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.

Study Overview

• Status: Recruiting
• Conditions: Relapsed or Resistant Acute Leukaemias
• Intervention / Treatment: Drug: LBS-007

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Lin BioScience Clinical Operations; Phone Number: +886975781753; Email: clinicaltrial@linbioscience.com

Study Locations

• Australia
  • New South Wales
    • Wollongong, New South Wales, Australia
      • Completed
      • Wollongong Private Hospital
  • Queensland
    • Benowa, Queensland, Australia
      • Completed
      • Pindara Private Hospital
  • South Australia
    • Adelaide, South Australia, Australia
      • Recruiting
      • The Royal Adelaide Hospital
      • Contact: PI
  • Victoria
    • Melbourne, Victoria, Australia
      • Active, not recruiting
      • The Alfred Hospital
  • Washington
    • Nedlands, Washington, Australia
      • Withdrawn
      • Hollywood Private Hospital
    • Perth, Washington, Australia, 6009
      • Withdrawn
      • Q Medical Conselling
• China
  • Tianjin, China, 300020
    • Recruiting
    • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
    • Contact: PI
  • Henan
    • Xinxiang, Henan, China, 453100
      • Recruiting
      • The First Affiliated Hospital of Xinxiang Medical University
      • Contact: PI
  • Shandong
    • Jining, Shandong, China, 272011
      • Recruiting
      • Jining No.1 people's hospital
      • Contact: PI
• Taiwan
  • Taichung, Taiwan
    • Not yet recruiting
    • China Medical University Hospital
    • Contact: PI
  • Tainan, Taiwan
    • Not yet recruiting
    • National Cheng Kung University Hospital
    • Contact: PI
  • Taipei, Taiwan
    • Not yet recruiting
    • National Taiwan University Hospital
    • Contact: PI
• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Contact: PI
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Not yet recruiting
      • Robert H. Lurie Comprehensive Cancer Center of Northwestern University
      • Contact: PI
  • Kansas
    • Fairway, Kansas, United States, 66205
      • Recruiting
      • The University of Kansas Hospital
      • Contact: PI
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
      • Contact: PI
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • UNC Hospitals, The University of North Carolina at Chapel Hill
      • Contact: PI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Finding and Expansion Phase; Phase 1: Dose finding phase to evaluate LBS-007 as a monotherapy and combination with Venetoclax and Azacitidine Phase 2: Dose expansion phase to evaluate LBS-007 as a monotherapy and combination therapy at the optimal dose identified by phase 1 (dose finding)	Drug: LBS-007; Open Label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number, severity and duration of adverse events (AEs) and treatment-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.	From baseline through 28 days after end of last treatment cycle (up to 12 months)
Recommended Phase 2 Dose (RP2D) of LBS-007 in the subject population.	From baseline through 28 days after end of last treatment cycle (up to 12 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration (Cmax) of LBS-007 in plasma.		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.
Time to Maximum Plasma Concentration (Tmax) of LBS-007 in plasma.		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.
Area under the drug concentration-time curve (AUC) of LBS-007 in plasma.		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.
Efficacy of LBS-007 assessed by bone marrow and peripheral blood.	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	From baseline through 28 days after end of last treatment cycle (up to 12 months)

Collaborators and Investigators

• Sponsor: Lin BioScience, Inc
• Collaborators: Lin BioScience Pty Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: AML; ALL; CDC7 inhibitor; LBS-007
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Recurrence
• Other Study ID Numbers: LBS-007-CT01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No