The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias

Condition(s) studied

Investigational drug(s) / intervention(s)

LBS-007: Open Label.

Study summary

The most common types of acute leukaemia are acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML). AML is a heterogenous clonal disorder of haemopoietic progenitor cells and the most common and severe malignant leukemia in adults and is responsible for the highest mortality from leukemia. ALL is a neoplasm characterized by the growth of malignant lymphoblasts of the B or T lineage, leading to an inhibition of proliferation of the normal blood cell lineages.

The primary objectives of this study are investigating the safety, tolerability, and the MTD of LBS-007. The secondary objectives are to assess the efficacy and to determine the pharmacokinetics (PK) of LBS-007. The exploratory objective is to study and correlate the changes in surrogate biomarkers in response to treatment.

Eligibility

Primary outcome measure(s)

• Number, severity and duration of adverse events (AEs) and treatment-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5. — From baseline through 28 days after end of last treatment cycle (up to 12 months)
• Recommended Phase 2 Dose (RP2D) of LBS-007 in the subject population. — From baseline through 28 days after end of last treatment cycle (up to 12 months)

Trial sites (17)