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

Sponsor: Lin BioScience, Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05756322

Patient View

This clinical trial evaluates the safety, tolerability, and maximum tolerated dose of LBS-007 in adults with relapsed or resistant AML or ALL. Eligible participants are those over 18, with confirmed diagnoses, and limited treatment options. The study is open-label, focusing on efficacy, pharmacokinetics, and biomarker changes. Participants must have an ECOG status of 0 to 2.

Patient Parameters

Program Overview

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

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

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