Actively Recruiting
A Phase 23 Randomized Study of Raludotatug Deruxtecan R-DXd in Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Led by Daiichi Sankyo · Updated on 2026-05-22
860
Participants Needed
146
Research Sites
113 weeks
Total Duration
On this page
Sponsors
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Daiichi Sankyo
Lead Sponsor
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Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Raludotatug Deruxtecan R-DXd in people with platinum-resistant, high-grade ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. This study includes both Phase 2 and Phase 3 parts, aiming to determine the best dose of R-DXd and compare it with standard chemotherapy treatments. R-DXd is designed to target CDH6, a protein found in high amounts on tumor cells, to deliver its treatment directly to the cancer. Participants will be randomly assigned to receive intravenous R-DXd at different doses every three weeks or to receive chemotherapy chosen by the doctor, including paclitaxel, pegylated liposomal doxorubicin PLD, or topotecan. The Phase 2 part focuses on finding the recommended dose based on safety and response, while Phase 3 compares R-DXd at the recommended dose against chemotherapy to further assess its effects. Throughout the study, participants will undergo scans to measure tumor response and various assessments to monitor symptoms, side effects, and other health factors. Researchers will track outcomes like tumor shrinkage, survival without disease progression, overall survival, treatment side effects, and quality of life measures for up to 40 months. Participants will have regular visits for treatment, lab tests, and symptom evaluations to ensure close monitoring during the trial.
CONDITIONS
Brief Title
A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Histologically or cytologically confirmed high-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- For Phase 2: At least 1 lesion suitable for biopsy and willing to provide tissue samples (pretreatment and on-treatment biopsies)
- For Phase 3: Eligible for investigator's choice of chemotherapy
- Received 1 to 3 prior systemic anticancer therapies for Phase 2; 1 to 4 for Phase 3
- At least 1 prior therapy containing bevacizumab unless not eligible
- Platinum-resistant disease as defined by progression within specified time after platinum therapy
- At least 1 measurable lesion by CT or MRI per RECIST v1.1
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate organ and bone marrow function based on lab tests
- Willing and able to comply with study visits, drug administration, tests, and procedures
You will not qualify if you...
- Clear cell, mucinous, sarcomatous, mixed histology tumors, or low-grade/borderline ovarian cancer
- Inadequate washout period from prior surgery, radiation, anticancer therapy, or investigational drugs
- Active or symptomatic brain metastases or spinal cord compression requiring treatment
- Cerebrovascular events or arterial thromboembolism within past 6 months
- Significant uncontrolled cardiovascular disease including long QT syndrome, arrhythmias, recent myocardial infarction, heart failure class 3 or 4, or uncontrolled hypertension
- History or current interstitial lung disease or pneumonitis requiring corticosteroids
- Severe pulmonary compromise or prior pneumonectomy
- Chronic steroid treatment above 10 mg/day except certain exceptions
- History of other malignancies within 3 years except low-risk treated cancers
- Unresolved toxicities from prior anticancer therapy beyond grade 1 except stable grade 2 toxicities
- Prior exposure to other CDH6-targeted agents or related antibody-drug conjugates
- Hypersensitivity to study drugs or excipients
- Active or uncontrolled HIV, hepatitis B or C infections
- Pregnant or breastfeeding females
- Psychological, social, or geographic factors preventing follow-up
- Prior live-attenuated vaccine within 30 days
- For Phase 3 only: Intestinal obstruction or frequent ascites/pleural drainage needed
Research Team
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Medical Director Contact for Clinical Trial Information
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