Ignite Creation Date:
2024-05-06 @ 3:01 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04492488
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-05-06
First Post:
2020-07-23
Brief Title:
A Study of MRG002 in Patients with HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic GastricGastroesophageal Junction GEJ Cancer
Sponsor:
Shanghai Miracogen Inc
Organization:
Shanghai Miracogen Inc
Study Overview
Official Title:
An Open-Label Multi-center Phase III Dose Escalation and Expansion Study to Assess the Safety Efficacy and Pharmacokinetics of MRG002 in Patients with HER2-Positive Advanced Solid Tumors and Locally Advanced or Metastatic GastricGastroesophageal Junction GEJ Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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 objective of this study is to assess the safety efficacy and pharmacokinetics of MRG002 as well as the immunogenicity as defined by the incidence of anti-drug antibody ADA of MRG002 in patients with HER2-positive advanced solid tumors and locally advanced or metastatic gastricgastroesophageal junction GEJ cancer
Detailed Description:
This study consists of two parts In Part A patients will receive MRG002 as a monotherapy at doses of 22 or 26 mgkg intravenously IV over 60-90 minute on Day 1 of every 3 weeks Q3W to determine the maximum tolerated dose MTD and recommended phase II dose RP2D In part B patients will receive a single IV infusion of MRG002 at RP2D on Day 1 of Q3W
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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