive twice daily (BID) dosing frequency in each 28-day treatment cycle for the subsequent dose cohorts for which conventional 3+3 design is used until disease progression, intolerable toxicity, withdrawal of consent, loss to follow-up, death, or other conditions in which patients are not suitable for study treatment, whichever occurs first.

Will be administered orally once daily (approximately every 24 hours) for the first cohort or twice daily (approximately every 12 hours) for the subsequent cohorts.

BN104

Yolin Pan

Depei Wu

Depei WU, Prof.

Mingyuan Li, Dr.

Yan Li, Dr.

Xudong Wei, Prof.

Dengju Li, Prof.

Yuhua Li, Prof.

Xiaoyu Zhu, Prof.

Fei Li, Prof.

Xiaoqing Yan, Prof.

Jinhai Ren, Prof.

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.

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.

A Study of BN104 in the Treatment of Acute Leukemia

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

DLTs will be evaluated at the end of cycle 1(28 days after receiving BN104) for each dose level by evaluating abnormal laboratory examinations by the Investigator.

SAEs will be recorded in the eCRF from time of the signing informed consent through 30 days after the last dose of BN104.

To assess the preliminary anti-tumor activity of BN104 based on Complete response (CR), Complete response with partial recovery of hematology (CRh), Complete response with incomplete hematological recovery (CRi) assessed by the Investigator

Evaluate the number and frequency of adverse events (AEs) by evaluating abnormal laboratory examinations by the Investigator at each clinical visit from time of the signing informed consent through 30 days after the last dose of BN104.

Evaluate vital signs, including body temperature, heart rate, respiration rate, and blood pressure by the Investigator at each clinical visit before taking BN104.

Evaluate electrocardiogram (ECG) assessments by the Investigator Prior to any examination at each clinical visit to monitor heart rate, R-R interval, QT interval and QTcF interval, QRS, and P-R interval times.

To characterized Maximum Plasma Concentration \[Cmax\] of BN104 by collecting and evaluating the serum at the protocol specified time points.

To characterized Peak time(Tmax) of BN104 by collecting and evaluating the serum at the protocol specified time points

To characterized Clearance half-life (T1/2) of BN104 by collecting and evaluating the serum at the protocol specified time points

To characterized Area under the blood concentration-time curve (AUC0-t) of BN104 by collecting and evaluating the serum at the protocol specified time points.

To characterized BN104 major metabolite M1 by collecting and evaluating the serum at the protocol specified time points.

To assess the preliminary anti-tumor activity of BN104 based on Complete response (CR) assessed by the Investigator at Cycle2. cycle3 and every 2 cycles thereafter through peripheral blood tests, detection of bone marrow primitive cell ratio and other morphological changes by bone marrow aspiration/biopsy

To assess the preliminary anti-tumor activity of BN104 based on Complete response with partial recovery of hematology (CRh) assessed by the Investigator at Cycle2. cycle3 and every 2 cycles thereafter through peripheral blood tests, detection of bone marrow primitive cell ratio and other morphological changes by bone marrow aspiration/biopsy

To assess the preliminary anti-tumor activity of BN104 based on Complete response with incomplete hematological recovery (CRi) assessed by the Investigator at Cycle2. cycle3 and every 2 cycles thereafter through peripheral blood tests, detection of bone marrow primitive cell ratio and other morphological changes by bone marrow aspiration/biopsy

To assess the preliminary anti-tumor activity of BN104 based on Objective response rate (ORR) assessed by the Investigator at Cycle2. cycle3 and every 2 cycles thereafter through peripheral blood tests, detection of bone marrow primitive cell ratio and other morphological changes by bone marrow aspiration/biopsy

To assess the preliminary anti-tumor activity of BN104 based on Duration of response (DOR) assessed by the Investigator at Cycle2. cycle3 and every 2 cycles thereafter through peripheral blood tests, detection of bone marrow primitive cell ratio and other morphological changes by bone marrow aspiration/biopsy

To assess the preliminary anti-tumor activity of BN104 based on Event-free survival (EFS) assessed by the Investigator at Cycle2. cycle3 and every 2 cycles thereafter through peripheral blood tests, detection of bone marrow primitive cell ratio and other morphological changes by bone marrow aspiration/biopsy

To assess the preliminary anti-tumor activity of BN104 based Relapse-free survival (RFS) assessed by the Investigator at Cycle2. cycle3 and every 2 cycles thereafter through peripheral blood tests, detection of bone marrow primitive cell ratio and other morphological changes by bone marrow aspiration/biopsy

To assess the preliminary anti-tumor activity of BN104 based on Overall survival (OS) assessed by the Investigator at Cycle2. cycle3 and every 2 cycles thereafter through peripheral blood tests, detection of bone marrow primitive cell ratio and other morphological changes by bone marrow aspiration/biopsy

To assess the preliminary anti-tumor activity of BN104 based on Cumulative relapse rate (CIR) assessed by the Investigator at Cycle2. cycle3 and every 2 cycles thereafter through peripheral blood tests, detection of bone marrow primitive cell ratio and other morphological changes by bone marrow aspiration/biopsy

Changes in pharmacokinetic biomarkers (e.g., HOXA9, MEIS1, CD11b, etc.) before and after BN104 administration, and correlations with dosing and efficacy

The correlation between specific gene alterations (such as NPM1 mutation, KMT2A rearrangement) and other gene alterations (such as FLT3 mutation/fusion, TP53 mutation, NUP98 fusion, etc.), and clinical efficacy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of BN104 in the Treatment of Acute Leukemia	NCT06052813	ALL, Adult AML, Adult	BN104	18 Years -	BioNova Pharmaceuticals (Shanghai) LTD.
A Study of BN104 in the Treatment of Acute Leukemia	NCT06052813	ALL, Adult AML, Adult	BN104	18 Years -	BioNova Pharmaceuticals (Shanghai) LTD.

Spots Global Cancer Trial Database for bn104

Every month we try and update this database with for bn104 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bn104

Every month we try and update this database with for bn104 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bn104 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.