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NCT Number: NCT05756322

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.

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Key information

Conditions

Relapsed or Resistant Acute Leukaemias Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Wollongong Private Hospital, Wollongong, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LBS-007

Drug

Open Label.

Primary outcomes

  1. Number, severity and duration of adverse events (AEs) and treatment-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.

    Time frame: From baseline through 28 days after end of last treatment cycle (up to 12 months)

  2. Recommended Phase 2 Dose (RP2D) of LBS-007 in the subject population.

    Time frame: From baseline through 28 days after end of last treatment cycle (up to 12 months)

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax) of LBS-007 in plasma.

    Time frame: Immediately before treatment initiation on Day 1, 3, and 5, or before treatment completion (Day 8), - Then 0.5 (±5 minutes), 1, 2, 4, 6, 10, and 24 (±15 minutes) hours after treatment initiation (Day 1) or completion (Day 8) of first treatment cycle.

  2. Time to Maximum Plasma Concentration (Tmax) of LBS-007 in plasma.

    Time frame: Immediately before treatment initiation on Day 1, 3, and 5, or before treatment completion (Day 8), - Then 0.5 (±5 minutes), 1, 2, 4, 6, 10, and 24 (±15 minutes) hours after treatment initiation (Day 1) or completion (Day 8) of first treatment cycle.

  3. Area under the drug concentration-time curve (AUC) of LBS-007 in plasma.

    Time frame: Immediately before treatment initiation on Day 1, 3, and 5, or before treatment completion (Day 8), - Then 0.5 (±5 minutes), 1, 2, 4, 6, 10, and 24 (±15 minutes) hours after treatment initiation (Day 1) or completion (Day 8) of first treatment cycle.

  4. Efficacy of LBS-007 assessed by bone marrow and peripheral blood.

    Time frame: From baseline through 28 days after end of last treatment cycle (up to 12 months)

    Objective response rate (ORR): Defined for AML as complete response (CR), CR with partial hematological recovery (CRh), CR with incomplete hematological recovery (CRi), morphologic leukemia free state (MLFS), or partial response (PR) as assessed by bone marrow and peripheral blood Defined for ALL as CR, CRh, CRi, or MLFS

Study contacts

Contact information is provided by the study sponsor or research team.

Lin BioScience Clinical Operations

CONTACT

[email protected]

+886975781753

Sponsors and collaborators

Lead sponsor

Lin BioScience, Inc

Industry

Collaborators

  • Lin BioScience Pty Ltd

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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