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A Phase I, Open-Label, Dose Escalation and Cohort Expansion Study of BS HH 002.SA in Patients With AML and MDS

NCT04743115 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2021-02-08

No results posted yet for this study

Summary

Indication:Relapsed or refractory AML in patients for whom no established treatment options are available (this indication will heretofore be referred to as the protocol AML indication), or adult patients with MDS who are classified as high risk or very high risk according to the Revised International Prognosis Scoring System (IPSS-R).

Number of Investigators and Study Centers:Up to 5 Investigators in the US. Objectives:Dose Escalation Part

Primary Objective:

1. To determine the maximum tolerated dose (MTD) of BS HH 002.SA administered subcutaneously once per day for 12 days of a 28-day cycle.

Secondary Objectives:
2. To provide an initial safety profile of single and multiple cycles of BS HH 002.SA.
3. To assess the pharmacokinetic (PK) profile of BS HH 002.SA.
4. To explore the anti-tumor activity of BS HH 002.SA in patients with the protocol AML indication or high-risk MDS.
5. To explore cytogenetics of the malignant cells in relation to response to BS HH 002.SA.

Cohort Expansion Part

Primary Objectives:

1. To evaluate safety and tolerability of BS HH 002.SA at MTD and/or lower dose level (DL) in selected cohorts of patients with the protocol AML indication or high-risk MDS.
2. To evaluate preliminary anti-tumor activity of BS HH 002.SA at MTD and/or lower DL in selected cohorts of patients with the protocol AML indication or high-risk MDS.

Secondary Objectives:
3. To assess the PK profile of BS HH 002.SA.
4. To explore cytogenetics of the malignant cells in relation to response to BS HH 002.SA.

Study Population:Adult patients with the protocol AML indication or high-risk MDS.

Conditions

  • Acute Myeloid Leukemia, Myelodysplastic Syndrome

Interventions

DRUG

BS HH 002.SA

The Dose Escalation Part is a 3+3 design dose escalation study to determine the MTD of BS HH 002.SA in up to approximately 30 patients with the protocol AML indication or high risk MDS. Cohorts of 3 patients will be sequentially assigned to receive BS HH 002.SA at escalating DLs following the standard 3+3 dose escalation design, with 3 to 6 patients at each DL. Cohort Expansion Part: Following determination of the MTD, the study will continue at the MTD and/or a lower DL

Sponsors & Collaborators

  • Shanghai Bensen Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-28
Primary Completion
2025-02-28
Completion
2025-02-28
FDA Drug
Yes

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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 NCT04743115 on ClinicalTrials.gov