The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias
Purpose
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.
Condition
- Relapsed or Resistant Acute Leukaemias
Eligibility
- Eligible Ages
- Between 18 Years and 120 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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) |
|
Recruiting Locations
Fairway 4271358, Kansas 4273857 66205
PI
More Details
- Status
- Recruiting
- Sponsor
- Lin BioScience, Inc