Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04900519
Status:
RECRUITING
Last Update Posted:
2023-01-17
First Post:
2021-05-17
Brief Title:
Study of the Safety and Efficacy of STI-6643 in Subjects With Advanced Solid Tumors
Sponsor:
Sorrento Therapeutics Inc
Organization:
Sorrento Therapeutics Inc
Study Overview
Official Title:
A Phase 1 Open-Label Dose-Escalation Study of the Safety and Efficacy of STI-6643 an Anti-CD47 Human Monoclonal Antibody in Subjects With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-01
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:
This is a first-in-human phase 1 open-label dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsedrefractory advanced solid tumor
Detailed Description:
This is a first-in-human phase 1 open-label dose-escalation study of STI-6643 administered by intravenous infusion in subjects with a relapsedrefractory advanced solid tumor
The study will determine an MTD and RP2D using a conventional 33 study design with priming dose identification PDI stage and therapeutic dose TD escalation TDE stage Dose limiting toxicity evaluated over the initial 28 days of STI-6643 administration
The study will determine an MTD and RP2D using a conventional 33 study design with priming dose identification PDI stage and therapeutic dose TD escalation TDE stage Dose limiting toxicity evaluated over the initial 28 days of STI-6643 administration
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