Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-07 @ 9:22 PM
Study NCT ID:
NCT05924256
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2023-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
A Phase II Study of Advanced Salivary Gland Carcinoma Based on Molecular Typing
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single-center, open-label, phase 2 study to evaluate the efficacy and safety of target therapy for patients with relapsed/metastastic salivary gland carcinoma based on molecular typing.
Detailed Description:
Patients with IHC HER2 IHC 3+ or IHC 2+/ISH+ will be located into arm 1 to receive anti-her2 ADC（SHR- A1811） Patients with IHC AR positive will be located into arm 2 to receive anti-androgen therapy (SHR-3680)+leuprolide Patients with HER2 negative and AR negative will be located into arm 3 to receive anti-TROP2 ADC (SHR-A1921) Patients with IHC HER2 IHC 1+ or IHC 2+/ISH- will be located into arm 4 to receive anti-her2 ADC（SHR- A1811）
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: