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Trial Title:
The Safety and Tolerability of LBS-007 in Patients with Relapsed or Resistant Acute Leukaemias
NCT ID:
NCT05756322
Condition:
Relapsed or Resistant Acute Leukaemias
Conditions: Official terms:
Leukemia
Acute Disease
Conditions: Keywords:
CDC7 inhibitor
LBS-007
AML
ALL
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
LBS-007
Description:
Open Label.
Arm group label:
Dose Finding and Expansion Phase
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
120 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
PI
Facility:
Name:
Wollongong Private Hospital
Address:
City:
Wollongong
Country:
Australia
Status:
Recruiting
Contact:
Last name:
PI
Facility:
Name:
Pindara Private Hospital
Address:
City:
Benowa
Country:
Australia
Status:
Recruiting
Contact:
Last name:
PI
Facility:
Name:
The Royal Adelaide Hospital
Address:
City:
Adelaide
Country:
Australia
Status:
Recruiting
Contact:
Last name:
PI
Facility:
Name:
The Alfred Hospital
Address:
City:
Melbourne
Country:
Australia
Status:
Recruiting
Contact:
Last name:
PI
Facility:
Name:
Hollywood Private Hospital
Address:
City:
Nedlands
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
PI
Facility:
Name:
China Medical University Hospital
Address:
City:
Taichung
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
PI
Facility:
Name:
National Cheng Kung University Hospital
Address:
City:
Tainan
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
PI
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Country:
Taiwan
Status:
Not yet recruiting
Contact:
Last name:
PI
Start date:
July 20, 2023
Completion date:
December 15, 2025
Lead sponsor:
Agency:
Lin BioScience, Inc
Agency class:
Industry
Collaborator:
Agency:
Lin BioScience Pty Ltd
Agency class:
Other
Source:
Lin BioScience, Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05756322
