Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06008379
Status:
RECRUITING
Last Update Posted:
2023-09-13
First Post:
2023-08-07
Brief Title:
A Study of 7MW3711 in Subjects With Advanced Solid Tumors
Sponsor:
Mabwell Shanghai Bioscience Co Ltd
Organization:
Mabwell Shanghai Bioscience Co Ltd
Study Overview
Official Title:
A Phase 12 Dose Escalation and Expansion Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of 7MW3711 in Subjects With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-09
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:
7MW3711 is a antibody-drug conjugateADC drected to a target wildly expressed on solid tumors This is an open-label multicenter phase 12 study to evaluate the Safety Tolerability Pharmacokinetics and Efficacy of 7MW3711 in subjects with advanced solid tumors
Detailed Description:
Two parts are included in this study The part of dose escalation and dose expansionpart 1 will enrolled subjects with advanced solid tumors and is to evaluate the safety and tolerability and to determine the maximum tolerated dose andor the recommend pahse 2 doseRP2D of 7MW3711 in subjects with advanced solid tumors
The part of cohort expansionpart 2 will enrolled subejcts with selected advanced solid tumors and is to assess the preliminary efficacy of 7MW3711 in selected advanced solid tumors
The part of cohort expansionpart 2 will enrolled subejcts with selected advanced solid tumors and is to assess the preliminary efficacy of 7MW3711 in selected advanced solid tumors
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