A Phase 1/2 interventional study of Oral repotrectinib (TPX-0005) in Locally Advanced Solid Tumors, Metastatic Solid Tumors and Lymphoma, sponsored by Turning Point Therapeutics, Inc.. Recruiting at 68 sites in 11 countries. Open to participants aged Up to 25 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Turning Point Therapeutics, Inc. (part of Bristol-Myers Squibb) · Phase 1/2, Interventional, and Treatment
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.
Enrollment of subjects into Phase 1 will proceed concurrently by age as follows:
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.
3,018 studies on the registry are indexed under Lymphoma; 434 are open to participants now.
This study's planned enrollment of 75 is above the median of 43 across 2,319 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Turning Point Therapeutics, Inc. is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
First submitted before Turning Point Therapeutics, Inc. became part of Bristol-Myers Squibb.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Phase 2 Inclusion Criteria:
Cohort Specific Inclusion Criteria:
Key Exclusion Criteria (Phase 1 and Phase 2):
Any of the following cardiac criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Oral repotrectinib (TPX-0005)
Oral repotrectinib (TPX-0005)
Also known as: Oral repotrectinib (TPX-0005) capsules, Oral repotrectinib (TPX-0005) oral suspension, repotrectinib
Dose limiting toxicities (DLTs) (Phase 1)
Define the dose limiting toxicities (DLTs) (Phase 1)
Time frame: Within 28 days of the first repotrectinib dose
Pediatric Recommended Phase 2 Dose (RP2D) (Phase 1)
To determine the pediatric RP2D (Phase 1)
Time frame: Within 28 days of the last patient dosed in escalation
Overall Response Rate (ORR) (Phase 2)
To determine the confirmed ORR of repotrectinib (TPX-0005) as assessed by Blinded Independent Central Review (Phase 2)
Time frame: Two to three years after first dose of repotrectinib
Overall Response Rate (ORR) (Phase 1)
To determine the overall response rate (ORR) by Blinded Independent Central Review (BICR) (Phase 1)
Time frame: Approximately three years
Clinical Benefit Rate (CBR) (Phase 1 and Phase 2)
To determine the CBR of repotrectinib (TPX-0005) (Phase 1 and Phase 2)
Time frame: Approximately three years
Time to response (TTR) (Phase 1 and Phase 2)
To determine the TTR of reprotrectinib (TPX-005) (Phase 1 and Phase 2)
Time frame: Approximately three years
Duration of response (DOR) (Phase 1 and Phase 2)
To determine the DOR of repotrectinib (TPX-0005) (Phase 1 and Phase 2)
Time frame: Approximately three years
Intracranial objective response rate (IC-ORR) (Phase 1 and Phase 2)
To determine the IC-ORR of repotrectinib in subjects with measurable brain metastases (TPX-005) (Phase 1 and Phase 2)
Time frame: Approximately three years
Central Nervous System Progression-Free Survival (CNS-PFS) (Phase 2)
CNS-PFS in subjects with measurable brain metastases (Phase 2)
Time frame: Approximately three years
Progression-free survival (PFS) (Phase 2)
To determine the PFS (Phase 2)
Time frame: Approximately three years
Overall survival (OS) (Phase 2)
To determine the OS (Phase 2)
Time frame: Approximately three years
Maximum concentration of repotrectinib in plasma (Cmax)
To determine the Cmax
Time frame: Pre-dose and up to 24 hours post-dose on Day 1 and Day 15 in Cycle 1 (each cycle is 28 days)
Area under the concentration versus time curve of repotrectinib in plasma (AUC)
To determine the AUC
Time frame: Pre-dose and up to 24 hours post-dose on Day 1 and Day 15 in Cycle 1 (each cycle is 28 days)
Number of participants with laboratory abnormalities
Time frame: Approximately three years
Number of Participants with Adverse events
Time frame: Approximately three years
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Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
Started Mar 2020 (actual). Primary completion is estimated for Sep 2026, 78 months after the start.
Of 66 industry-sponsored phase 1/2 interventional studies under Lymphoma, half reached primary completion within 65 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 87. This study's planned 78 months is above that.
Counting every sponsor, half of 143 studies reached it within 74 months; a quarter within 48 and three quarters within 111.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Repotrectinib
Turning Point Therapeutics, Inc. →