A Phase 2/3, Multicenter, Randomized Study of Raludotatug Deruxtecan (R-DXd), a CDH6-directed Antibody-drug Conjugate, in Subjects with Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507914-28-00

Acronym

DS6000-109

Enrollment

293

Registered

2024-05-23

Start date

2024-06-19

Completion date

Unknown

Last updated

2025-10-27

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

Conditions

Platinum-resistant, high-grade serous ovarian cancer (OVC), high-grade endometrioid OVC, primary peritoneal cancer, or fallopian tube cancer

Brief summary

Phase 2: ORR as assessed by BICR based on RECIST version 1.1 Phase 3: ORR as assessed by BICR based on RECIST version 1.1 PFS as assessed by BICR based on RECIST version 1.1 or death due to any reason

Interventions

DRUGGEMCITABINE HYDROCHLORIDE

DRUGTOPOTECAN

DRUGRaludotatug Deruxtecan

DRUGPACLITAXEL

DRUGDOXORUBICIN HYDROCHLORIDE

DRUGLIPOSOMAL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase 2: ORR as assessed by BICR based on RECIST version 1.1 Phase 3: ORR as assessed by BICR based on RECIST version 1.1 PFS as assessed by BICR based on RECIST version 1.1 or death due to any reason	—

Countries

Czechia, Finland, France, Germany, Greece, Italy, Poland, Portugal, Spain

Outcome results

None listed

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