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

• Status: Not yet recruiting
• Trial end date: 2025-02-01

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.

• Phase: Phase 1

Details

• Lead Sponsor: Shanghai Bensen Pharmaceutical Co., Ltd.