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NCT05004116 · ClinicalTrials.gov registry record · Phase 1
A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer
A Phase 1 study of Advanced Cancer and Metastatic Solid Tumor, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 77
- Enrollment target
- 1
- Study location
NCT05004116: Recruiting Phase 1 study of Advanced Cancer and Metastatic Solid Tumor, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05004116 is a Phase 1 study of Advanced Cancer and Metastatic Solid Tumor that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 77 participants, below the 246-participant average among 122 other Advanced Cancer trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05004116, a Phase 1 study of Advanced Cancer and Metastatic Solid Tumor, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 77 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test the safety of the study drug, repotrectinib, in combination with chemotherapy (irinotecan and temozolomide) in children and young adults who have advanced or metastatic solid tumors. We researchers will try to find the highest dose of the study drug that causes few or mild side effects in study participants. When the researchers find this dose, we will evaluate it in a different group of participants to find out whether repotrectinib in combination with chemotherapy is an effective treatment for children and young adults who have advanced/metastatic solid tumors. Another purpose of the study is to look at the way the body absorbs, distributes, and gets rid of repotrectinib.
Primary Outcome
DLTs will be defined as any of the following events that are possibly, probably or definitely attributable to TPX-0005 (Repotrectinib) given in combination with chemotherapy and occurring. Grading will be evaluated according to National Cancer Institute CTCAE v5.0.
Conditions Studied
Interventions
- DRUG Repotrectinib
- DRUG Irinotecan and temozolomide
Study Locations (1)
New York
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2021-08-09 |
| Est. Completion | 2028-08 |
| Phase | Phase 1 |
What NCT05004116 shows while recruiting
NCT05004116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 246-participant average among 122 other Advanced Cancer trials with a reported enrollment target (69% lower).
The record links to 2 conditions, with Advanced Cancer appearing as the primary indexed condition, and to 2 interventions - of which Repotrectinib is the first listed.
NCT05004116 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05004116 about?
NCT05004116 is a clinical study titled "A Study of Repotrectinib in Combination With Chemotherapy in Children and Young Adults With Solid Tumor Cancer". This study will test the safety of the study drug, repotrectinib, in combination with chemotherapy (irinotecan and temozolomide) in children and young adults who have advanced or metastatic solid tumors. We researchers will try to find the highest dose of the study drug that causes few or mild side ...
What is the current status of trial NCT05004116?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 77 participants. The study started on 2021-08-09. Estimated completion is 2028-08.
What conditions does trial NCT05004116 study?
This clinical trial studies the following conditions: Advanced Cancer, Metastatic Solid Tumor.
What interventions are being tested in trial NCT05004116?
The interventions under investigation include: Repotrectinib (DRUG), Irinotecan and temozolomide (DRUG).
Who is sponsoring clinical trial NCT05004116?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05004116 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05004116's enrollment target sits among peer trials
77 71st of 122 higher than 52 of 122 other Advanced Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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