Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06052813 | A Study of BN104 in the Treatment of Acute Leukemia | PHASE1 | ACTIVE NOT_RECRUITING | 66 | — | — | Oct 19, 2023 | Dec 1, 2027 | Feb 25, 2026 | 1 | China |
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 evaluate the efficacy of BN104 in treating patients with relapsed/refractory acute leukaemia with specific mutations (KMT2A rearrangement or NPM1 mutation) by mesuring patients bone marrow blasts/immature cells(CR, CRh rate) at protocol defined efficacy assessment timepoint
| Arm | Type | Description |
|---|---|---|
| 200mg QD | EXPERIMENTAL | 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. |
| 200mg BID | EXPERIMENTAL | 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. |
| 400mg BID | EXPERIMENTAL | 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. |
| 600 BID | EXPERIMENTAL | 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. |
| 800 BID | EXPERIMENTAL | 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. |
| Adolescent cohort - 400mg BID | EXPERIMENTAL | The first 3-6 patients will be dosed at 400 mg BID. If there is no significant difference in Cmax and AUC between adolescent and adult patients, and no DLT occurs in 3-6 patients or ≤1 DLT occurs in 6 patients, the dose will be escalated to 600 mg BID, and 3-6 additional adolescent patients will be enrolled. 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. |
| Adolescent cohort - 600mg BID | EXPERIMENTAL | 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. If ≤1 DLT occurs in 6 patients, at 600mg bid, then enrolment will be expanded at the 600 mg BID dose level to approximately 20 patients, for patients with relapsed/refractory acute leukaemia with KMT2A rearrangement and NPM1 mutation, ensuring at least 10 patients each with KMT2A rearrangement and NPM1 mutation in relapsed/refractory acute leukaemia at the 600 mg BID dose level. |
| Phase II CohortA - Patients with relapsed/refractory AML with NPM1 mutation | EXPERIMENTAL | receiving oral BN104 treatment at a dose of 600 mg BID (300 mg BID when co-administered with strong CYP3A4 inhibitors) |
| Phase II Cohort B: r/r acute leukaemia with KMT2Ar (including AML, ALL, or MPL) | EXPERIMENTAL | receiving oral BN104 treatment at a dose of 600 mg BID (300 mg BID when co-administered with strong CYP3A4 inhibitors) |
| Name | Type | Description |
|---|---|---|
| BN104 monotherapy | DRUG | Phase I(adults): 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 monotherapy - rp2d | DRUG | receiving oral BN104 treatment at a dose of 600 mg BID (300 mg BID when co-administered with strong CYP3A4 inhibitors) |
Inclusion Criteria: 1. Have been fully informed about the study and have voluntarily signed the ICF; 2. Patients diagnosed with relapsed/refractory acute leukaemia (including AML, ALL, and mixed-phenotype acute leukaemia, excluding acute promyelocytic leukaemia) according to the World Health Organi...