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

A Phase 1 Study of Aurora Kinase A Inhibitor LY3295668 erbumine as a Single Agent and in Combination in Patients with Relapsed/Refractory Neuroblastoma - J1O-MC-JZHD

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200270

Enrollment

Registered

2020-12-24

Start date

2021-01-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patieints with relapsed/refractory neuroblastoma

Interventions

LY3295668 Erbumine Administered orally LY3295668 Erbumine given orally and topotecan and cyclophosphamide given IV.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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. - Participant s 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.

Design outcomes

Primary

Measure	Time frame
1. Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 2 (28 Day Cycle) ] Number of Participants with DLTs 2. 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 3. 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	—

Measure

Time frame

1. Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 2 (28 Day Cycle) ] Number of Participants with DLTs 2. 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 3. 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

—

Countries

Australia, Belgium, Canada, France, Germany, Italy, Japan, Spain, United Kingdom, United States

Contacts

Public ContactTrial Guide Call Center

Eli Lilly Japan K.K.

LTG_CallCenter@lists.lilly.com+81-120-023-812

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026