Evaluating LBS-007 for patients with relapsed or resistant acute leukaemias

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

This study is testing a new drug called LBS-007 to see if it can safely help people with relapsed or resistant acute leukaemias, like ALL and AML, who have run out of other treatment options.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years to 120 Years
• Sex: All
• Sponsor: Lin BioScience, Inc (industry)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 17 sites (Tampa, Florida and 16 other locations)
• Trial ID: NCT05756322 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and tolerability of LBS-007, a CDC7 inhibitor, in patients suffering from relapsed or resistant acute leukaemias, specifically acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML). The study aims to determine the maximum tolerated dose (MTD) of LBS-007 while also assessing its efficacy and pharmacokinetics. Participants will be closely monitored for any adverse effects and changes in surrogate biomarkers in response to treatment. This trial is particularly focused on patients who have exhausted standard treatment options.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old with pathologically confirmed relapsed or resistant AML or ALL who are ineligible for standard therapies.

Not a fit: Patients with acute promyelocytic leukaemia, active CNS involvement, or those currently receiving other investigational agents may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with limited or no effective treatment alternatives for acute leukaemias.

How similar studies have performed: While this approach is novel in the context of LBS-007, similar studies targeting acute leukaemias with new agents have shown promise in the past.

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 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.

Where this trial is running

Tampa, Florida and 16 other locations

• Moffitt Cancer Center — Tampa, Florida, United States (RECRUITING)
• Robert H. Lurie Comprehensive Cancer Center of Northwestern University — Chicago, Illinois, United States (NOT_YET_RECRUITING)
• The University of Kansas Hospital — Fairway, Kansas, United States (RECRUITING)
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States (RECRUITING)
• UNC Hospitals, The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)
• Wollongong Private Hospital — Wollongong, New South Wales, Australia (COMPLETED)
• Pindara Private Hospital — Benowa, Queensland, Australia (COMPLETED)
• The Royal Adelaide Hospital — Adelaide, South Australia, Australia (RECRUITING)
• The Alfred Hospital — Melbourne, Victoria, Australia (ACTIVE_NOT_RECRUITING)
• Hollywood Private Hospital — Nedlands, Washington, Australia (WITHDRAWN)
• Q Medical Conselling — Perth, Washington, Australia (WITHDRAWN)
• The First Affiliated Hospital of Xinxiang Medical University — Xinxiang, Henan, China (RECRUITING)
• Jining No.1 People's Hospital — Jining, Shandong, China (RECRUITING)
• Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, China (RECRUITING)
• China Medical University Hospital — Taichung, Taiwan (NOT_YET_RECRUITING)
• National Cheng Kung University Hospital — Tainan, Taiwan (NOT_YET_RECRUITING)
• National Taiwan University Hospital — Taipei, Taiwan (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Lin BioScience Clinical Operations

Conditions: Relapsed or Resistant Acute Leukaemias, CDC7 inhibitor, LBS-007, AML, ALL