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OncoMatch/Clinical Trials/NCT06161025

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

Is NCT06161025 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including R-DXd and Paclitaxel for solid cancer.

Phase 2/3RecruitingDaiichi SankyoNCT06161025Data as of May 2026

Treatment: R-DXd · Paclitaxel · Topotecan · PLDThis study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.

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Extracted eligibility criteria

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 3 prior lines
Min 1 prior line

Must have received: bevacizumab-containing therapy (bevacizumab) — at least 1 line

At least 1 line of therapy containing bevacizumab, unless the subject is not eligible for treatment with bevacizumab due to precautions/intolerance.

Must have received: systemic anticancer therapy — at least 1 but no more than 3 prior systemic lines of anticancer therapy

Has received at least 1 but no more than 3 prior systemic lines of anticancer therapy. Subjects must have progressed radiologically on or after their most recent line of systemic therapy.

Must have received: platinum-based chemotherapy — platinum-resistant disease

Has platinum-resistant disease. If a subject had only 1 line of platinum therapy, must have received at least 4 cycles of platinum, must have had a best response of not PD, and then progressed between >90 and ≤180 days after the date of the last dose of platinum. If a subject had 2 or 4 lines of platinum therapy, must have received at least 2 cycles of platinum and have progressed on or within 180 days after the date of the last dose of platinum.

Must have received: mirvetuximab soravtansine (mirvetuximab soravtansine) — if locally available and high-folate receptor alpha expression

Has had prior treatment with MIRV for participants with documented high-folate receptor alpha expression, unless the participant is not eligible for treatment with mirvetuximab soravtansine due to precautions/intolerance, or if the treatment is not approved or available locally.

Cannot have received: CDH6-targeted agent

Prior exposure to other CDH6-targeted agents

Cannot have received: antibody-drug conjugate containing a topoisomerase I inhibitor (trastuzumab deruxtecan, datopotamab deruxtecan)

Prior exposure to an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan or datopotamab deruxtecan). For Phase 3 (Part B): Prior exposure to other CDH6-targeted agents or an antibody-drug conjugate containing a topoisomerase I inhibitor.

Lab requirements

Blood counts

adequate organ and bone marrow function as assessed by local laboratory (within 14 days before start of study drug administration)

Kidney function

adequate organ and bone marrow function as assessed by local laboratory (within 14 days before start of study drug administration)

Liver function

Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST/ALT <3 × ULN, which are not attributable to HCV infection.

Cardiac function

QTcF >470 ms, diagnosed or suspected long QT syndrome, history of clinically relevant ventricular arrhythmias, bradycardia <50 bpm unless pacemaker, history of second- or third-degree heart block, myocardial infarction within 6 months, uncontrolled angina within 6 months, NYHA Class 3 or 4 CHF, LVEF <50% or institutional lower limit of normal, coronary/peripheral artery bypass graft within 6 months, uncontrolled hypertension (CTCAE Grade ≥3), complete left or right bundle branch block

Has adequate organ and bone marrow function as assessed by local laboratory (within 14 days before start of study drug administration). Cardiac exclusion criteria: see protocol.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Alaska Women's Cancer Care · Anchorage, Alaska
  • Yale University School of Medicine · New Haven, Connecticut
  • Sylvester Comprehensive Cancer Center at Lennar · Coral Gables, Florida
  • Sylvester Comprehensive Cancer Center at Deerfield Beach · Deerfield Beach, Florida
  • Florida Cancer Specialists · Lake Mary, Florida

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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