Repotrectinib Clinical Trials (2026): 13 Studies for Healthy Volunteers & Metastatic Solid Tumor
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
13 Repotrectinib clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 11 indications (including Healthy Volunteers & Metastatic Solid Tumor) and 1,010 total planned enrollment. 1 Phase 3 Repotrectinib trial and 3 Phase 2 are listed. 5 Repotrectinib clinical trials are actively recruiting at 23 U.S. sites across 14 states. Most recent activity: NCT06552234 (Sep 2031).
Where to Participate: All Repotrectinib Trial Sites in the U.S. (23 sites across 14 states)
Every actively recruiting Repotrectinibtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| CA | Children's Hospital Los Angeles | Los Angeles90027-6062 | NCT04094610 | Map |
| CA | University of California at Los Angeles | Los Angeles90095 | NCT04094610 | Map |
| CA | St Joseph Heritage Healthcare | Santa Rosa95403 | NCT03093116 | Map |
| CO | Children's Hospital Colorado - Anschutz Medical Campus | Aurora80045 | NCT04094610 | Map |
| FL | Memorial Healthcare System | Hollywood33021 | NCT03093116 | Map |
| GA | University Cancer and Blood Center | Athens30607 | NCT03093116 | Map |
| GA | Children's Healthcare of Atlanta - Egleston Hospital | Atlanta30329 | NCT04094610 | Map |
| IL | University of Chicago | Chicago60637 | NCT03093116 | Map |
| ME | Maine Medical Center | Scarborough04074 | NCT04094610 | Map |
| MA | Dana Farber Cancer Institute. | Boston02215 | NCT04094610 | Map |
| MA | Massachusetts General Hospital, | Boston02114 | NCT03093116 | Map |
| MO | Washington University Infusion Center Pharmacy | St Louis63110 | NCT03093116 | Map |
| MO | Washington University School of Medicine in St. Louis | St Louis63110 | NCT04094610 | Map |
| NY | Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York10065 | NCT05004116 | Map |
| NC | Levine Children's Hospital- Pediatric Neuro-Oncology | Charlotte28203 | NCT04094610 | Map |
| OH | The Ohio State University Wexner Medical Center | Columbus43210 | NCT03093116 | Map |
| PA | Children's Hospital of Philadelphia-Center for Childhood Cancer Research | Philadelphia19104 | NCT04094610 | Map |
| TN | Baptist Memorial Hospital Baptist Cancer Center | Memphis38120 | NCT03093116 | Map |
| TN | St. Jude Children's Research Hospital | Memphis38015 | NCT04094610 | Map |
| TX | The University of Texas Southwestern Medical Center - Harold C Simmons Comprehensive Cancer Center | Dallas75390 | NCT04094610 | Map |
| TX | UT Southwestern Medical Center | Dallas75390 | NCT03093116 | Map |
| TX | Baylor College of Medicine | Houston77030 | NCT04094610 | Map |
| TX | MD Anderson Cancer Center | Houston77030 | NCT03093116 | Map |
Repotrectinib clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | terminated | withdrawn | unknown | available | Total |
|---|---|---|---|---|---|---|---|---|
| P1 | 3 | 1 | 1 | 5 | ||||
| P1/P2 | 3 | 3 | ||||||
| P2 | 2 | 1 | 3 | |||||
| P3 | 1 | 1 | ||||||
| N/A | 1 | 1 |
Recruiting Repotrectinib clinical trials (5)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT06552234 | REPOROSPhase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC | P2 | NSCLC Stage IV | 30 | Oct 2024 |
| NCT05004116 | A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer | P1/P2 | Advanced Cancer | 77 | Aug 2021 |
| NCT06315010 | REPOSEREPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis | P2 | NSCLC | 20 | Jun 2025 |
| NCT03093116 | TRIDENT-1A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements | P1/P2 | Locally Advanced Solid Tumors | 500 | Mar 2017 |
| NCT04094610 | A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations | P1/P2 | Locally Advanced Solid Tumors | 75 | Mar 2020 |
Repotrectinib clinical trials by indication
Healthy Volunteers (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07223671 | — | P1 | completed | Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants |
| NCT06493409 | — | P1 | completed | A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants |
Locally Advanced Solid Tumors (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03093116 | TRIDENT-1 | P1/P2 | recruiting | A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements |
| NCT04094610 | — | P1/P2 | recruiting | A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations |
NSCLC (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06315010 | REPOSE | P2 | recruiting | REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis |
NSCLC Stage IV (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06552234 | REPOROS | P2 | recruiting | Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC |
Hormone Receptor-positive Human Epidermal Growth Factor 2-negative (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06408168 | — | P2 | terminated | Phase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negative Metastatic Invasive LObular Carcinoma Who Received a Prior Endocrine Therapy in Combination With Cyclin-dependent Kinase 4 and 6 Inhibitor (REPLOT Trial) |
Hepatic Impairment (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06352528 | — | P1 | completed | A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment |
Carcinoma, Non-Small-Cell Lung (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06140836 | TKI | P3 | active not recruiting | A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3) |
Locally Advanced Solid Tumor (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05828277 | — | P1 | withdrawn | A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients |
Nsclc (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04772235 | TOTEM | P1 | unknown | Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients |
Advanced Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05004116 | — | P1/P2 | recruiting | A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer |
Other (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05926232 | — | N/A | available | Expanded Access for Repotrectinib |
Repotrectinib pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| TKI | NCT06140836 | P3 | active not recruiting | Carcinoma, Non-Small-Cell Lung | 190 | — |
| REPOROS | NCT06552234 | P2 | recruiting | NSCLC Stage IV | 30 | — |
| REPOSE | NCT06315010 | P2 | recruiting | NSCLC | 20 | — |
Terminated and withdrawn Repotrectinib trials (2)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT05828277withdrawnA Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients
- NCT06408168terminatedPhase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negative Metastatic Invasive LObular Carcinoma Who Received a Prior Endocrine Therapy in Combination With Cyclin-dependent Kinase 4 and 6 Inhibitor (REPLOT Trial)
All Repotrectinib trials (13)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT06552234 | REPOROS | Phase II Efficacy Study of Repotrectinib in Frail and/or Elderly Patients With ROS1-rearranged Advanced NSCLC | P2 | recruiting | 30 | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer | Oct 2024 |
| NCT05004116 | A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer | P1/P2 | recruiting | 77 | Memorial Sloan Kettering Cancer Center | Aug 2021 | |
| NCT06315010 | REPOSE | REPotrectinib in ROS1-positive Non-small Cell Lung Cancer Patients With Active Brain mEtastasis | P2 | recruiting | 20 | MedSIR | Jun 2025 |
| NCT03093116 | TRIDENT-1 | A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements | P1/P2 | recruiting | 500 | Turning Point Therapeutics, Inc. | Mar 2017 |
| NCT04094610 | A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations | P1/P2 | recruiting | 75 | Turning Point Therapeutics, Inc. | Mar 2020 | |
| NCT06140836 | TKI | A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3) | P3 | active not recruiting | 190 | Bristol-Myers Squibb | Dec 2023 |
| NCT04772235 | TOTEM | Phase I Study of Repotrectinib and Osimertinib in NSCLC Patients | P1 | unknown | 32 | Instituto Oncológico Dr Rosell | Feb 2022 |
| NCT07223671 | Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants | P1 | completed | 30 | Bristol-Myers Squibb | Dec 2025 | |
| NCT05828277 | A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer Patients | P1 | withdrawn | 0 | Turning Point Therapeutics, Inc. | Jul 2022 | |
| NCT06408168 | Phase II Study of REPotrectinib With or Without Fulvestrant in Patients With Hormone Receptor-positive Human Epidermal Growth Factor 2-negative Metastatic Invasive LObular Carcinoma Who Received a Prior Endocrine Therapy in Combination With Cyclin-dependent Kinase 4 and 6 Inhibitor (REPLOT Trial) | P2 | terminated | 6 | M.D. Anderson Cancer Center | Aug 2024 | |
| NCT06352528 | A Study to Assess the Drug Levels of Repotrectinib in Healthy Participants and Participants With Moderate and Severe Hepatic Impairment | P1 | completed | 18 | Bristol-Myers Squibb | Apr 2024 | |
| NCT06493409 | A Study to Assess the Effect of Voriconazole and Quinidine on the Pharmacokinetics of a Single Dose of Repotrectinib in Healthy Participants | P1 | completed | 32 | Bristol-Myers Squibb | Aug 2024 | |
| NCT05926232 | Expanded Access for Repotrectinib | — | available | 0 | Bristol-Myers Squibb | — |
Repotrectinib clinical trials: frequently asked questions
- How many Repotrectinib clinical trials are there?
- 13 Repotrectinib clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 5 are actively recruiting participants. 3 are marked completed.
- Are Repotrectinib clinical trials recruiting in 2026?
- Yes — 5 Repotrectinib trials are actively recruiting in 2026, with 23 U.S. sites across 14 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Repotrectinib being studied for?
- Repotrectinib is being studied for Healthy Volunteers, Metastatic Solid Tumor, Metastatic Solid Tumors, Locally Advanced Solid Tumors, Hormone Receptor-positive Human Epidermal Growth Factor 2-negative and 13 more. The trials are grouped by indication on this page.
- What phase is Repotrectinib in?
- Repotrectinib clinical trials span 1 Phase 3, 3 Phase 2, 5 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Repotrectinib clinical trials?
- The lead sponsor across the most Repotrectinib trials is Bristol-Myers Squibb, with 6 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Repotrectinibas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
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