← Back to Search

Monoclonal Antibodies

Emactuzumab for Giant Cell Tumor (TANGENT Trial)

Phase 3
Recruiting
Led By Jean Y Blay, Prof, MD
Research Sponsored by SynOx Therapeutics Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Biopsy-confirmed local or diffuse TGCT with predicted worsening functional limitations through surgical joint damage or high risk of early recurrence
Age >12 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

TANGENT Trial Summary

This trial is testing a new drug, emactuzumab, to see if it is effective and safe for treating patients with a type of cancer called testicular germ cell tumor (TGCT) when surgery is not an option. The trial has two parts. In the first part, subjects will be given the drug or a placebo (fake drug) intravenously (through a vein) 5 times over the course of 24 weeks. A number of tests will be done during this time to see how subjects are responding to the drug. In the second part, subjects who were given the placebo in the first part will have the option to take the drug

Who is the study for?
This trial is for individuals over 12 with TGCT where surgery could worsen joint function or has high recurrence risk, and who can't have improved outcomes from surgery. Participants need proper organ/bone marrow function, a negative pregnancy test for women of childbearing age, and must agree to use effective contraception.Check my eligibility
What is being tested?
The study tests emactuzumab's effectiveness and safety in treating TGCT when surgery isn't an option. It's a double-blind trial comparing emactuzumab with placebo given as an IV every two weeks for five sessions, followed by observation and long-term follow-up phases.See study design
What are the potential side effects?
While specific side effects are not listed here, participants will undergo regular health checks including blood tests and electrocardiograms to monitor any adverse reactions to the treatment.

TANGENT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My biopsy shows TGCT that could worsen my joint function or recur quickly.
Select...
I am older than 12 years.

TANGENT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Duration of response (DoR)
Physical Function
Quality of Life (QoL)
+4 more

TANGENT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1 in Part 1/Part 2: EmactuzumabExperimental Treatment1 Intervention
Group 1: Subjects receiving emactuzumab administered on Day(D)1 and repeated once every two weeks (Q2W) for a total of 5 times, followed by an observation period of 3 months leading to a total period of 24 weeks in Part 1 and continued with a follow-up phase in Part 2. Subjects assigned to active drug in Part 1 have the option to receive open-label retreatment under certain circumstances
Group II: Group 2 in Part 1 and Part 2: PlaceboPlacebo Group1 Intervention
Group 2: Subjects receiving placebo administered as iv infusion on D1 and repeated once every two weeks (Q2W) for 5 times followed by an observation period of 3 months to a total period of 24 weeks in Part 1 will have the option to crossover under certain circumstances to open-label emactuzumab once every 2 weeks (Q2W) for a total of 5 times in Part 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emactuzumab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

SynOx Therapeutics LimitedLead Sponsor
Jean Y Blay, Prof, MDPrincipal InvestigatorComprehensive Cancer Centre of Lyon

Media Library

Emactuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05417789 — Phase 3
Testicular Germ Cell Tumor Research Study Groups: Group 1 in Part 1/Part 2: Emactuzumab, Group 2 in Part 1 and Part 2: Placebo
Testicular Germ Cell Tumor Clinical Trial 2023: Emactuzumab Highlights & Side Effects. Trial Name: NCT05417789 — Phase 3
Emactuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05417789 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any documented dangers associated with Emactuzumab?

"Emactuzumab is a medication that has completed clinical trials and thus, has some data to support its efficacy. Additionally, because this is a Phase 3 trial, there are multiple rounds of safety data supporting its use."

Answered by AI

Are people currently being recruited for this drug trial?

"Unfortunately, at this time potential patients cannot apply to be a part of this trial. Although the most recent update on clinicaltrials.gov was on September 23rd 2022, the study is not recruiting patients currently. There are 16 other trials which are presently looking for participants however."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)
2024. "Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05417789.
~85 spots leftby Sep 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top