Recruiting
Phase 1
Phase 2

LBS-007

Sponsor:

Lin BioScience, Inc

Code:

NCT05756322

Conditions

Relapsed or Resistant Acute Leukaemias

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LBS-007

Study Details

Brief 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. 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

Study ID

NCT05756322

Start date

Jul 20, 2023

Status verified date

Aug, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dose Finding and Expansion Phase

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)

Interventions

LBS-007

Open Label.

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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Lin BioScience Clinical Operations

+886975781753clinicaltrial@linbioscience.com

Locations

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

The University of Kansas Hospital

Recruiting

Fairway, Kansas, United States, 66205

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21287

UNC Hospitals, The University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

More Information

Sponsor

Lin BioScience, Inc

Last update posted

Mar 27, 2026

Last verified

Aug, 2025

Keywords

  • CDC7 inhibitor
  • LBS-007
  • AML
  • ALL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Lin BioScience, Inc on 2026-03-27.