LBS-007 for Relapsed or Resistant Acute Leukaemias
The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias
Recruiting
Phase 1Phase 2Interventional Study
Relapsed or Resistant Acute Leukaemias
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 120
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
90 (estimated)
Sponsor
Lin BioScience, Inc · Industry
Who this trial is looking for
This trial is looking for adults with relapsed or resistant acute leukaemias who cannot receive standard treatments. Participants will be given the drug LBS-007 to see how well it works and if it is safe.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with relapsed or resistant acute leukaemia.
I cannot receive standard therapies that can help me.
I have an ECOG performance status of 0 to 2.
You may not be able to join if
I am currently receiving chemotherapy, radiation, or immunotherapy.
I have received any other experimental drugs within the last 30 days.
I have acute promyelocytic leukaemia or active CNS involvement.
I have had another active cancer in the last 2 years.
I have mental deficits or psychiatric issues that prevent me from giving consent.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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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 therap…
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.
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