Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06654011
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-20
Brief Title:
IN10018 with Nab-Paclitaxel and Cadonilimab for Metastatic or Recurrent Gastric-Type Cervical Adenocarcinoma Phase 2 Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
IN10018 Plus Nab-Paclitaxel and Cadonilimab for Metastatic Recurrent or Persistent Gastric-Type Adenocarcinoma of the Cervix a Multicenter Single-Arm Phase II Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gastric-type adenocarcinoma of the cervix is the most commonly diagnosed HPV-independent subtype of cervical cancer characterized by a poor prognosis and limited responsiveness to existing therapies Therefore the exploration of new treatment modalities is critically important This is an open-label single-arm multi-center clinical trial to evaluate the efficacy and safety of IN10018 plus nab-paclitaxel and cadonilimab in the treatment of adult women with metastatic recurrent or persistent gastric-type adenocarcinoma of the cervix
Detailed Description:
Subjects will receive IN10018 at a dose of 100 mg orally once daily in combination with nab-paclitaxel at 260 mgm² and cadonilimab at 10 mgkg both administered via intravenous infusion on Day 1 of each 3-week cycle Tumor assessments will be conducted every 2 cycles throughout the treatment period If the therapy proves effective chemotherapy will continue for up to 6 cycles Upon completion of chemotherapy maintenance therapy with cadonilimab and IN10018 will begin and continue until either disease progression or the emergence of intolerable toxicity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None