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NCT05417789 · ClinicalTrials.gov registry record · Phase 3
Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)
A Phase 3 study of TGCT, sponsored by SynOx Therapeutics Limited.
- Active
- Registry status
- Phase 3
- Development phase
- 128
- Enrollment target
- 20
- Study locations
NCT05417789: Active Phase 3 study of TGCT, sponsored by SynOx Therapeutics Limited.
NCT05417789 is a Phase 3 study of TGCT that is active but no longer recruiting, run by SynOx Therapeutics Limited. The registered enrollment target is 128 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05417789, a Phase 3 study of TGCT, is active but no longer recruiting, sponsored by SynOx Therapeutics Limited.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 128 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a multicenter, Phase 3, randomised, double-blind, placebo-controlled study, which aims to evaluate the efficacy and safety of the investigational drug emactuzumab for the treatment of patients with localized or diffuse TGCT where surgical removal of the tumor is not viewed as an option. The study consists of two parts. In Part 1, eligible subjects will be assigned in a 2:1 ratio to receive either emactuzumab or matching placebo in a double-blind fashion, that will be administered in total 5 times as an intravenous (i.v.) infusion once every 2 weeks. This will be followed by an observation period of 3 months leading to a total duration of 24 weeks in Part 1. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. Part 2 is a long-term double-blind follow-up phase of the subjects on emactuzumab or placebo. Subjects assigned to placebo in Part 1 have the option, subject to eligibility, to crossover to receive open-label emactuzumab in Part 2. Subjects assigned to active drug in Part 1 have the option to receive open-label retreatment under certain circumstances.
Primary Outcome
Objective Response Rate (ORR = complete response \[CR\] + partial response \[PR\]) by 6 months from initiation of therapy according to RECIST v1.1 based on independent, blinded central review
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Emactuzumab
Study Locations (20)
California
- NextGen Oncology - Beverly Hills
- Sarcoma Oncology Research Center, LLC - Los Angeles
- USC Norris Comprehensive Cancer Center - Los Angeles
Other
- LKH-Universitätsklinikum Graz - Graz
- UZ Gent - Department of Medical Oncology - Ghent
Kansas
- University of Kansas Cancer Center (Overland Park) - USOR - Overland Park
Minnesota
- University of Minnesota - Minneapolis
North Carolina
- Duke Cancer Center - Durham
Ohio
- The Ohio State University - Columbus
Oregon
- OHSU Knight Cancer Institute Hematology Oncology - Portland
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2024-10-09 |
| Est. Completion | 2027-09-30 |
| Phase | Phase 3 |
What the registry record for NCT05417789 still lists
NCT05417789 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 1 condition, with TGCT appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05417789 names 20 study sites across 17 states, led by California, Other, Kansas.
Frequently Asked Questions
What is clinical trial NCT05417789 about?
NCT05417789 is a clinical study titled "Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)". This is a multicenter, Phase 3, randomised, double-blind, placebo-controlled study, which aims to evaluate the efficacy and safety of the investigational drug emactuzumab for the treatment of patients with localized or diffuse TGCT where surgical removal of the tumor is not viewed as an option. The...
What is the current status of trial NCT05417789?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 128 participants. The study started on 2024-10-09. Estimated completion is 2027-09-30.
What conditions does trial NCT05417789 study?
This clinical trial studies the following conditions: TGCT.
What interventions are being tested in trial NCT05417789?
The interventions under investigation include: Placebo (DRUG), Emactuzumab (DRUG).
Who is sponsoring clinical trial NCT05417789?
This trial is sponsored by SynOx Therapeutics Limited, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05417789 being conducted?
This trial has 20 study locations across California, Kansas, Minnesota, North Carolina, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05417789's enrollment target sits among peer trials
128 1601st of 2000 higher than 399 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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