NCT06161025PHASE2, PHASE3RECRUITING3 endpoints open for prediction

A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

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

Sponsor: Daiichi Sankyo + Merck Sharp & Dohme LLC

Open for Predictions · 3 endpoints

NCT06161025Objective Response Rate (ORR %)Primary

The percentage of patients with confirmed complete or partial response per RECIST 1.1. Higher is better.

Prediction range: 0 – 100 %

NCT06161025Hazard Ratio for Progression-Free Survival (PFS)Primary

A Hazard Ratio below 1.0 favours the treatment arm. HR 0.65 means a 35% reduction in the risk of progression or death.

Prediction range: 0.3 – 1.1 Hazard Ratio

NCT06161025Hazard Ratio for Overall Survival (OS)

A Hazard Ratio below 1.0 favours the treatment arm. HR 0.75 means a 25% reduction in the risk of death.

Prediction range: 0.4 – 1.2 Hazard Ratio

Key Facts

Study type

INTERVENTIONAL

Conditions

Solid Cancer

Interventions

R-DXd, Paclitaxel, Topotecan, PLD

Enrollment

860 participants

Primary completion

Feb 2028

Study completion

Apr 2030

First posted

Dec 2023

Last updated

May 2026

Primary Endpoints (CT.gov)

Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) Assessment (Part A)

Time frame: From date of randomization to data cut off, up to 18 months

Progression-free Survival (PFS) Based on BICR Assessment (Part B)

Time frame: From date of randomization to data cut off, up to 26 months

Secondary Endpoints

Objective Response Rate (ORR) Based on Investigator Assessment

Overall Survival (OS)

Duration of Response (DOR)

Eligibility Criteria

Inclusion Criteria: * Sign and date the informed consent form prior to the start of any study-specific qualification procedures. * Age ≥18 years or the minimum legal adult age (whichever is greater) at the time the informed consent form is signed. * Participants with histologically or cytologically documented high-grade serous ovarian cancer (OVC), high-grade endometrioid OVC, primary peritoneal cancer, or fallopian tube cancer. * For Phase 2 (Part A) Participants must have at least 1 lesion, not previously irradiated, amenable to biopsy, and must consent to provide a pretreatment biopsy and on-treatment biopsy tissue sample (on-treatment biopsy sample not required for the Phase 3 part of the study). Fresh pretreatment biopsy may be waived for subjects who consent to provide an archival tumor tissue sample from a lesion not previously irradiated, performed within 6 months of consent and performed after treatment with their most recent cancer therapy regimen. * For Phase 2 (Part A): Ha…

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov

Related Program

R-DXd

Daiichi Sankyo

View program page →