REFRaME-O1: A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) versus Investigator’s 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

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512477-27-00

Acronym

STRO-002-GM3

Enrollment

193

Registered

2024-07-01

Start date

Unknown

Completion date

2025-03-28

Last updated

2025-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Epithelial Ovarian Cancer (including Fallopian Tube or Primary Peritoneal cancers)

Brief summary

• PFS per RECIST 1.1, • Objective response rate (ORR) per RECIST 1.1

Detailed description

• Overall survival (OS), • Duration of response (DOR) per RECIST 1.1, • Incidence and severity of AEs and clinical laboratory abnormalities per NCI CTCAE V5.0, • Change from baseline to Week 8 (for q4w) or Week 9 (for q3w) in the score for the abdominal GI symptoms subscale

Interventions

DRUGHYCAMTIN 4 mg powder for concentrate for solution for infusion

DRUGTAXOL 6 mg/ml

DRUGconcentrato per soluzione per infusione.

DRUGNeulasta 6 mg solution for injection

DRUGCaelyx pegylated liposomal 2 mg/ml concentrate for solution for infusion

DRUGGEMZAR 1000 mg

DRUGpoudre pour solution pour perfusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• PFS per RECIST 1.1, • Objective response rate (ORR) per RECIST 1.1	—

Secondary

Measure	Time frame
• Overall survival (OS), • Duration of response (DOR) per RECIST 1.1, • Incidence and severity of AEs and clinical laboratory abnormalities per NCI CTCAE V5.0, • Change from baseline to Week 8 (for q4w) or Week 9 (for q3w) in the score for the abdominal GI symptoms subscale	—

Countries

Austria, Belgium, Czechia, Finland, Germany, Hungary, Ireland, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026