A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations
NCT ID: NCT04094610
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
75 participants
INTERVENTIONAL
2020-03-12
2027-09-30
Brief Summary
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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.
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Detailed Description
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* Subjects \<12 years old will initially be enrolled in the Phase 1 part to determine the pediatric RP2D for this age group; once the pediatric RP2D is determined, subjects age \<12 years old may be enrolled into the Phase 2 part of the study.
* Subjects 12 to 25 years old will be directly enrolled into the Phase 2 part concurrent with Phase 1 enrollment.
Phase 1:
Approximately 12 pediatric subjects with locally advanced or metastatic solid tumors, including a primary central nervous system (CNS) tumor, or anaplastic large cell lymphoma (ALCL), with disease progression or who are non-responsive or intolerant to available therapies and for which no standard or available curative therapy exists.
Phase 2:
Subjects will be enrolled in one of 3 cohorts as follows:
Cohort 1: approximately 10-20 subjects with solid tumors characterized by NTRK fusion, TRK tyrosine kinase inhibitor (TKI)-naïve, and centrally confirmed measurable disease at baseline.
Cohort 2: approximately 23 subjects with solid tumors characterized by NTRK fusion, TRK TKI-pretreated, and centrally confirmed measurable disease at baseline.
Cohort 3: approximately 20 subjects with solid tumors or ALCL characterized by other ALK/ROS1/NTRK alterations or NTRK fusions without centrally confirmed measurable disease not otherwise eligible for Cohort 1 or 2. As of the current protocol amendment, only patients with ROS1 alterations will be enrolled to this cohort.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Repotrectinib (TPX-0005)
Phase 1
Oral repotrectinib (TPX-0005):
Safety and tolerability at different dose levels
Phase 2
Oral repotrectinib (TPX-0005): 3 cohorts
Cohort 1: TKI-naive NTRK fusion Cohort 2: Prior TKI NTRK fusion Cohort 3: ROS1 gene fusions or other ROS1 aberrations
Oral repotrectinib (TPX-0005)
Oral repotrectinib (TPX-0005)
Interventions
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Oral repotrectinib (TPX-0005)
Oral repotrectinib (TPX-0005)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
* 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.
Exclusion Criteria
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.
25 Years
ALL
No
Sponsors
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Turning Point Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Padua, , 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
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Leo Mascarenhas, Site 2111
Role: primary
Noah Federman, Site 2109
Role: primary
Margaret Macy, Site 2108
Role: primary
Tobey Macdonald, Site 2119
Role: primary
Stanley Chaleff, Site 2115
Role: primary
Steven Dubois, Site 2106
Role: primary
Andrew Cluster, Site 2113
Role: primary
Chad Jacobsen, Site 2121
Role: primary
Theodore Laetsch, Site 2117
Role: primary
Alberto Pappo, Site 2103
Role: primary
Tanya Carens Watt, Site 2101
Role: primary
Matthew McEvoy, Site 2118
Role: primary
Site 6104
Role: primary
Timothy Hassall, Site 6102
Role: primary
Nick Gottardo, Site 6101
Role: primary
Victor Lewis, Site 2202
Role: primary
Sunil desai, Site 2201
Role: primary
Lesleigh Abbott, Site 2203
Role: primary
Sebastien Perreault, Site 2205
Role: primary
Karsten Nysom, Site 4901
Role: primary
Site 6111
Role: primary
Emilie De Carli, Site 4203
Role: primary
Stephane Ducassou, Site 4201
Role: primary
Nadege Corradini, Site 4204
Role: primary
Nicolas Andre, Site 4205
Role: primary
Site 6110
Role: primary
Site 6112
Role: primary
Site 6109
Role: primary
Samuel Abbou, Site 4202
Role: primary
Site 6108
Role: primary
Michela Casanova, Site 4301
Role: primary
Site 4302
Role: primary
Allen Yeoh, Site 6401
Role: primary
Shui Yen Soh, Site 6402
Role: primary
Hyoung Jin Kang, Site 6301
Role: primary
Kyung Nam Koh, Site 6302
Role: primary
Alicia Castaneda Heredia, Site 4106
Role: primary
Elena Panizo Morgado, Site 4102
Role: primary
Site 6105
Role: primary
Maria Paula Perez Albert, Site 4103
Role: primary
Alvaro Lassaletta, Site 4105
Role: primary
Site 6106
Role: primary
Elena Panizo Morgado, Site 4101
Role: primary
Marta Osuna Marco, Site 4104
Role: primary
Jose Luis Moreno, Site 4108
Role: primary
Antonio Juan Ribelles, Site 4107
Role: primary
Site 6107
Role: primary
Shiann-Tarng Jou, Site 6202
Role: primary
Yen-Lin Liu, Site 6201
Role: primary
Lisa Howell, Site 4404
Role: primary
Madeleine Adams, Site 4401
Role: primary
Milind Ronghe, Site 4406
Role: primary
Linley Marchall, Site 4405
Role: primary
Elwira Szychot, Site 4402
Role: primary
References
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Wachter F, Al-Ibraheemi A, Trissal MC, Hollowell M, DuBois SG, Collins NB, Church AJ, Janeway KA. Molecular Characterization of Inflammatory Tumors Facilitates Initiation of Effective Therapy. Pediatrics. 2021 Dec 1;148(6):e2021050990. doi: 10.1542/peds.2021-050990.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA127-1029
Identifier Type: OTHER
Identifier Source: secondary_id
TPX-0005-07
Identifier Type: OTHER
Identifier Source: secondary_id
CA127-1029
Identifier Type: -
Identifier Source: org_study_id
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