Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545617
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
A Clinical Study to Observe How Well That BAT8006 Works on Patients With Platinum Resistance Ovarian Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1b2 Multicenter Open-Label Study of BAT8006 an Anti- FRĪ± Antibody Drug Conjugate ADC for Platinum-resistant Ovarian Cancer Subjects
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 1b2 open-label 2-part global study designed to investigate the anti-tumor activity as well as the safety and efficacy of BAT8006 in subjects with platinum resistance ovarian cancer
Detailed Description:
Part 1 is a Dose Finding Study The RP2D will be confirmed in Part 1 and this RP2D will be further evaluated in Part 2 In Part 1 PK samples will be collected and analyzed to support the determination of RP2D Three dose cohorts are planned Subjects will be assigned to these three dosages in parallel
Part 2 will expose subjects at the RP2D confirmed in Part 1
Part 2 will expose subjects at the RP2D confirmed in Part 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None