NCT05756322PHASE1, PHASE2Recruiting

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

Lin BioScience, Inc

Start Date

7/20/2023

Completion Date

12/31/2026

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 Criteria

Age Range: 18 years to 120 years

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.

Interventions

DRUG

LBS-007

National Taiwan University Hospital

Taipei,

Taiwan