Relapsed or Resistant Acute LeukaemiasPhase 1/2NCT05756322
The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias
A Phase 1/2 study testing LBS-007 in people with Relapsed or Resistant Acute Leukaemias, run by Lin BioScience, Inc at 17 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Relapsed or Resistant Acute Leukaemias
- What is being tested?
- LBS-007
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 20 Jul 2023to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 4 countries
Australia6 sites, 1 recruiting
- Recruiting
The Royal Adelaide Hospital
Adelaide, South Australia
PI
- Completed
Pindara Private Hospital
Benowa, Queensland
- Active, not recruiting
The Alfred Hospital
Melbourne, Victoria
- Withdrawn
Hollywood Private Hospital
Nedlands, Washington
- Withdrawn
Q Medical Conselling
Perth, Washington, 6009
- Completed
Wollongong Private Hospital
Wollongong, New South Wales
United States5 sites, 5 recruiting
- Recruiting
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
PI
- Recruiting
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
PI
- Not yet recruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, 60611
PI
- Recruiting
The University of Kansas Hospital
Fairway, Kansas, 66205
PI
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
PI
China3 sites, 3 recruiting
- Recruiting
Jining No.1 People's Hospital
Jining, Shandong, 272011
PI
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, 300020
PI
- Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100
PI
Taiwan3 sites, 3 recruiting
- Not yet recruiting
China Medical University Hospital
Taichung
PI
- Not yet recruiting
National Cheng Kung University Hospital
Tainan
PI
- Not yet recruiting
National Taiwan University Hospital
Taipei
PI
About this study
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
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.
- Conditions
- Relapsed or Resistant Acute Leukaemias
- Being tested
- LBS-007
- Keywords
- CDC7 inhibitor, LBS-007, AML, ALL
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBS-007Drug
Open Label.
| Study group | Role | What they receive |
|---|---|---|
| Dose Finding and Expansion Phase | Experimental | 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) Receives: Drug: LBS-007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number, severity and duration of adverse events (AEs) and treatment-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.
Measured: 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.
Measured: From baseline through 28 days after end of last treatment cycle (up to 12 months)
Secondary outcomes (4)
Maximum Plasma Concentration (Cmax) of LBS-007 in plasma.
Measured: 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.
Measured: 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.
Measured: 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.
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
Measured: From baseline through 28 days after end of last treatment cycle (up to 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start20 Jul 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Resistant Acute LeukaemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lin BioScience, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lin BioScience Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756322
- Sponsor's protocol ID
- LBS-007-CT01
- Status last verified
- Aug 2025
- First submitted
- 20 Oct 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05756322
- Acronym / sponsor ID
- LBS-007-CT01
- Conditions
- Relapsed or Resistant Acute Leukaemias
- Keywords
- CDC7 inhibitor, LBS-007, AML, ALL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Lin BioScience, IncIndustry (pharma, biotech, devices)
- Collaborators
- Lin BioScience Pty Ltd
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Finding and Expansion Phase | Experimental | Drug: LBS-007Phase 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) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LBS-007Open Label. | Drug | Dose Finding and Expansion Phase |
Primary outcome
Number, severity and duration of adverse events (AEs) and treatment-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.
Time frame: 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.
Time frame: From baseline through 28 days after end of last treatment cycle (up to 12 months)
4 secondary outcomes
Maximum Plasma Concentration (Cmax) of LBS-007 in plasma.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline through 28 days after end of last treatment cycle (up to 12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LBS-007 in people with Relapsed or Resistant Acute Leukaemias, run by Lin BioScience, Inc at 17 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Australia, United States, China, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin BioScience Clinical Operations (+886975781753, clinicaltrial@linbioscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number, severity and duration of adverse events (AEs) and treatment-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5. (time frame: From baseline through 28 days after end of last treatment cycle (up to 12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.