RecruitingPhase 1Phase 2NCT04094610

A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

A Phase 1/2, Open-Label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, NTRK1-3 Alterations

Sponsor

Turning Point Therapeutics, Inc.

Enrollment

75 participants

Start Date

Mar 12, 2020

Study Type

INTERVENTIONAL

Conditions

Lymphoma Metastatic Solid Tumors Locally Advanced Solid Tumors Primary CNS Tumors

Summary

Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D). Phase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations.

Eligibility

Max Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study tests repotrectinib — a targeted therapy — in children and young adults who have solid tumors with specific genetic changes: ROS1 fusions, NTRK1-3 fusions, or ALK alterations. These genetic changes drive cancer growth, and repotrectinib is designed to block them. **You may be eligible if...** - You are under 25 years old (under 12 for Phase 1; 12–25 for Phase 2) - Your tumor has a confirmed ROS1 or NTRK genetic change (or ALK alteration) - You have measurable cancer that can be tracked by imaging - You have recovered from side effects of any previous cancer treatments **You may NOT be eligible if...** - You have neuroblastoma with only bone marrow involvement - You had major surgery within the past 2 weeks - You have an active infection including HIV - You have bowel conditions that would prevent absorbing the medication - You have significant heart rhythm problems - You have significant nerve damage (neuropathy) from prior treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOral repotrectinib (TPX-0005)

Oral repotrectinib (TPX-0005)

Locations(68)

Children's Hospital Los Angeles

Los Angeles, California, United States

University of California at Los Angeles

Los Angeles, California, United States

Children's Hospital Colorado - Anschutz Medical Campus

Aurora, Colorado, United States

Local Institution - 2105

Orlando, Florida, United States

Local Institution - 2120

Orlando, Florida, United States

Children's Healthcare of Atlanta - Egleston Hospital

Atlanta, Georgia, United States

Maine Medical Center

Scarborough, Maine, United States

Dana Farber Cancer Institute.

Boston, Massachusetts, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Local Institution - 2110

New Brunswick, New Jersey, United States

Local Institution - 2102

New York, New York, United States

Levine Children's Hospital- Pediatric Neuro-Oncology

Charlotte, North Carolina, United States

Local Institution - 2112

Cleveland, Ohio, United States

Local Institution - 2114

Hershey, Pennsylvania, United States

Children's Hospital of Philadelphia-Center for Childhood Cancer Research

Philadelphia, Pennsylvania, United States

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

The University of Texas Southwestern Medical Center - Harold C Simmons Comprehensive Cancer Center

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Local Institution - 2104

Houston, Texas, United States

Children's Hospital of Richmond at VCU

Richmond, Virginia, United States

Local Institution - 6104

Randwick, New South Wales, Australia

Local Institution - 6103

Westmead, New South Wales, Australia

Children's Health Queensland Hospital and Health Service

South Brisbane, Queensland, Australia

Perth Childrens Hospital

Nedlands, Western Australia, Australia

University Of Calgary

Calgary, Alberta, Canada

Stollery Children'S Hospital

Edmonton, Alberta, Canada

Children'S Hospital Of Eastern Ontario

Ottawa, Ontario, Canada

St Justine Hospital

Montreal, Quebec, Canada

Rigshospitalet - Glostrup

Copenhagen, Denmark

Local Institution - 6111

Lyon, Rhone, France

Centre Hospitalier Universitaire D'Angers

Angers, France

Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Pellegrin

Bordeaux, France

Institut d Hematologie et d Oncologie Pediatriques

Lyon, France

Hôpitaux Universitaires de Marseille Timone

Marseille, France

Local Institution - 6110

Marseille, France

Local Institution - 6112

Nantes, France

Local Institution - 6109

Paris, France

Institut Gustave-Roussy

Villejuif, France

Local Institution - 6108

Villejuif, France

Fondazione IRCCS - Istituto Nazionale dei Tumori

Milan, Italy

Local Institution - 6113

Padova, Italy

Local Institution - 4302

Rome, Italy

Local Institution - 6114

Torino, Italy

National University Hospital

Singapore, Singapore

KK Women's and Children's Hospital

Singapore, Singapore

Local Institution - 6303

Seoul, Seodaemun-gu, South Korea

Seoul National University Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Local Institution - 6304

Seoul, South Korea

Hospital Sant Joan De Deu

Esplugues de Llobregat, Barcelona, Spain

Clínica Universidad de navarra

Pamplona, Navarre, Spain

Local Institution - 6105

Barcelona, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Infantil Universitario Nino Jesus

Madrid, Spain

Local Institution - 6106

Madrid, Spain

Clinica Universidad de Navarra

Madrid, Spain

HM Sanchinarro University Hospital

Madrid, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Universitario Y Politecnico La Fe

Valencia, Spain

Local Institution - 6107

Valencia, Spain

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Alder Hey Children's NHS Foundation Trust

Liverpool, England, United Kingdom

Local Institution - 4403

Birmingham, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

Royal Hosp. for Children

Glasgow, United Kingdom

The Royal Marsden NHS Foundation Trust

London, United Kingdom

Great Ormond Street Hospital For Children NHS Foundation Trust

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04094610

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