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

NCT05690425 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2023-07-24

No results posted yet for this study

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.

Conditions

  • Hematologic Malignancy

Interventions

DRUG

BC3402 Injection

Subjects will receive BC3402 as a single agent via intravenous infusion once every 3-weeks (Q3W),the dose of BC3402 was calculated according to the dose group and body weight of the subjects.

Sponsors & Collaborators

  • Biocity Biopharmaceutics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • hui zeng, prof · First Affiliated Hospital of Jinan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-06
Primary Completion
2024-03-15
Completion
2024-06-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05690425 on ClinicalTrials.gov