Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480240
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-18
Brief Title:
A Phase 12 Study of OBI-992 in Subjects With Advanced Solid Tumors
Sponsor:
OBI Pharma Inc
Organization:
OBI Pharma Inc
Study Overview
Official Title:
A Phase 12 Open-Label Dose-Escalation and Cohort-Expansion Study Evaluating the Safety Pharmacokinetics and Therapeutic Activity of OBI-992 in Subjects With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-06
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 2-part trial Part A Dose Escalation is designed to establish the maximum tolerated dose MTD and recommended phase 2 dose RP2D of OBI-992 Anti-TROP2 antibody drug conjugate anti-TROP2 monoclonal antibody-cleavable peptide linker-exatecan as monotherapy Part B Cohort Expansion is intended to further characterize the safety and preliminary clinical activity profile of the RP2D of OBI-992 in subjects with advanced solid tumors
Detailed Description:
None
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