Overview

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

Status:
Not yet recruiting
Trial end date:
2025-12-15
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Lin BioScience, Inc
Collaborator:
Lin BioScience Pty Ltd
Criteria
Inclusion Criteria:

- Male or female subjects greater than 18 years old, inclusive.

- Pathologically confirmed diagnoses of Relapsed or resistant MDS/AML or ALL.

- Patients who are ineligible for standard therapies that are anticipated to result in
durable remission or cure, or who have no known therapy options of documented benefit.

- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

Exclusion Criteria:

- Concomitant chemotherapy, radiation therapy, or immunotherapy.

- Receiving any other investigational agents concurrently or within 30 days prior to
screening.

- Patient has Acute Promyelocytic Leukaemia or leukemia with active CNS involvement.

- History of another active malignancy with 5 years prior to study entry, basal cell
skin cancer and previous carcinoma in treated curatively.

- Patient with mental deficits and/or psychiatric history