At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Oral repotrectinib (TPX-0005) (drug)
- How long the study runs
- Study runs about 90 months (dates as stated)
- About the drug or intervention
- Oral repotrectinib (TPX-0005) — drug: Oral repotrectinib (TPX-0005)
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- Up to 25 Years
- Who
- All
- Number of participants
- 75
- Started
- 2020-03-12
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for locally advanced solid tumors
- • Phase1/Phase2 - 75 participants
- • 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)
Who can take part?
- • Ages Up to 25 Years
- • Diagnosed with locally advanced solid tumors
Where?
- • Liverpool - Alder Hey Children's NHS Foundation Trust
- • Birmingham - Local Institution - 4403
- • Cardiff - University Hospital of Wales
- • Glasgow - Royal Hosp. for Children
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Enrollment of subjects into Phase 1 will proceed concurrently by age as follows: * 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 15 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 23 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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: Up to 25 Years
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ measurable disease by RECIST v1
- ✓ a Lansky (\< 16 years) or Karnofsky (≥ 16 years) score of at least 50
- ✓ prospectively confirmed measurable disease by BICR
What the study is looking for
- ✓Phase 1: Age \<12 years; Phase 2: Age 12- 25 years
- ✓Prior cytotoxic drug treatment is allowed.
- ✓Prior treatment that helps your immune system fight cancer is allowed.
- ✓All subjects must have cancer that can be measured on scans by (standard scan measurements) or Response Assessment in Neuro-Oncology (RANO) criteria at...
- ✓Subjects with a primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of...
See the full criteria
Where Is This Study? (6 UK sites)
Alder Hey Children's NHS Foundation Trust
Liverpool L12 2AP, United Kingdom
Local Institution - 4403
Birmingham B4 6DH, United Kingdom
University Hospital of Wales
Cardiff CF14 4XW, United Kingdom
Royal Hosp. for Children
Glasgow G51 4TF, United Kingdom
The Royal Marsden NHS Foundation Trust
London SW3 6JJ, United Kingdom
Great Ormond Street Hospital For Children NHS Foundation Trust
London WC1N 3JH, United Kingdom
How to Get in Touch
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Sponsor contactCONTACT
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Sponsor contactCONTACT
