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
- Phase
- Phase 1
- Intervention
- LBS-007
- Conditions
- Relapsed or Resistant Acute Leukaemias
- Sponsor
- Lin BioScience, Inc
- Enrollment
- 90
- Locations
- 14
- Primary Endpoint
- Number, severity and duration of adverse events (AEs) and treatment-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
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.
Arms & Interventions
Dose Finding and Expansion Phase
Phase 1: Dose finding phase to evaluate LBS-007 as a monotherapy and combination with Venetoclax and Azacitidine Phase 2: Dose expansion phase to evaluate LBS-007 as a monotherapy and combination therapy at the optimal dose identified by phase 1 (dose finding)
Intervention: LBS-007
Outcomes
Primary Outcomes
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 Outcomes
- Maximum Plasma Concentration (Cmax) of LBS-007 in plasma.(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.(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.(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.(From baseline through 28 days after end of last treatment cycle (up to 12 months))