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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Relapsed or Resistant Acute Leukaemias

Intervention / Treatment
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* Drug: LBS-007


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CDC7 inhibitor