J5E-MC-JZXB - FRAmework-01: A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan plus Bevacizumab versus Platinum-Based Chemotherapy plus Bevacizumab in Platinum-Sensitive Ovarian Cancer

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522255-25-00

Enrollment

234

Registered

2026-05-11

Start date

Unknown

Completion date

Unknown

Last updated

2026-05-12

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

Conditions

Fallopian Tube Neoplasms, Neoplasm Metastasis, Ovarian Neoplasms, Peritoneal Neoplasms

Brief summary

• Part A: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator • Part B: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded, independent, central review (BICR)

Interventions

DRUGGEMCITABINE

DRUGCARBOPLATIN

DRUGMIRVETUXIMAB SORAVTANSINE

DRUGTOPOTECAN

DRUGLY4170156

DRUGBEVACIZUMAB

DRUGPACLITAXEL

DRUGDOXORUBICIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
• Part A: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator • Part B: Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded, independent, central review (BICR)	—

Outcome results

None listed

Source: EU CTIS · Data processed: May 13, 2026