RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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

Quick Facts

Study Start:2023-07-20
Study Completion:2025-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05756322

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female subjects greater than 18 years old, inclusive.
  2. * Pathologically confirmed diagnoses of Relapsed or resistant AML or ALL.
  3. * 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.
  4. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
  1. * Concomitant chemotherapy, radiation therapy, or immunotherapy.
  2. * Receiving any other investigational agents concurrently or within 30 days prior to screening.
  3. * Patient has acute promyelocytic leukaemia or leukemia with active CNS involvement.
  4. * History of another active malignancy with 2 years prior to study entry, basal cell skin cancer and previous carcinoma in treated curatively.
  5. * Patient with mental deficits and/or psychiatric history

Contacts and Locations

Study Contact

Lin BioScience Clinical Operations
CONTACT
+886975781753
clinicaltrial@linbioscience.com

Study Locations (Sites)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Lin BioScience, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-20
Study Completion Date2025-12-15

Study Record Updates

Study Start Date2023-07-20
Study Completion Date2025-12-15

Terms related to this study

Keywords Provided by Researchers

  • CDC7 inhibitor
  • LBS-007
  • AML
  • ALL

Additional Relevant MeSH Terms

  • Relapsed or Resistant Acute Leukaemias