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Promising combo aims to outsmart aggressive brain tumors in kids

NCT ID NCT06413706

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This phase 2 trial tests whether adding the targeted drug abemaciclib to standard chemotherapy (temozolomide) helps children and young adults with newly diagnosed high-grade glioma live longer without their cancer growing. About 45 participants will receive either the combination or chemotherapy alone after radiotherapy. The study lasts about 11 months, with follow-up depending on how the tumor responds.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
abemaciclib (a targeted cancer drug) combined with temozolomide (chemotherapy)
What this could lead to
If successful, this combination could improve how long children and young adults with high-grade glioma live without their cancer growing, compared to standard chemotherapy alone.
What could go wrong
This is a small, early-phase (Phase 2) study with only 45 participants, so results may not apply to everyone. Adding abemaciclib may also increase side effects like fatigue or low blood counts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 20 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Biopsy proven high-grade glioma (HGG) as defined by 2016 World Health Organization (WHO) Classification Criteria, Grade 3-4 including: * Anaplastic astrocytoma * Anaplastic ganglioglioma * Anaplastic oligodendroglioma. * Anaplastic pleomorphic xanthoastrocytoma, * Glioblastoma OR as defined by the 2021 WHO Classification Criteria as molecularly characterized: * Non-pontine diffuse midline glioma, H3 K27-altered, * Diffuse hemispheric glioma, H3 G34-mutant * Diffuse pediatric HGG, H3/IDH-wildtype * Infant-type hemispheric glioma * High-grade astrocytoma with piloid features * High-grade pleomorphic xanthoastrocytoma * IDH-mutant diffuse glioma with homozygous cyclin- dependent kinase inhibitor 2A/B (CDKN2A/B) deletion, * IDH-mutant and 1p/19q co-deleted oligodendroglioma * IDH-mutant astrocytoma with homozygous CDKN2A/B deletion * Contraceptive use should be consistent with local regulations for participants in clinical studies. * Radiotherapy initiated within 6 weeks (+1 week) of diagnosis and administered over 6 weeks (±1 week). Participants \<3 years of age, considered not suitable for radiotherapy may be eligible. * Minimum of 4 weeks between completion of radiation and Cycle 1 Day 1 (C1D1). * Maximum of 8 weeks between completion of radiation and C1D1. Exceptional circumstances can be discussed with the medical monitor. * Acute effects of prior therapies must be Grade ≤1 unless deemed clinically insignificant by the investigator. * Adequate hematologic and organ function ≤7 days prior to C1D1 * Life expectancy of ≥8 weeks and deemed likely to complete at least 1 cycle of treatment. * A performance score of ≥60 using: 1. Lansky scale for participants \<16 years 2. Karnofsky scale for participants ≥16 years * Able to swallow and/or have a gastric/nasogastric tube. * Any current systemic steroid use dose must be stable or decreasing at least 7 days prior to C1D1. * Able and willing to adhere to study procedures, including frequent blood draws and MRI. * At least 28 days since any major surgery, laparoscopic procedure, or a significant traumatic injury. * Has a body surface area (BSA) of ≥0.2 m2. Exclusion Criteria: Participants are excluded if any of the following apply: * Diffuse Intrinsic Pontine Glioma (DIPG) or diffuse midline glioma located in the pons. * Recurrent or refractory HGG including any recurrence/progression during/after radiotherapy. * Secondary HGG, defined as a previously treated low-grade glioma that now meets high- grade criteria, or that resulted from a previously treated malignancy. * Have known pathogenic somatic mutations appropriate for an anaplastic lymphoma kinase (ALK), B-rapidly accelerated fibrosarcoma (BRAF), or neurotrophic tyrosine receptor kinase (NTRK ) inhibitor, in regions where these therapies are available and deemed appropriate by the investigator. * Prior HGG treatment (including bevacizumab), except for surgery and radiotherapy (with or without concomitant temozolomide). * Current enrollment in another trial deemed incompatible with this study. * Treatment with an investigational product within the last 30 days or 5 half-lives (whichever is longer). * Prior malignancy within the previous 3 years that, per the investigator and the medical monitor, may affect interpretation of study results. * A preexisting medical condition(s) that, per the investigator, would preclude study participation. * Any serious, active, systemic infection requiring IV antibiotic, antifungal, or antiviral therapy, including acute hepatitis B or C, or Human Immunodeficiency Virus at C1D1. * Intolerability or hypersensitivity such as urticaria, anaphylaxis, toxic necrolysis, and/or Stevens-Johnson syndrome to temozolomide, and/or abemaciclib, their excipients, or dacarbazine. * Received a live virus vaccine within 28 days of C1D1. * Pregnant, breastfeeding, or intend to become pregnant during the study.

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Conditions

The condition(s) this trial relates to.

brain cancer glioma malignant glioma neoplasm spinal cord neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

GLIOMA

Contacts and locations

Locations

  • Azienda Ospedaliera Di Rilievo Nazionale Santobono Pausilipon

    Naples, 80129, Italy

  • Centre Hospitalier Universitaire de Bordeaux Groupe Hospitalier Pellegrin Hopital des Enfants

    Bordeaux, 33076, France

  • Centre Leon Berard

    Lyon, 69008, France

  • Centre de Lutte Contre le Cancer (CLCC) - Centre Oscar Lambret

    Lille, 59020, France

  • Children's Hospital of Orange County - Orange

    Orange, California, 92868, United States

  • Copenhagen University Hospital-Rigshospitalet University Hospital

    Copenhagen, 2100, Denmark

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Universita Cattolica del Sacro Cuore

    Rome, 00168, Italy

  • Hopital La Timone

    Marseille, 13885, France

  • Hospital Clinico San Carlos

    Esplugues de Llobregat, 08950, Spain

  • Hospital Infantil Universitario Nino Jesus (HIUNJS)

    Madrid, 28009, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, 14004, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • IRCCS Ospedale Pediatrico Bambino Gesu

    Rome, 00165, Italy

  • Institut Curie

    Paris, 75005, France

  • Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP

    Villejuif, 94805, France

  • Institutul Oncologic Prof. Dr. Ion Chiricuta

    Cluj-Napoca, 400015, Romania

  • Lucile Packard Children's Hospital (LPCH) - Stanford University

    Palo Alto, California, 94304, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Nagoya University Hospital

    Nagoya, 466-8560, Japan

  • National Center for Child Health and Development (NCCHD)

    Setagaya-Ku Tokyo, 157-8535, Japan

  • Osaka City General Hospital

    Osaka, 534-0021, Japan

  • Perth Children's Hospital

    Nedlands, 6009, Australia

  • Princess Maxima Center for Voor Kinderoncologie B.V

    Utrecht, 3584 CS, Netherlands

  • Queensland Government- Lady Cilento Children's Hospital

    Brisbane, 4101, Australia

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Riley Hospital for Children at Indiana University Health

    Indianapolis, Indiana, 46202, United States

  • The Children's Hospital at Westmead

    Westmead, 2145, Australia

  • The Johns Hopkins Hospital (JHH) - Johns Hopkins Childrens Center

    Baltimore, Maryland, 21287, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UT Southwestern Medical Center Dallas/Childrens Medical Center

    Dallas, Texas, 75235, United States

  • Universitair Ziekenhuis Gent (Uz Gent)

    Ghent, 9000, Belgium

  • Universitair Ziekenhuis Leuven

    Leuven, 3000, Belgium

  • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

    Valencia, 46026, Spain

  • Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert, 1200, Belgium

  • University of Michigan Health System (UMHS) - C.S. Mott Children's Hospital - Hematology Oncology Clinic

    Ann Arbor, Michigan, 48109, United States

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