DS6000-109 Phase2/3 R-DXd versus Investigator’s Choice in Platinum-resistant Ovarian Cancer

• Research type

  Research Study

• Full title

  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 (Dose Optimization and Phase 3 Study of R-DXd versus Investigator’s Choice of Chemotherapy in Platinum resistant Ovarian Cancer)

• IRAS ID

  1009458

• Contact name

  Bettina Steffens

• Contact email

  TBEU-clinicaltrials@daiichi-sankyo.eu

• Sponsor organisation

  Daiichi Sankyo Inc.

• Clinicaltrials.gov Identifier

  NCT06161025

• Research summary

  This study will focus on R-DXd in participants with platinum-resistant, high-grade ovarian, primary peritoneal, or fallopian tube cancer. R-DXd is an antibody-drug conjugate that specifically binds to CDH6, which is overexpressed in tumour cells. The Phase 2 dose-optimization part of the study (Part A) intends to define the recommended dose based on safety and efficacy, while the Phase 3 (Part B) part of the study will compare R-DXd with Investigator's choice of chemotherapy and further evaluate efficacy.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  24/EM/0078

• Date of REC Opinion

  11 Jun 2024

• REC opinion

  Further Information Favourable Opinion