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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 willing to sign a consent form or from following protocol. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

LBS-007

Open Label.

Locations (17)

Moffitt Cancer Center
Tampa, Florida, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
The University of Kansas Hospital
Fairway, Kansas, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Wollongong Private Hospital
Wollongong, New South Wales, Australia
Pindara Private Hospital
Benowa, Queensland, Australia
The Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Hollywood Private Hospital
Nedlands, Washington, Australia
Q Medical Conselling
Perth, Washington, Australia
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Jining No.1 People's Hospital
Jining, Shandong, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, China
China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan