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

Phase 1

Recruiting

• Conditions: Relapsed or Resistant Acute Leukaemias
• Interventions: Drug: LBS-007

• Registration Number: NCT05756322
• Lead Sponsor: Lin BioScience, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-20
• Study First Submitted QC: 2023-02-23
• Study First Posted: 2023-03-06
• Study Start: 2023-07-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-11
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose Finding and Expansion Phase	LBS-007	Phase 1: Dose finding phase to evaluate LBS-007 as a monotherapy and combination with Venetoclax and Azacitidine Phase 2: Dose expansion phase to evaluate LBS-007 as a monotherapy and combination therapy at the optimal dose identified by phase 1 (dose finding)

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Maximum Plasma Concentration (Cmax) of LBS-007 in plasma.	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.
Time to Maximum Plasma Concentration (Tmax) of LBS-007 in plasma.	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.
Area under the drug concentration-time curve (AUC) of LBS-007 in plasma.	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.
Efficacy of LBS-007 assessed by bone marrow and peripheral blood.	From baseline through 28 days after end of last treatment cycle (up to 12 months)	Objective response rate (ORR): Defined for AML as complete response (CR), CR with partial hematological recovery (CRh), CR with incomplete hematological recovery (CRi), morphologic leukemia free state (MLFS), or partial response (PR) as assessed by bone marrow and peripheral blood Defined for ALL as CR, CRh, CRi, or MLFS

Trial Locations

Locations (9)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, 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, Western Australia, Australia

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan