Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-04-22 @ 10:04 PM
Study NCT ID:
NCT05524194
Status:
UNKNOWN
Last Update Posted:
2022-09-01
First Post:
2022-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
6MW3511 in Patients With Advanced Solid Tumor
Sponsor:
Mabwell (Shanghai) Bioscience Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase I/II, Multicenter, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Pharmacodynamics of 6MW3511 in Patients With Advanced Solid Tumor
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
NOT_YET_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:
This is a phase I/II , open-label, multicenter single arm study designed to evaluate the safety, tolerability, pharmacokinetic (PK), and immunogenicity of 6MW3511.
Detailed Description:
This is a Phase I/II, open-label, dose-escalation trial with consecutive parallel-group expansion in selected solid tumor indications. The study consists of a dose escalation phase to determine the maximum tolerated dose (MTD), or recommended Phase 2 dose (RP2D) for 6MW3511, and a dose expansion phase which will characterize treatment of 6MW3511 at the RP2D.
Study Oversight
Has Oversight DMC:
False
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?: