Clinical Trial 23650

• Overview

  Study Title:

  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

  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.

  Objective:

  Primary Objectives: To evaluate the safety and tolerability of LBS-007 in the patient population. To determine the recommended Phase 2 dose (RP2D) of LBS-007. Secondary Objectives: To characterize the pharmacokinetic (PK) profile of LBS-007. To evaluate the preliminary efficacy of LBS-007 based on bone marrow and cell count response. To evaluate the preliminary clinical activities of LBS-007 in terms of time to events.

• Treatments

  Therapies:

  BCL-2 inhibitor; CDC7 inhibitor; DNA methyltransferase inhibitor

  Medications:

  Azacitidine (5-azacitidine); GDC-0199 (Venetoclax); LBS-007 (); Venetoclax ()

• Inclusion 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

  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.

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