NOVA-BCL6-1, A First-in-Human, Multicenter Phase Ia/Ib Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of LY4584180 in Adult Participants With Previously Treated Hematologic Malignancies

Study Identifier:
J6Y-OX-JBFA
CT.gov Identifier:
NCT07226843
EudraCT Identifier:
202552360116
EU Trial (CTIS) Number:
2025-523601-16-00
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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Study Summary

The main purpose of this study is to evaluate safety and efficacy, and measure how much LY4584180 gets into the bloodstream and how long it takes the body to eliminate it in patients with previously treated blood cancers. For each participant, the study could last about 9 months or possibly longer including screening.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Leukemia
Lymphoma, Non-Hodgkin's
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
N/A
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
Inclusion criteria
  • * Has been treated for the following blood cancers and has received at least 2 prior lines of systemic therapy or not eligible for available therapy: * Diffuse large B-cell lymphoma - not otherwise specified * High-grade B-cell lymphoma * Diffuse large B-cell lymphoma - transformed from indolent lymphomas * Follicular large B-cell lymphoma * Follicular lymphoma * Other non-Hodgkin lymphoma * Has measurable disease * Has discontinued all previous treatments for cancer and has recovered from the immediate effects of therapy
  • JRCT
  • Has been treated for the following blood cancers and has received at least 2 prior lines of systemic therapy or not eligible for available therapy:
  • * Diffuse large B-cell lymphoma - not otherwise specified
  • * High-grade B-cell lymphoma
  • * Diffuse large B-cell lymphoma - transformed from indolent lymphomas
  • * Follicular large B-cell lymphoma
  • * Follicular lymphoma
  • * Other non-Hodgkin lymphoma
  • - Has measurable disease
  • - Has discontinued all previous treatments for cancer and has recovered from the immediate effects of therapy
Exclusion criteria
  • Has an active second cancer * Has known central nervous system (CNS) involvement by systemic lymphoma. Patients with previous treatment for CNS involvement who are neurologically stable and without evidence of active CNS disease may be eligible and enrolled if a compelling clinical rationale is provided by the Investigator and with documented Sponsor approval. * Has known Cytomegalovirus infection. Participants with negative status are eligible * Has known hepatitis B or C infection or uncontrolled HIV * Has known significant heart disease
  • JRCT
  • Has an active second cancer
  • - Has known central nervous system (CNS) involvement by systemic lymphoma. Patients with previous treatment for CNS involvement who are neurologically stable and without evidence of active CNS disease may be eligible and enrolled if a compelling clinical rationale is provided by the Investigator and with documented Sponsor approval.
  • - Has known Cytomegalovirus infection. Participants with negative status are eligible
  • - Has known hepatitis B or C infection or uncontrolled HIV
  • - Has known significant heart disease

Clinical Study Information for Healthcare Providers

By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Daniel Morillo Giles
Status
Will Be Recruiting
Condition(s) Treated at Site
Leukemia
Lymphoma, Non-Hodgkin's