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NCT04683250 · ClinicalTrials.gov registry record · Phase 1
Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities
A Phase 1 study of RET-altered Non Small Cell Lung Cancer and RET-altered Solid Tumors, sponsored by Taiho Pharmaceutical Co..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 244
- Enrollment target
- 20
- Study locations
NCT04683250: Recruiting Phase 1 study of RET-altered Non Small Cell Lung Cancer and RET-altered Solid Tumors, sponsored by Taiho Pharmaceutical Co..
NCT04683250 is a Phase 1 study of RET-altered Non Small Cell Lung Cancer and RET-altered Solid Tumors that is actively recruiting participants, run by Taiho Pharmaceutical Co.. The registered enrollment target is 244 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (307% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04683250, a Phase 1 study of RET-altered Non Small Cell Lung Cancer and RET-altered Solid Tumors, is actively recruiting participants, sponsored by Taiho Pharmaceutical Co..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 244 participants
- Enrollment target
- 20
- Study locations
Study Summary
Phase 1 and 2 trial to study the safety, pharmacokinetics, and efficacy of TAS0953/HM06 in patients with advanced solid tumors with RET gene abnormalities. Phase 1 aims to determine the Maximum Tolerated Dose (MTD) and identify the Recommended Phase 2 Dose (RP2D) to be used in phase 2.
Primary Outcome
Incidence rate and category of dose limiting toxicities (DLTs)
Conditions Studied
Interventions
- DRUG TAS0953/HM06
Study Locations (20)
Other
- National Hospital Organization Kyushu Cancer Center - Fukuoka
- Kanagawa Cancer Center - Kanagawa
- Kurashiki Central Hospital - Okayama
California
- Chao Family Comprehensive Cancer Center - Orange
- Stanford Cancer Center - Stanford
Michigan
- Henry Ford Hospital - Detroit
- START Midwest - Cancer & Hematology Centers of Western Michigan - Grand Rapids
New York
- Laura and Isaac Perlmutter Cancer Center at NYU Langone Health - New York
- Memorial Sloan Kettering Cancer Center - New York
Osaka
- Kansai Medical University Hospital - Hirakata-shi
- Osaka International Cancer Institute - Osaka
Tokyo
- National Cancer Center Hospital - Chuo-ku
- The Cancer Institute Hospital of JFCR - Koto-ku
Massachusetts
- Massachusetts General Hospital - Boston
Tennessee
- The Sarah Cannon Research Institute/Tennessee Oncology - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2020-12-16 |
| Est. Completion | 2031-03 |
| Phase | Phase 1 |
What NCT04683250 shows while recruiting
NCT04683250 is an interventional study that assigns participants to a tested intervention. The registered 244 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (307% higher).
The record links to 2 conditions, with RET-altered Non Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which TAS0953/HM06 is the first listed.
NCT04683250 names 20 study sites across 13 states, led by Other, California, Michigan.
Frequently Asked Questions
What is clinical trial NCT04683250 about?
NCT04683250 is a clinical study titled "Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities". Phase 1 and 2 trial to study the safety, pharmacokinetics, and efficacy of TAS0953/HM06 in patients with advanced solid tumors with RET gene abnormalities. Phase 1 aims to determine the Maximum Tolerated Dose (MTD) and identify the Recommended Phase 2 Dose (RP2D) to be used in phase 2.
What is the current status of trial NCT04683250?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 244 participants. The study started on 2020-12-16. Estimated completion is 2031-03.
What conditions does trial NCT04683250 study?
This clinical trial studies the following conditions: RET-altered Non Small Cell Lung Cancer, RET-altered Solid Tumors.
What interventions are being tested in trial NCT04683250?
The interventions under investigation include: TAS0953/HM06 (DRUG).
Who is sponsoring clinical trial NCT04683250?
This trial is sponsored by Taiho Pharmaceutical Co., which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04683250 being conducted?
This trial has 20 study locations across California, Massachusetts, Michigan, New York, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04683250's enrollment target sits among peer trials
244 191st of 2000 higher than 1,808 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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