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| Name | Class |
|---|---|
| Lin BioScience Pty Ltd | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Finding and Expansion Phase | Experimental | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBS-007 | Drug | Open Label. |
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| 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) | |
| Recommended Phase 2 Dose (RP2D) of LBS-007 in the subject population. | From baseline through 28 days after end of last treatment cycle (up to 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin BioScience Clinical Operations | Contact | +886975781753 | clinicaltrial@linbioscience.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Recruiting | Tampa | Florida | 33612 | United States |
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| 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. | Objective response rate (ORR): Defined for AML as complete response (CR), CR with partial hematological recovery (CRh), CR with incomplete hematological recovery (CRi), morphologic leukemia free state (MLFS), or partial response (PR) as assessed by bone marrow and peripheral blood Defined for ALL as CR, CRh, CRi, or MLFS | From baseline through 28 days after end of last treatment cycle (up to 12 months) |
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Not yet recruiting | Chicago | Illinois | 60611 | United States |
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| The University of Kansas Hospital | Recruiting | Fairway | Kansas | 66205 | United States |
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| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | Baltimore | Maryland | 21287 | United States |
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| UNC Hospitals, The University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
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| Wollongong Private Hospital | Completed | Wollongong | New South Wales | Australia |
| Pindara Private Hospital | Completed | Benowa | Queensland | Australia |
| The Royal Adelaide Hospital | Recruiting | Adelaide | South Australia | Australia |
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| The Alfred Hospital | Active, not recruiting | Melbourne | Victoria | Australia |
| Hollywood Private Hospital | Withdrawn | Nedlands | Washington | Australia |
| Q Medical Conselling | Withdrawn | Perth | Washington | 6009 | Australia |
| The First Affiliated Hospital of Xinxiang Medical University | Recruiting | Xinxiang | Henan | 453100 | China |
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| Jining No.1 People's Hospital | Recruiting | Jining | Shandong | 272011 | China |
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| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | Recruiting | Tianjin | 300020 | China |
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| China Medical University Hospital | Not yet recruiting | Taichung | Taiwan |
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| National Cheng Kung University Hospital | Not yet recruiting | Tainan | Taiwan |
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| National Taiwan University Hospital | Not yet recruiting | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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