A Phase I Study of BC3402 as a Single Agent in Patients With MDS and CMML

Hematologic Malignancy Clinical Trial

Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BC3402 as a Single Agent in Patients With Myelodysplastic Syndrome SYNDR(MDS) and Chronic Myelomonocytic Leukemia(CMML)

Status Recruiting

Clinical Trial Summary

This is a phase I study to evaluate the safety ,Tolerability, PK, PD, and preliminary efficacy of BC3402 Monotherapy in MDS or CMML, and explore the RP2D/MTD dose. The patients with very low,low,intermediate,or high,very high risk of MDS or CMML,who meet the criteria will receive BC3402 as a single agent via intravenous infusion Q3W , Up to 3 dose cohorts will be sequentially enrolled using an accelerated titration combined with a "3+3 design" approach.Dose limiting toxicities (DLT) will be assessed during the first cycles (i.e., total 3 weeks). A Safety Monitoring Committee (SMC), comprised of the Sponsor's medical representatives, safety physician, and the principal investigator (PI), will be established for the determination of dose levels to be administered and dose regimen during dose escalation based on the data available from the previous dose levels. Additional dose levels may be explored based on the emerging safety, PK, and PD data during the study.

Clinical Trial Description

This is a phase I study to evaluate the safety ,Tolerability, PK, PD, and preliminary efficacy of BC3402 Monotherapy in MDS or CMML, and explore the RP2D/MTD dose. The patients with very low,low,intermediate,or high,very high risk of MDS or CMML,who meet the criteria will receive BC3402 as a single agent via intravenous infusion Q3W , Up to 3 dose cohorts will be sequentially enrolled using an accelerated titration combined with a "3+3 design" approach.Dose limiting toxicities (DLT) will be assessed during the first cycles (i.e., total 3 weeks). The Cohort1 will be enrolled 1 patient initially.If this subject experience any Grade 2 or higher toxicity during the first cycle, unless definitely unrelated to BC3402,2 more patients will be accrued,and the standard "3+3" dose escalation algorithm will be followed thereafter , with each cohort enrolling 3 to 6 subjects. Cohorts 2 and 3 will follow the traditional 3+3 dose escalation design. Dose limiting toxicities will be assessed during the first cycle(i.e., total21 days). If ≥ 2 subjects experience a DLT at a given dose level, the MTD would have been exceeded, further dose escalation is not pursued, and the prior dose level is expanded to six patients; if there is no more than one patient who experiences a DLT among those six patients, that dose level is considered the MTD. A Safety Monitoring Committee (SMC), comprised of the Sponsor's medical representatives, safety physician, and the principal investigator (PI), will be established for the determination of dose levels to be administered and dose regimen during dose escalation based on the data available from the previous dose levels. Additional dose levels may be explored based on the emerging safety, PK, and PD data during the study. ;

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms

• NCT number: NCT05690425
• Study type: Interventional
• Source: Biocity Biopharmaceutics Co., Ltd.
• Contact: hui zeng, prof
• Phone: 18002201919
• Email: xyzengh@hotmail.com
• Status: Recruiting
• Phase: Phase 1
• Start date: July 6, 2023
• Completion date: June 15, 2024