A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers
NOVA-BCL6-1, A First-in-Human, Multicenter Phase 1a/1b Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of LY4584180 in Adult Participants With Previously Treated Hematologic Malignancies
3 other identifiers
interventional
460
8 countries
46
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2026
Typical duration for phase_1
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2025
CompletedFirst Posted
Study publicly available on registry
November 12, 2025
CompletedStudy Start
First participant enrolled
April 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2030
July 17, 2026
July 1, 2026
12 months
November 7, 2025
July 16, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities
Number of Dose-Limiting Toxicities (DLTs) and DLT-Equivalent Toxicities
Baseline up to Day 28
Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline up to 3 Years
To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR)
To Evaluate the Preliminary Antitumor Activity of LY4584180: Objective Response Rate (ORR)
Baseline up to 3 Years
Secondary Outcomes (2)
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY4584180
Baseline to Day 8
PK: Area Under the Concentration (AUC) Versus Time Curve of LY4584180
Baseline to Day 8
Study Arms (4)
Phase 1a-Monotherapy Dose Escalation (Cohort A1)
EXPERIMENTALLY4584180 monotherapy administered orally
Phase 1a-Monotherapy Dose Optimization (Cohort A2)
EXPERIMENTALLY4584180 monotherapy administered orally
Phase 1b-Dose Expansion-Monotherapy (Cohort B1-B3)
EXPERIMENTALLY4584180 monotherapy administered orally
Phase 1b-Dose Expansion-Combination (Cohort B4)
EXPERIMENTALLY4584180 administered orally in combination with rituximab administered through IV infusion
Interventions
administered orally
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Mayo Clinic - Scottsdale
Scottsdale, Arizona, 85259, United States
City of Hope
Duarte, California, 91010, United States
University of California, Los Angeles (UCLA) - Medical Center
Los Angeles, California, 90059, United States
University of California, San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
University of Miami - Sylvester Cancer Center
Miami, Florida, 33136, United States
Florida Cancer Specialists - Sarasota
Sarasota, Florida, 34236, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Columbia University
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14618, United States
The Ohio State University (OSU)
Columbus, Ohio, 43210, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
Texas Oncology - DFW (Sammons CC)
Dallas, Texas, 75246, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Washington - Fred Hutchinson Cancer Center (Seattle Cancer Care Alliance)
Seattle, Washington, 98195, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
CHU de Nantes - Hotel-Dieu
Nantes, 44093, France
Institut Curie
Paris, 75005, France
CHU Bordeaux - Hopital Haut-Leveque - Centre Francois Magendie
Pessac, 33604, France
HCL Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Oncopole Claudius Regaud
Toulouse, 31059, France
Charite Universitaetsmedizin Berlin
Berlin, 10117, Germany
Universitaetsklinikum Koeln (AoeR)
Cologne, 50937, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
Universitaetsklinikum Frankfurt - Klinikum der Johann Wolfgang Goethe Universitaet
Frankfurt am Main, 60590, Germany
IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola
Bologna, 40138, Italy
Istituto Europeo di Oncologia
Milan, 20141, Italy
National Cancer Center Hospital East
Chiba, 277-8577, Japan
Okayama University Hospital
Okayama, 700-8558,, Japan
Cancer Institute Hospital of JFCR
Tokyo, 135-8550, Japan
Pratia Onkologia Katowice
Katowice, 40-519, Poland
Pratia MCM Krakow
Krakow, 30-727, Poland
AIDPORT Sp. z o.o.
Skorzewo, 60-185, Poland
Instytut Hematologii i Transfuzjologii w Warszawie
Warsaw, 02-776, Poland
Institut Catala d'Oncologia - L'Hospitalet
Barcelona, 08908, Spain
South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz
Madrid, 28040, Spain
King's College Hospital
London, SE5 9RS, United Kingdom
The Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
Nottingham City Hospital
Nottingham, NG5 1PB, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial question or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2025
First Posted
November 12, 2025
Study Start
April 17, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
February 1, 2030
Last Updated
July 17, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share