Clinical Trials List
Protocol NumberLBS-007-CT01
NCT Number(ClinicalTrials.gov Identfier)NCT05756322
Not yet recruiting
2023-03-01 - 2026-12-31
Phase I/II
Recruiting3
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
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Trial Applicant
Lin BioScience, Inc.
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Wen-Chien Chou Division of Others -
- Tai-Chung Huang Division of General Internal Medicine
- Shang-Ju Wu Division of General Internal Medicine
- MING YAO Division of General Internal Medicine
- Chieh-Lung Cheng Division of General Internal Medicine
- SHAN-CHI YU Division of Others -
- Chien-Chin Lin Division of Others -
- Huai-Hsuan Huang Division of General Internal Medicine
- 田豐銘 Division of General Internal Medicine
- HSIN-AN HOU Division of General Internal Medicine
- CHENG-HONG TSAI Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Che-Hung Lin Division of Hematology & Oncology
- 陳珈妤 Division of Hematology & Oncology
- Ming-Yu Lien Division of Hematology & Oncology
- 鄭富銘 Division of Hematology & Oncology
- Tzu-Ting Chen Division of Hematology & Oncology
- 王幸婷 Division of Hematology & Oncology
- Ching-Chan Lin Division of Hematology & Oncology
- Chi-Ching Chen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ya-Ping Chen Division of Hematology & Oncology
- Ya-Ting Hsu Division of Hematology & Oncology
- Sin-Syue Li Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Relapsed or Resistant Acute Leukaemias
Objectives
main:
‧ Evaluate the safety and tolerability of LBS-007 in subject groups
‧ Confirm the maximum tolerated dose (MTD) of LBS-007 in the subject population
secondary:
‧ Confirm the pharmacokinetic (PK) profile of LBS-007 in subject groups
‧ Evaluate the efficacy of LBS-007 in subject groups
Exploratory purpose:
‧ Study changes in surrogate biomarkers in response to treatment and their correlation with identifying TP53 mutations.
Test Drug
LBS-007
Active Ingredient
LBS-007
Dosage Form
IV injection
Dosage
0.5mg/ml
Endpoints
The incidence, severity, and duration of adverse events (AEs) and treatment-related AEs were evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5 (v5) classification.
Maximum tolerated dose of LBS-007.
Maximum tolerated dose of LBS-007.
Inclution Criteria
Inclusion Criteria:
Male or female subjects greater than 18 years old, inclusive.
Pathologically confirmed diagnoses of Relapsed or resistant MDS/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.
Male or female subjects greater than 18 years old, inclusive.
Pathologically confirmed diagnoses of Relapsed or resistant MDS/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
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 5 years prior to study entry, basal cell skin cancer and previous carcinoma in treated curatively.
Patient with mental deficits and/or psychiatric history
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 5 years prior to study entry, basal cell skin cancer and previous carcinoma in treated curatively.
Patient with mental deficits and/or psychiatric history
The Estimated Number of Participants
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Taiwan
30 participants
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Global
90 participants
