Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05870748
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2023-05-12
Brief Title:
REFRaME-O1 A Study to Investigate the Efficacy and Safety of Luveltamab Tazevibulin Versus Investigators Choice IC Chemotherapy in Women With Ovarian Cancer Including Fallopian Tube or Primary Peritoneal Cancers Expressing FOLR1
Sponsor:
Sutro Biopharma Inc
Organization:
Sutro Biopharma Inc
Study Overview
Official Title:
REFRaME-O1 A Phase 23 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin STRO-002 Versus Investigators Choice IC Chemotherapy in Women With Relapsed Platinum-resistant Epithelial Ovarian Cancer Including Fallopian Tube or Primary Peritoneal Cancers Expressing Folate Receptor Alpha FOLR1
Status:
RECRUITING
Status Verified Date:
2024-04
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:
A Phase 23 study to investigate the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in women with ovarian cancer including fallopian tube or primary peritoneal cancers expressing FOLR1
Detailed Description:
This is a randomized multicenter international open-label 2-part Phase 23 study designed to assess the efficacy and safety of luveltamab tazevibulin versus IC chemotherapy in subjects with relapsed platinum-resistant epithelial ovarian cancer expressing FOLR1
Part 1 will consist of 2 luveltamab tazevibulin dosing cohorts Cohort A and Cohort B with subjects randomized 11 Part 1 will be used to select the optimized dosing regimen
Part 2 will further evaluate the efficacy and safety of the selected dosing regimen versus IC chemotherapy
Luveltamab tazevibulin will be administered intravenously IV over a 1-hour infusion time every 3 weeks
Part 1 will consist of 2 luveltamab tazevibulin dosing cohorts Cohort A and Cohort B with subjects randomized 11 Part 1 will be used to select the optimized dosing regimen
Part 2 will further evaluate the efficacy and safety of the selected dosing regimen versus IC chemotherapy
Luveltamab tazevibulin will be administered intravenously IV over a 1-hour infusion time every 3 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| APGOT-OV9 | OTHER | Asia-Pacific Gynecologic Oncology Trials Group | None |
| GOG-3086 | OTHER | None | None |
| ENGOT-OV79 | OTHER | None | None |
| GEICO-134-O | OTHER | None | None |