Clinical trial NCT05756322: The Safety and Tolerability of LBS-007 in Patients with Relapsed or Resistant Acute Leukaemias
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Relapsed or Resistant Acute Leukaemias
Keywords: CDC7 inhibitor
LBS-007
AML
ALL
Lead sponsor: Lin BioScience, Inc
Sponsor class: INDUSTRY
Collaborators: name: Lin BioScience Pty Ltd
First posted: 2023-03-06
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Number, severity and duration of adverse events (AEs) and treatment-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.
timeFrame: From baseline through 28 days after end of last treatment cycle (up to 12 months)
measure: Recommended Phase 2 Dose (RP2D) of LBS-007 in the subject population.
timeFrame: From baseline through 28 days after end of last treatment cycle (up to 12 months)
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) of LBS-007 in plasma.
timeFrame: Immediately before treatment initiation on Day 1, 3, and 5, or before treatment completion (Day 8), - Then 0.5 (±5 minutes), 1, 2, 4, 6, 10, and 24 (±15 minutes) hours after treatment initiation (Day 1) or completion (Day 8) of first treatment cycle.
measure: Time to Maximum Plasma Concentration (Tmax) of LBS-007 in plasma.
timeFrame: Immediately before treatment initiation on Day 1, 3, and 5, or before treatment completion (Day 8), - Then 0.5 (±5 minutes), 1, 2, 4, 6, 10, and 24 (±15 minutes) hours after treatment initiation (Day 1) or completion (Day 8) of first treatment cycle.
measure: Area under the drug concentration-time curve (AUC) of LBS-007 in plasma.
timeFrame: Immediately before treatment initiation on Day 1, 3, and 5, or before treatment completion (Day 8), - Then 0.5 (±5 minutes), 1, 2, 4, 6, 10, and 24 (±15 minutes) hours after treatment initiation (Day 1) or completion (Day 8) of first treatment cycle.
measure: Efficacy of LBS-007 assessed by bone marrow and peripheral blood.
timeFrame: From baseline through 28 days after end of last treatment cycle (up to 12 months)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Wollongong
country: Australia
facility: Wollongong Private Hospital
state: New South Wales
city: Benowa
country: Australia
facility: Pindara Private Hospital
state: Queensland
city: Adelaide
country: Australia
facility: The Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Hollywood Private Hospital
state: Western Australia
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: