Ignite Creation Date:
2024-05-06 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05242146
Status:
TERMINATED
Last Update Posted:
2023-06-13
First Post:
2022-01-31
Brief Title:
GB5121 in Adult Patients With RelapsedRefractory CNS Lymphoma
Sponsor:
GB005 Inc a wholly owned subsidiary of Gossamer Bio Inc
Organization:
Gossamer Bio Inc
Study Overview
Official Title:
A Phase 1b2 Open-label Dose Escalation With Expansion Study of GB5121 in Adult Patients With RelapsedRefractory Primary or Secondary Central Nervous System Lymphoma or Primary Vitreoretinal Lymphoma With a Phase 2 Open-label Single Dose Level Study of GB5121 in Adult Patients With Relapsed Refractory Primary Central Nervous System Lymphoma
Status:
TERMINATED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STAR CNS
Brief Summary:
The STAR CNS trial is a 3-part study comprising a phase 1b dose escalation dose expansion and a phase 2 to assess the safety tolerability dose-limiting toxicityies maximum tolerated dose andor optimal biological dose determine the recommended phase 2 dose preliminary anti-tumor activity and efficacy of the recommended phase 2 dose of GB5121
Detailed Description:
Note The Phase 1b dose expansion and Phase 2 parts of the study were not initiated
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