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

Last updated: October 8, 2024
Sponsor: Lin BioScience, Inc
Overall Status: Active - Recruiting

Phase

1/2

Condition

Leukemia

Treatment

LBS-007

Clinical Study ID

NCT05756322
LBS-007-CT01
  • Ages 18-120
  • All Genders

Study 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

Inclusion

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 indurable remission or cure, or who have no known therapy options of documentedbenefit.

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

Exclusion

Exclusion Criteria:

  • Concomitant chemotherapy, radiation therapy, or immunotherapy.

  • Receiving any other investigational agents concurrently or within 30 days prior toscreening.

  • Patient has acute promyelocytic leukaemia or leukemia with active CNS involvement.

  • History of another active malignancy with 2 years prior to study entry, basal cellskin cancer and previous carcinoma in treated curatively.

  • Patient with mental deficits and/or psychiatric history

Study Design

Total Participants: 90
Treatment Group(s): 1
Primary Treatment: LBS-007
Phase: 1/2
Study Start date:
July 20, 2023
Estimated Completion Date:
December 15, 2025

Connect with a study center

  • Wollongong Private Hospital

    Wollongong, New South Wales
    Australia

    Active - Recruiting

  • Pindara Private Hospital

    Benowa, Queensland
    Australia

    Active - Recruiting

  • The Royal Adelaide Hospital

    Adelaide, South Australia
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria
    Australia

    Active - Recruiting

  • Hollywood Private Hospital

    Nedlands, Western Australia
    Australia

    Site Not Available

  • China Medical University Hospital

    Taichung,
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan,
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland 21287
    United States

    Site Not Available

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