Clinical Trials - DataSource by Daiichi Sankyo

A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003)

Researchers are looking for other ways to treat relapsed high-grade serous ovarian cancer. Relapsed means the cancer came back after treatment. High-grade means the cancer cells grow and spread quickly. Serous means the cancer started in the cells that cover the ovaries, the lining of the belly, or in the fallopian tubes. Standard treatment (usual treatment) for people with relapsed high-grade serous ovarian cancer may include: * Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing * Targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread Raludotatug deruxtecan (R-DXd) is a study treatment that is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to know if R-DXd is safe to take with other treatments and if people tolerate them together. They also want to learn how many people have the cancer respond (gets smaller or goes away) to the treatments.

CONDITIONS

Ovarian Cancer Recurrent

PRODUCT

R-DXd

GENDER

FEMALE

AGE

18 Years

SPONSOR

Merck Sharp & Dohme LLC

COLLABORATOR

Daiichi Sankyo

TRIAL RUNS IN

16 Global Locations

Trial Summary

This study has 2 parts: Part 1 is a dose escalation phase of R-DXd. Part 2 is the efficacy expansion phase and will use the Recommended Phase 2 Dose (RP2D) of R-DXd determined in Part 1.

A Phase 1b/2 Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan With or Without Other Anticancer Investigational Agents in Participants With High-grade Serous Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Have Relapsed After Prior Platinum-based Chemotherapy

Has pathologically documented diagnosis of high-grade serous epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
Has measurable disease per Response Evaluation Criteria In Solid Tumors 1.1
Participants in Cohort A-1 Arm 2 and Arm 3: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease).
Participants in Cohort B-1 and Cohort B-2: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression <6 months (<180 days) after the last dose of platinum-based therapy (ie, platinum-resistant disease).
Participants in Cohort B-1 and Cohort B-2: Is a candidate for bevacizumab treatment
Has provided tumor tissue from a core or excisional biopsy of a tumor lesion not previously irradiated
Has an Eastern Cooperative Oncology Group performance status of 0 to 1 assessed within 7 days before allocation
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy
Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation
Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
Participants in Cohort C-1 and Cohort D: Has relapsed disease after 1 prior line of therapy, radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease) and progressed during prior treatment with PARPi in the first-line setting

Has any of the following within 6 months before allocation: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event
Has uncontrolled or significant cardiovascular disease
Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement, or prior pneumonectomy
Has ≥Grade 2 peripheral neuropathy
Has received prior treatment with cadherin-6-targeted agents
Has received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before allocation
Has received prior radiotherapy within 2 weeks of the start of study intervention, or has radiation-related toxicities, requiring corticosteroids
Receives chronic steroid treatment
Has known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known active CNS metastases and/or carcinomatous meningitis
Has history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD
Has active infection requiring systemic therapy
HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease

This was last updated on 2025-11-06 19:34:20.426.

The content contained is taken is taken directly from public registry ClinicalTrials.gov and has not been edited.

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