I3Y-MC-JPCS: A Phase 1b/2 Study of Abemaciclib in Combination with Irinotecan and Temozolomide (Part A) and Abemaciclib in Combination with Temozolomide (Part B) in Pediatric and Young Adult Patients with Relapsed/Refractory Solid Tumors and Abemaciclib in Combination with Dinutuximab, GM-CSF, Irinotecan, and Temozolomide in Pediatric and Young Adult Patients with Relapsed/Refractory Neuroblastoma (Part C).

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506778-11-00

Acronym

I3Y-MC-JPCS

Enrollment

Registered

2024-04-08

Start date

2020-11-11

Completion date

2025-08-19

Last updated

2025-05-27

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

Conditions

Relapsed/Refractory Solid Tumors

Brief summary

Dose Limiting Toxicity (DLT), Maximum Tolerated Doses (MTD), PK (plasma concentrations of abemaciclib, irinotecan, and temozolomide)

Interventions

DRUGAbemaciclib

DRUGTEMOZOLOMIDE

DRUGVerzenios 50 mg film-coated tablets

DRUGIRINOTECAN

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Dose Limiting Toxicity (DLT), Maximum Tolerated Doses (MTD), PK (plasma concentrations of abemaciclib, irinotecan, and temozolomide)	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026