RecruitingPhase 1Phase 2NCT05756322

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

Sponsor

Lin BioScience, Inc

Enrollment

90 participants

Start Date

Jul 20, 2023

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is testing LBS-007, a new drug, in people with relapsed or treatment-resistant acute leukemia (AML or ALL — aggressive blood cancers) who have run out of standard options, to determine if it is safe and shows any signs of fighting the cancer. **You may be eligible if...** - You are 18 or older - You have been diagnosed with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that has returned or stopped responding to treatment - You are not eligible for treatments that could lead to long-term remission or cure, or no such treatments are available to you - Your general health is good enough to participate (ECOG performance status 0–2) **You may NOT be eligible if...** - You are currently receiving chemotherapy, radiation, or immunotherapy - Your health status does not meet the minimum requirements - You have conditions that would interfere with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLBS-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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05756322