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RECRUITING

NCT04094610

PHASE1/PHASE2

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

Sponsor: Turning Point Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - 25 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-03-12

Completion Date

2027-09-30

Last Updated

2025-11-19

Healthy Volunteers

Conditions

Locally Advanced Solid Tumors Metastatic Solid Tumors Lymphoma Primary CNS Tumors

Interventions

DRUG

Oral repotrectinib (TPX-0005)

Key Inclusion Criteria: 1. Documented genetic ROS1 point mutation, fusion, or amplification or NTRK1-3 fusion as identified by local testing in a Clinical Laboratory Improvement Amendments (CLIA) laboratory in the US or equivalently accredited diagnostic lab outside the United States (US) is required. 2. Phase 1: Age \<12 years; Phase 2: Age 12- 25 years 3. Prior cytotoxic chemotherapy is allowed. 4. Prior immunotherapy is allowed. 5. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1. 6. All subjects must have measurable disease by RECIST v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria at time of enrollment. 7. Subjects with a primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 7 days prior to enrollment. 8. Subjects must have a Lansky (\< 16 years) or Karnofsky (≥ 16 years) score of at least 50. 9. Life expectancy greater than or equal to 12 weeks, in the investigator's opinion. 10. Adequate hematologic, renal and hepatic function. Phase 2 Inclusion Criteria: 1. Cohort Specific Inclusion Criteria: * Cohort 1: Subjects with NTRK fusion gene positive (NTRK+) advanced solid tumors (including primary CNS tumors), that are tropomyosin receptor kinase (TRK) TKI naïve; * Cohort 2: subjects with NTRK+ advanced solid tumors (including primary CNS tumors), that are TRK TKI pre-treated; * Cohort 3: subjects with advanced solid tumors with ROS1 gene fusions or other ROS1 aberrations (including amplifications and point mutations) with measurable disease. 2. Subjects in Cohorts 1 and 2 must have prospectively confirmed measurable disease by BICR prior to enrollment. Key Exclusion Criteria (Phase 1 and Phase 2): 1. Subjects with neuroblastoma with only bone marrow disease evaluable by bone marrow aspiration only. 2. Major surgery within 14 days (2 weeks) of start of repotrectinib treatment. Central venous access (Broviac, Mediport, etc.) placement does not meet criteria for major surgery. 3. Known active infections requiring ongoing treatment (bacterial, fungal, viral including HIV positivity). 4. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption. 5. Any of the following cardiac criteria: * Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) \> 480 msec obtained from three ECGs, using the screening clinic ECG machine-derived QTc value * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \> 250 msec) * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval 6. Peripheral neuropathy of CTCAE ≥grade 2. 7. Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers. 8. Any potential allergies to repotrectinib and/or its excipients.

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (68)