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

A Phase 1/2, Open-label, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias

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.

Inclusion Criteria:

• Male or female subjects greater than 18 years old, inclusive.
• Pathologically confirmed diagnoses of Relapsed or resistant 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 2 years prior to study entry, basal cell skin cancer and previous carcinoma in treated curatively.
• Patient with mental deficits and/or psychiatric history that precludes them from giving informed consent or from following protocol.