Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384807
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-04-22
Brief Title:
A Phase 12 Study of BHV-1510 Previously PBI-410 in Advanced Solid Tumors
Sponsor:
Biohaven Therapeutics Ltd
Organization:
Biohaven Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 12 First in Human Dose Escalation and Dose Expansion Study of BHV-1510 Previously PBI-410 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-10
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 Phase 12 first in human FIH open-label multicenter study of PBI-410 monotherapy and PBI-410 in Combination with Cemiplimab in participants with previously treated advanced solid tumors
Detailed Description:
This is a Phase 12 first in human FIH open-label multicenter study of PBI-410 a Trop-2 directed antibody-drug conjugate ADC in participants with previously treated advanced solid tumors The study comprises 2 parts a Phase 1 Dose Escalation and a Phase 2 Dose Expansion The Phase 1 will investigate the safety and tolerability of PBI-410 given in monotherapy and given in combination with cemiplimab and identify one or more recommended doses for expansion RDEs and the maximum-tolerated dose MTD if one exists Once the RDE has been established Phase 2 will open to investigate the preliminary efficacy of PBI-410 in signal-finding expansion cohorts
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