The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias
NCT05756322 · Phase 1, Phase 2 · Tampa, Florida, United States
- Condition
- Leukemia
- Disease stage
- Stage I-IV
- Phase
- Phase 1, Phase 2
- Study type
- DRUG
- Intervention
- LBS-007
- Age
- 18 Years to 120 Years
- Gender
- All
- Sponsor
- Lin BioScience, Inc
- Research institution
- Lin BioScience, Inc
- Facility
- Moffitt Cancer Center
- Research center
- Moffitt Cancer Center
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.
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.
Primary outcomes
Number, severity and duration of adverse events (AEs) and treatment-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.; Recommended Phase 2 Dose (RP2D) of LBS-007 in the subject population.
Secondary outcomes
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.