Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-01-01 @ 8:11 AM
Study NCT ID:
NCT05431569
Status:
UNKNOWN
Last Update Posted:
2022-06-24
First Post:
2022-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase IIa Study to Evaluate the Efficacy and Safety of 6MW3211 in Patients With Advanced Lung Cancer
Sponsor:
Mabwell (Shanghai) Bioscience Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase IIa Study to Evaluate the Efficacy and Safety of 6MW3211 in Patients With Advanced Lung Cancer Who Had Failed Therapy With PD-1/L1 Inhibitor
Status:
UNKNOWN
Status Verified Date:
2022-06
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:
A non-randomized, open, Simon'soptimal2-stage study to evaluate the efficacy and safety of 6MW3211 in patients with advanced Lung Cancer who had failed therapy with PD-1/L1 Inhibitor.
Detailed Description:
36 to 64 patients with advanced lung cancer who failed pD-1 /L1 inhibitor treatment will be inrolled.
Cohort 1:20 to 33 patients with non-small cell lung cancer (NSCLC) Cohort 2:16 to 31 patients with small cell lung cancer (SCLC)
Cohort 1:20 to 33 patients with non-small cell lung cancer (NSCLC) Cohort 2:16 to 31 patients with small cell lung cancer (SCLC)
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?: