A Study of LY3295668 Erbumine in Participants With Relapsed/Refractory Neuroblastoma

August 20, 2026 updated by: Eli Lilly and Company

A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 Erbumine as a Single Agent and in Combination in Patients With Relapsed/Refractory Neuroblastoma

The reason for this study is to see if the study drug LY3295668 erbumine is safe in participants with relapsed/refractory neuroblastoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

71

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Perth Children's Hospital
  • Belgium
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • UZ Gent
  • France
      • Paris, France, 75248
        • Institut Curie
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69373 CEDEX 08
        • Centre Leon Berard
  • Germany
      • Cologne, Germany, 50924
        • Universitatsklinikum Koln
  • Italy
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Istituto Nazionale Dei Tumori
  • Japan
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
  • Spain
      • Madrid, Spain, 28009
        • Hospital Infantil Universitario Nino Jesus
    • Barcelona [Barcelona]
      • Barcelona, Barcelona [Barcelona], Spain, 8035
        • Hospital Universitari Vall d'Hebron
  • United Kingdom
      • Liverpool, United Kingdom, L14 5AB
        • Alder Hey Children's Hospital
  • United States
    • California
      • San Francisco, California, United States, 94158
        • UCSF Medical Center at Mission Bay
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago - Comer Children's Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Childrens Hospital Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • Texas
      • Houston, Texas, United States, 77030
        • Texas Childrens Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have relapsed/refractory neuroblastoma and have active disease in at least one site: bone, bone marrow or soft tissue. Participants must be able to submit an archival sample of tissue.
  • Participants must be able to swallow capsules.

Exclusion Criteria:

  • Participants must not have had an allogeneic hematopoietic stem cell, bone marrow, or solid organ transplant.
  • Participants must not have untreated tumor that has spread to the brain or spinal cord.
  • Participants must not have a serious active disease other than neuroblastoma.
  • Participants must not have a condition affecting absorption.
  • Participants must not have had prior aurora kinase inhibitor exposure.
  • Participants must not have a known allergy to the study treatment.
  • Participants must not have symptomatic human immunodeficiency virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LY3295668 Erbumine Escalation
LY3295668 Erbumine given orally.
Drug: LY3295668 Erbumine
Administered orally.
Experimental: LY3295668 Erbumine + Topotecan + Cyclophosphamide Escalation
LY3295668 Erbumine given orally and topotecan and cyclophosphamide given intravenously (IV).
Drug: LY3295668 Erbumine
Administered orally.
Drug: Topotecan
Administered IV.
Drug: Cyclophosphamide
Administered IV.
Experimental: LY3295668 Erbumine Expansion
LY3295668 Erbumine given orally.
Drug: LY3295668 Erbumine
Administered orally.
Experimental: LY3295668 Erbumine + Topotecan + Cyclophosphamide Expansion
LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV.
Drug: LY3295668 Erbumine
Administered orally.
Drug: Topotecan
Administered IV.
Drug: Cyclophosphamide
Administered IV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Dose Limiting Toxicities (DLTs)
Time Frame: Baseline through Cycle 2 (28 Day Cycle)
Number of Participants with DLTs
Baseline through Cycle 2 (28 Day Cycle)
Overall Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)
Time Frame: Baseline through Measured Progressive Disease (Estimated up to 5 Years)
ORR
Baseline through Measured Progressive Disease (Estimated up to 5 Years)
Duration of Response (DoR)
Time Frame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years)
DoR
Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Estimated up to 5 Years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3295668
Time Frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)
PK: AUC of LY3295668
Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)
PK: AUC of LY3295668 in Combination with Topotecan and Cyclophosphamide
Time Frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)
PK: AUC of LY3295668 in Combination with topotecan and cyclophosphamide
Cycle 1 Day 1 through Cycle 1 Day 15 (28 Day Cycles)
Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)
Time Frame: Baseline to Date of Objective Disease Progression (Estimated up to 5 Years)
BOR
Baseline to Date of Objective Disease Progression (Estimated up to 5 Years)
Progression-Free Survival (PFS)
Time Frame: Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years)
PFS
Baseline to Objective Progression or Death Due to Any Cause (Estimated up to 5 Years)
Overall Survival (OS)
Time Frame: Baseline to Date of Death from Any Cause (Estimated up to 6 Years)
OS
Baseline to Date of Death from Any Cause (Estimated up to 6 Years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

New Approaches to Neuroblastoma Therapy Consortium
Innovative Therapies for Children with Cancer in Europe (ITCC)

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2020

Primary Completion (Actual)

April 13, 2022

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

September 25, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 26, 2019

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 20, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17295
  • 2019 (U.S. NIH Grant/Contract: Chief Medical Office (CMO) Alberta Health Services)
  • 2019-01 (Other Identifier: NANT)
  • J1O-MC-JZHD (Other Identifier: Eli Lilly and Company)
  • 2019-001042-18 (EudraCT Number)
  • ITCC-085 (Other Identifier: ITCC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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