RecruitingRecruiting
The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias
NCT05756322 · Lin BioScience, Inc
In plain English
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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
About this study
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 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:
* 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
Enrollment target: 90 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-07-20
Estimated completion: 2026-12-31
Last updated: 2026-03-27
Interventions
Drug: LBS-007
Primary outcomes
- • Number, severity and duration of adverse events (AEs) and treatment-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5. (From baseline through 28 days after end of last treatment cycle (up to 12 months))
- • Recommended Phase 2 Dose (RP2D) of LBS-007 in the subject population. (From baseline through 28 days after end of last treatment cycle (up to 12 months))
Sponsor
Lin BioScience, Inc · industry
With: Lin BioScience Pty Ltd
Contacts & investigators
ContactLin BioScience Clinical Operations · contact · clinicaltrial@linbioscience.com · +886975781753
All locations (17)
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityNot Yet Recruiting
Chicago, Illinois, United States
The University of Kansas HospitalRecruiting
Fairway, Kansas, United States
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsRecruiting
Baltimore, Maryland, United States
UNC Hospitals, The University of North Carolina at Chapel HillRecruiting
Chapel Hill, North Carolina, United States
Wollongong Private HospitalCompleted
Wollongong, New South Wales, Australia
Pindara Private HospitalCompleted
Benowa, Queensland, Australia
The Royal Adelaide HospitalRecruiting
Adelaide, South Australia, Australia
The Alfred HospitalActive Not Recruiting
Melbourne, Victoria, Australia
Hollywood Private HospitalWithdrawn
Nedlands, Washington, Australia
Q Medical ConsellingWithdrawn
Perth, Washington, Australia
The First Affiliated Hospital of Xinxiang Medical UniversityRecruiting
Xinxiang, Henan, China
Jining No.1 People's HospitalRecruiting
Jining, Shandong, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical SciencesRecruiting
Tianjin, China
China Medical University HospitalNot Yet Recruiting
Taichung, Taiwan
National Cheng Kung University HospitalNot Yet Recruiting
Tainan, Taiwan
National Taiwan University HospitalNot Yet Recruiting
Taipei, Taiwan