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

Primary Purpose

Relapsed or Resistant Acute Leukaemias

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LBS-007
Sponsored by
Lin BioScience, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsed or Resistant Acute Leukaemias focused on measuring CDC7 inhibitor

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female subjects greater than 18 years old, inclusive. Pathologically confirmed diagnoses of Relapsed or resistant MDS/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 5 years prior to study entry, basal cell skin cancer and previous carcinoma in treated curatively. Patient with mental deficits and/or psychiatric history

Sites / Locations

  • Wollongong Private HospitalRecruiting
  • The Royal Adelaide HospitalRecruiting
  • The Alfred HospitalRecruiting
  • National Cheng Kung University Hospital
  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose Finding and Expansion Phase

Arm Description

Phase 1: Dose finding Phase 2: Optimal dose identified by phase 1 (dose finding) administrated to subject.

Outcomes

Primary Outcome Measures

Number, severity and duration of adverse events (AEs) and treatment-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.
Maximum Tolerated Dose (MTD) of LBS-007 in the subject population.

Secondary Outcome Measures

Maximum Plasma Concentration (Cmax) of LBS-007 in plasma.
Time to Maximum Plasma Concentration (Tmax) of LBS-007 in plasma.
Area under the drug concentration-time curve (AUC) of LBS-007 in plasma.
Efficacy of LBS-007 assessed by blood count recover and the reduction of blast cells or minimal residual disease (MRD) in bone marrow and/or peripheral blood.

Full Information

First Posted
October 20, 2022
Last Updated
October 18, 2023
Sponsor
Lin BioScience, Inc
Collaborators
Lin BioScience Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05756322
Brief Title
The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
December 15, 2025 (Anticipated)
Study Completion Date
December 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lin BioScience, Inc
Collaborators
Lin BioScience Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Resistant Acute Leukaemias
Keywords
CDC7 inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Finding and Expansion Phase
Arm Type
Experimental
Arm Description
Phase 1: Dose finding Phase 2: Optimal dose identified by phase 1 (dose finding) administrated to subject.
Intervention Type
Drug
Intervention Name(s)
LBS-007
Intervention Description
Open Label.
Primary Outcome Measure Information:
Title
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)
Title
Maximum Tolerated Dose (MTD) 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 Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax) of LBS-007 in plasma.
Time Frame
Immediately before treatment initiation (Day 1) 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.
Title
Time to Maximum Plasma Concentration (Tmax) of LBS-007 in plasma.
Time Frame
Immediately before treatment initiation (Day 1) 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.
Title
Area under the drug concentration-time curve (AUC) of LBS-007 in plasma.
Time Frame
Immediately before treatment initiation (Day 1) 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.
Title
Efficacy of LBS-007 assessed by blood count recover and the reduction of blast cells or minimal residual disease (MRD) in bone marrow and/or peripheral blood.
Time Frame
From baseline through 28 days after end of last treatment cycle (up to 12 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects greater than 18 years old, inclusive. Pathologically confirmed diagnoses of Relapsed or resistant MDS/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 5 years prior to study entry, basal cell skin cancer and previous carcinoma in treated curatively. Patient with mental deficits and/or psychiatric history
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin BioScience Clinical Operations
Phone
+886975781753
Email
clinicaltrial@linbioscience.com
Facility Information:
Facility Name
Wollongong Private Hospital
City
Wollongong
State/Province
New South Wales
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
The Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI

12. IPD Sharing Statement

Plan to Share IPD
No

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

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