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NCT05948475 · ClinicalTrials.gov registry record · Phase 3
Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma
A Phase 3 study of Cholangiocarcinoma, sponsored by TransThera Sciences (Nanjing).
- Recruiting
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT05948475: Recruiting Phase 3 study of Cholangiocarcinoma, sponsored by TransThera Sciences (Nanjing).
NCT05948475 is a Phase 3 study of Cholangiocarcinoma that is actively recruiting participants, run by TransThera Sciences (Nanjing). The registered enrollment target is 200 participants, below the 383-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05948475, a Phase 3 study of Cholangiocarcinoma, is actively recruiting participants, sponsored by TransThera Sciences (Nanjing).
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma
Primary Outcome
As assessed per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 (or the most current version).
Conditions Studied
Interventions
- DRUG Tinengotinib 8 mg
- DRUG Tinengotinib 10 mg
- DRUG Physician's Choice
Study Locations (20)
California
- UCLA Medical Center - Santa Monica
- Stanford Cancer Center - Stanford
- The University of Kansas Cancer Center - Westwood, Los Angeles
Texas
- University of Texas Southwestern Medical Center - Dallas
- Texas Oncology-Sammons Cancer Center - Dallas
- The University of Texas MD Anderson Cancer Center - Houston
Michigan
- University of Michigan - Ann Arbor
- Henry Ford - Detroit
Tennessee
- Tennessee Oncology- Nashville - Nashville
- Vanderbilt-Ingram Cancer Center - Nashville
Florida
- Mount Sinai Comprehensive Cancer Center - Miami Beach
Illinois
- The University of Chicago Hospitals - Chicago
Massachusetts
- UMass Memorial Medical Center - Worcester
Minnesota
- University of Minnesota- Masonic Cancer Center, M Health Fairview - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-12-20 |
| Est. Completion | 2026-08 |
| Phase | Phase 3 |
What NCT05948475 shows while recruiting
NCT05948475 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 383-participant average among 60 other Cholangiocarcinoma trials with a reported enrollment target (48% lower).
The record links to 1 condition, with Cholangiocarcinoma appearing as the primary indexed condition, and to 3 interventions - of which Tinengotinib 8 mg is the first listed.
NCT05948475 names 20 study sites across 14 states, led by California, Texas, Michigan.
Frequently Asked Questions
What is clinical trial NCT05948475 about?
NCT05948475 is a clinical study titled "Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma". This study is a Phase III, Randomized, Controlled, Global Multicenter Study to Evaluate the Efficacy and Safety of Oral Tinengotinib versus Physician's Choice in Subjects with Fibroblast Growth Factor Receptor (FGFR)-altered, Chemotherapy- and FGFR Inhibitor-Refractory/Relapsed Cholangiocarcinoma
What is the current status of trial NCT05948475?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2023-12-20. Estimated completion is 2026-08.
What conditions does trial NCT05948475 study?
This clinical trial studies the following conditions: Cholangiocarcinoma.
What interventions are being tested in trial NCT05948475?
The interventions under investigation include: Tinengotinib 8 mg (DRUG), Tinengotinib 10 mg (DRUG), Physician's Choice (DRUG).
Who is sponsoring clinical trial NCT05948475?
This trial is sponsored by TransThera Sciences (Nanjing), which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05948475 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cholangiocarcinoma
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 NCT05948475's enrollment target sits among peer trials
200 20th of 60 higher than 40 of 60 other Cholangiocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cholangiocarcinoma 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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