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Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors

A Phase I/II Study of Brigatinib in Pediatric and Young Adult Patients With ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or Other Solid Tumors

NCT04925609•Princess Maxima Center for Pediatric Oncology

View on ClinicalTrials.gov

Summary

Detailed Description

This is an open-label, phase I-II dose-escalation and expansion study designed to define the recommended dose of brigatinib as monotherapy in pediatric and young adult patients with ALK+ ALCL, IMT or other solid tumors and to evaluate the pharmacokinetics (PK), (long-term) safety, and efficacy of brigatinib in these children. Phase 1 part will be a dose escalation part using a rolling-6 design, aiming to accrue a minimum of 6 and a maximum of 18 evaluable patients in two dose-levels (and minus 1), at least 2/3 of included patients will be ≤18 years. Phase 2 will be the tumor cohort expansion part of the study to further evaluate the safety, tolerability, and clinical activity/efficacy of brigatinib as monotherapy in two tumor-specific cohorts: * Cohort B1: ALK+ IMT Planned sample size for Phase 2 is 12 patients with IMT. Patients who are included in the monotherapy Phase 1 IMT dose-escalation portion of the study will be included in the expansion cohort analysis if they receive the RP2D, and will count towards the total sample size of 12 patients. * Cohort B2: ALK+ ALCL Planned sample size for Phase 2 is 22 patients with ALCL. Patients who are included in the monotherapy Phase 1 ALCL dose-escalation portion of the study will be included in the expansion cohort analysis if they receive the RP2D, and will count towards the total sample size of 22 patients.

Eligibility

Age

1 - 25 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients must be 1 and \< 26 years of age at the time of enrollment, and able to swallow brigatinib tablets at the time of enrollment, with a minimum weight of 10 kg. Note: for phase 1 only patients ≤18 years old will be eligible, A liquid formulation for children with a weight lower than 10 kg or for those that cannot swallow tablets is in development.
•2. Patients must have a confirmed diagnosis of cancer histologically at baseline. In patients where a repeat biopsy at relapse (or moment of refractory disease) is considered not feasible by the treating physician, archived material from diagnosis needs to be available for central review.
•3. Patients are required to provide prior results showing an activating ALK aberration in the tumor per local laboratory results, and material needs to be available for central laboratory confirmation of ALK status. For ALK+ ALCL, detection of ALK with immunohistochemistry (IHC) is sufficient for inclusion, all others require molecular evidence of a ALK fusion gene or mutation by FISH, PCR or NGS. ALK detection will be confirmed centrally with FISH.
•4. For Phase 1:
•* Patients with ALCL must be relapsed/refractory or intolerant to standard therapies. Refractory disease for ALCL is defined as:
•o no response to ALCL99/other standard of care chemotherapy (SD or PD of measurable lesions), and/or
•o MRD-positivity by qualitative PCR for NPM-ALK prophase after one block ALCL99/other standard of care chemotherapy (before the second course of chemotherapy).
•* Patients with relapsed/refractory (R/R) IMT must not be suitable for curative surgical resection without causing mutilation. Newly diagnosed patients with unresectable ALK+ IMT, or when surgery would imply severe mutilation may also be included, as well as metastatic disease.
•* Patients with other solid tumors (excluding IMT) must have relapsed or refractory disease.
•5. For Phase 2, patients must have measurable and/or evaluable disease:
+39 more criteria

Exclusion Criteria

•1. Patients receiving systemic treatment with strong or moderate CYP3A inhibitors or inducers within 14 days or five half-life times whichever the less prior to the first dose of study drug (refer to Section 5.2 for a list of example medications).
•2. Diagnosis of another concurrent primary malignancy.
•3. Clinically significant cardiovascular disease, including any of the following:
•* Myocardial infarction or unstable angina within 6 months of study entry.
•* History of or presence of heart block, and/or clinically significant ventricular or atrial arrhythmias.
•* Uncontrolled hypertension defined as persistent elevation of systolic and/or diastolic blood pressures to ≥95th percentile based on age, sex, and height percentiles despite appropriate antihypertensive management.
•4. Planned non-protocol chemotherapy, radiation therapy, another investigational agent, or immunotherapy while patient is on study treatment.
•5. Any illness that affects gastrointestinal absorption.
•6. Ongoing or active systemic infection, active seropositive HIV, or known active hepatitis B or C infection.
•7. Any pre-existing condition or illness that, in the opinion of the investigator or sponsor, would compromise patient safety or interfere with the evaluation of the safety or efficacy of brigatinib.
+1 more criteria

Locations (2)

Institut Gustave Roussy

Paris, France

Princess Máxima Center for Pediatric Oncology

Utrecht, Utrecht, Netherlands

Key Dates

Start Date

August 18, 2022

Primary Completion Date

December 1, 2033

Completion Date

December 1, 2033

Last Updated

December 5, 2025

Enrollment

ESTIMATED participants

Conditions

Anaplastic Large Cell Lymphoma, ALK-PositiveInflammatory Myofibroblastic TumorOther Solid Tumor

Interventions

Brigatinib

DRUG

Contacts

Maaike Boonstra

CONTACT

+31642055985 m.boonstra@prinsesmaximacentrum.nl

Gertruud Bakker

CONTACT

+31889727272 G.C.M.Bakker-7@prinsesmaximacentrum.nl

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors

Inclusion Criteria

Exclusion Criteria

Phase I Clinical Study of BL-M07D1 in Locally Advanced or Metastatic Digestive Tract Tumors and Other Solid Tumors

Chemoimmunotherapy for ALK+ Relapsed/Refractory ALCL

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KD6001 in Combination With Anti-PD-1 Antibody±Bevacizumab in Patients With Advanced HCC and Other Solid Tumors

Pilot Study of Crizotinib in Relapsed ALK+ Lymphomas