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New treatment option for Salivary Gland Carcinoma
Official title Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing
ClinicalTrials.gov ID: NCT06145308
What this study is testing
What is Cohort 1 (HER2-positive, RC48-ADC)?
Cohort 1 (HER2-positive, RC48-ADC) is an investigational medicine, being studied as a potential treatment for salivary gland carcinoma.
Also referred to as HER2,Vedolizumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Patients with salivary gland carcinoma were divided into groups according to HER2, NTRK, AR, TROP-2, etc. Patients in different groups were given precision targeted therapy or chemotherapy to evaluate the efficacy (ORR rate) and safety of precision therapy.
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- Patients with histopathologic diagnosis of salivary gland carcinoma
- The tumor tissues were subjected to HER2/NTRK/AR/TROP-2 immunohistochemical staining.
- ECOG physical status 0 or 1 score in the 3 days before the first medication of the study treatment;
- Age 18 or older - no upper limit;
- Life expectancy is more than 3 months; ⑥Have at least one measurable lesion according to RECIST1.1 standards; ⑦Women of childbearing age must have a...
You likely can't join if
- Known hypersensitivity or delayed anaphylaxis to any agents in this trial;
- Major surgery had been performed within 4 weeks prior to the start of the study and did not fully recover;
- Have received a live vaccine within 4 weeks before the start of the study or plan to receive any vaccine during the study period ;
- To study the occurrence of arterial/venous thrombosis events within 6 months before medication;
- Major cardiovascular diseases;
- Is suffering from uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung...
See the full eligibility criteria
- Patients with histopathologic diagnosis of salivary gland carcinoma
- The tumor tissues were subjected to HER2/NTRK/AR/TROP-2 immunohistochemical staining.
- ECOG physical status 0 or 1 score in the 3 days before the first medication of the study treatment;
- Age 18 or older - no upper limit;
- Life expectancy is more than 3 months; ⑥Have at least one measurable lesion according to RECIST1.1 standards; ⑦Women of childbearing age must have a negative pregnancy test within 7 days before the first medication, and...
- Known hypersensitivity or delayed anaphylaxis to any agents in this trial;
- Major surgery had been performed within 4 weeks prior to the start of the study and did not fully recover;
- Have received a live vaccine within 4 weeks before the start of the study or plan to receive any vaccine during the study period ;
- To study the occurrence of arterial/venous thrombosis events within 6 months before medication;
- Major cardiovascular diseases;
- Is suffering from uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, cirrhosis, etc.;
- Is suffering from an active infection that requires systemic treatment;
- History of active tuberculosis; ⑨ Positive human immunodeficiency virus (HIV) test result; ⑩ Patients with chronic hepatitis B or active hepatitis C. ⑪Conditions that the investigator believes will affect the safety or...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.