Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2025-12-17 @ 10:54 PM
Study NCT ID:
NCT04837508
Status:
None
Last Update Posted:
2021-12-10 00:00:00
First Post:
2021-04-06 00:00:00
Brief Title:
A Study of MRG002 in the Treatment of HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer
Sponsor:
Shanghai Miracogen Inc
Organization:
Shanghai Miracogen Inc.
Study Overview
Official Title:
An Open-label, Single-arm, Multi-center, Phase II Clinical Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable, Locally Advanced or Metastatic Biliary Tract Cancer
Status:
None
Status Verified Date:
2021-12
Last Known Status:
RECRUITING
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:
The study consists of two stages. In Phase IIa, 25-31 eligible subjects will be enrolled to evaluate the safety and preliminary efficacy of MRG002. Based on the initial safety and efficacy data obtained from the Phase IIa, the study design of the second stage Phase IIb single-arm study either will be adjusted or the trial will be stopped. If the Phase IIa data support the continuation of the study, in the second stage, approximately an additional 55 subjects will be enrolled to further evaluate the efficacy and safety of MRG002.
Detailed Description:
The study consists of two stages In Phase IIa 25-31 eligible subjects will be enrolled to evaluate the safety and preliminary efficacy of MRG002 Based on the initial safety and efficacy data obtained from the Phase IIa the study design of the second stage Phase IIb single-arm study either will be adjusted or the trial will be stopped If the Phase IIa data support the continuation of the study in the second stage approximately an additional 55 subjects will be enrolled to further evaluate the efficacy and safety of MRG002
Study Oversight
Has Oversight DMC:
None
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?:
None