The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LBS-007.
- Who it may be relevant to
- Registry conditions: Relapsed or Resistant Acute Leukaemias. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, China, Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug LBS-007
Open Label.
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. [Time frame: 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. [Time frame: From baseline through 28 days after end of last treatment cycle (up to 12 months)]
Secondary outcome measures (4)
- Maximum Plasma Concentration (Cmax) of LBS-007 in plasma. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: From baseline through 28 days after end of last treatment cycle (up to 12 months)]
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 that precludes them from giving informed consent or from following protocol.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 6 centers
- Wollongong Private Hospital — Wollongong
- Pindara Private Hospital — Benowa
- The Royal Adelaide Hospital — Adelaide
- The Alfred Hospital — Melbourne
- Hollywood Private Hospital — Nedlands
- Q Medical Conselling — Perth
United States · 5 centers
- Moffitt Cancer Center — Tampa
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago
- The University of Kansas Hospital — Fairway
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore
- UNC Hospitals, The University of North Carolina at Chapel Hill — Chapel Hill
China · 3 centers
- The First Affiliated Hospital of Xinxiang Medical University — Xinxiang
- Jining No.1 People's Hospital — Jining
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin
Taiwan · 3 centers
- China Medical University Hospital — Taichung
- National Cheng Kung University Hospital — Tainan
- National Taiwan University Hospital — Taipei
Identifiers
NCT: NCT05756322 · LBS-007-CT01