Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650332
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GCGEJ Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Multicohort Phase III Study of the Cadonilimab AK104 Combination Regimen as First-line Treatment for HER2-expressing Unresectable Locally Advanced or Metastatic Gastric G or Gastroesophageal Junction GEJ Cancer
Status:
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:
This trial is An open-label multicohort multicenter clinical study aimed at evaluating the efficacy and safety of the cadonilimab combination regimen in the treatment of advanced HER-2 positive gastricgastroesophageal junction tumors
Detailed Description:
This is a phase ⅠⅡ clinicaltrial Phase I aims to determine the maximum tolerated dose MTD or if the MTD is not reached the maximum administered dose MAD of AK104 in combination with RC48 disitamab vedotin as first-line treatment for unresectable locally advanced or metastatic GCGEJ cancer as well as the recommended phase II dose RP2D
Phase II aims to evaluate the efficacy and safety of AK104 in combination with trastuzumab and chemotherapy as first-line treatment for HER2-positive unresectable locally advanced or metastatic GCGEJ cancer as well as the efficacy and safety of AK104 in combination with RC48 disitamab vedotin and chemotherapy as first-line treatment for HER2-expressing unresectable locally advanced or metastatic GCGEJ cancer
Phase II aims to evaluate the efficacy and safety of AK104 in combination with trastuzumab and chemotherapy as first-line treatment for HER2-positive unresectable locally advanced or metastatic GCGEJ cancer as well as the efficacy and safety of AK104 in combination with RC48 disitamab vedotin and chemotherapy as first-line treatment for HER2-expressing unresectable locally advanced or metastatic GCGEJ cancer
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