A Phase I Study of BC3402 as a Single Agent in Patients With MDS and CMML
Status:
Not yet recruiting
Trial end date:
2024-06-15
Target enrollment:
Participant gender:
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.