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

Sponsor

Lin BioScience, Inc (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05756322

Collaborator

Lin BioScience Pty Ltd (Other)

Enrollment

Locations

Arm

33.1

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsed or Resistant Acute Leukaemias	Drug: LBS-007	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Mar 13, 2023

Anticipated Primary Completion Date :

Dec 15, 2025

Anticipated Study Completion Date :

Dec 15, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Finding and Expansion Phase Phase 1: Dose finding Phase 2: Optimal dose identified by phase 1 (dose finding) administrated to subject.	Drug: LBS-007 Open Label.

Arm

Intervention/Treatment

Experimental: Dose Finding and Expansion Phase

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

Drug: LBS-007

Open Label.

Outcome Measures

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. [From baseline through 28 days after end of last treatment cycle (up to 12 months)]
Maximum Tolerated Dose (MTD) 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

Maximum Plasma Concentration (Cmax) of LBS-007 in plasma. [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.]
Time to Maximum Plasma Concentration (Tmax) of LBS-007 in plasma. [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.]
Area under the drug concentration-time curve (AUC) of LBS-007 in plasma. [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.]
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. [From baseline through 28 days after end of last treatment cycle (up to 12 months)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	The Royal Adelaide Hospital	Adelaide	Australia
2	The Alfred Hospital	Melbourne	Australia
3	National Cheng Kung University Hospital	Tainan	Taiwan
4	National Taiwan University Hospital	Taipei	Taiwan

Sponsors and Collaborators

Lin BioScience, Inc
Lin BioScience Pty Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lin BioScience, Inc

ClinicalTrials.gov Identifier:

NCT05756322

Other Study ID Numbers:

LBS-007-CT01

First Posted:

Mar 6, 2023

Last Update Posted:

Mar 6, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Lin BioScience, Inc

CDC7 inhibitor

Additional relevant MeSH terms:

Leukemia

Acute Disease

Study Results

No Results Posted as of Mar 6, 2023