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RecruitingLast updated: 23 July 2025

A study for people with acute lymphoblastic leukaemia (ALL) or acute myeloid leukaemia (AML) to investigate how safe, tolerable and effective treatment with a new targeted medicine is when given by itself and in combination with other drugsA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18 - 120

Clinical summary

Summary

This study has two phases.

In Phase 1 (Dose Finding), participants will receive LBS-007 by itself, or in combination with venetoclax and azacitidine. This phase aims to determine the appropriate dose level of LBS-007 when given alone or in combination with other treatments.

In Phase 2 (Dose Expansion), participants will receive LBS-007 by itself, or in combination with venetoclax and azacitidine at the optimal dose level identified in the previous phase. 

Conditions

This trial is treating people with acute lymphoblastic leukaemia or acute myeloid leukaemia that has relapsed or is resistant

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Lin BioScience, Inc

Scientific 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

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