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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05756322




Registration number
NCT05756322
Ethics application status
Date submitted
20/10/2022
Date registered
6/03/2023
Date last updated
25/04/2024

Titles & IDs
Public title
The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias
Scientific 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
Secondary ID [1] 0 0
LBS-007-CT01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsed or Resistant Acute Leukaemias 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LBS-007

Experimental: Dose Finding and Expansion Phase - Phase 1: Dose finding Phase 2: Optimal dose identified by phase 1 (dose finding) administrated to subject.


Treatment: Drugs: LBS-007
Open Label.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number, severity and duration of adverse events (AEs) and treatment-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.
Timepoint [1] 0 0
From baseline through 28 days after end of last treatment cycle (up to 12 months)
Primary outcome [2] 0 0
Maximum Tolerated Dose (MTD) of LBS-007 in the subject population.
Timepoint [2] 0 0
From baseline through 28 days after end of last treatment cycle (up to 12 months)
Secondary outcome [1] 0 0
Maximum Plasma Concentration (Cmax) of LBS-007 in plasma.
Timepoint [1] 0 0
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.
Secondary outcome [2] 0 0
Time to Maximum Plasma Concentration (Tmax) of LBS-007 in plasma.
Timepoint [2] 0 0
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.
Secondary outcome [3] 0 0
Area under the drug concentration-time curve (AUC) of LBS-007 in plasma.
Timepoint [3] 0 0
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.
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
From baseline through 28 days after end of last treatment cycle (up to 12 months)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
120 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/12/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Wollongong Private Hospital - Wollongong
Recruitment hospital [2] 0 0
Pindara Private Hospital - Benowa
Recruitment hospital [3] 0 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
Hollywood Private Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
- Wollongong
Recruitment postcode(s) [2] 0 0
- Benowa
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Melbourne
Recruitment postcode(s) [5] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
Taiwan
State/province [1] 0 0
Taichung
Country [2] 0 0
Taiwan
State/province [2] 0 0
Tainan
Country [3] 0 0
Taiwan
State/province [3] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Lin BioScience, Inc
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Lin BioScience Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05756322
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lin BioScience Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
+886975781753
Fax 0 0
Email 0 0
clinicaltrial@linbioscience.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05756322