drugset / Trial / NCT05756322

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

NCT05756322 ↗

Phase 1/2 Recruiting 90 enrolled Lin BioScience, Inc Lin BioScience Pty Ltd · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-07-20
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject GRANATICIN B Small molecule — —

Indications