Phase
Condition
Ovarian Cysts
Treatment
Raludotatug Deruxtecan
Bevacizumab
Carboplatin
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Has pathologically documented diagnosis of high-grade serous epithelial ovariancancer, 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 1 and Arm 2: Has relapsed disease after 1 to 3 priorlines of therapy and radiographic evidence of disease progression ≥6 months (≥180days) after the last dose of platinum-based therapy (ie, platinum-sensitivedisease).
Participants in Cohort B-1: Has relapsed disease after 1 to 3 prior lines of therapyand radiographic evidence of disease progression <6 months (<180 days) after thelast dose of platinum-based therapy (ie, platinum-resistant disease).
Participants in Cohort B-1: Is a candidate for bevacizumab treatment
Has provided tumor tissue from a core or excisional biopsy of a tumor lesion notpreviously irradiated
Has an Eastern Cooperative Oncology Group performance status of 0 to 1 assessedwithin 7 days before allocation
Human immunodeficiency virus (HIV)-infected participants must have well controlledHIV on anti-retroviral therapy
Participants who are hepatitis B surface antigen positive are eligible if they havereceived hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and haveundetectable HBV viral load prior to allocation
Participants with a history of hepatitis C virus (HCV) infection are eligible if HCVviral load is undetectable at screening
Exclusion
Exclusion Criteria:
Has any of the following within 6 months before allocation: cerebrovascularaccident, transient ischemic attack, or other arterial thromboembolic event
Has uncontrolled or significant cardiovascular disease
Has clinically severe pulmonary compromise resulting from intercurrent pulmonaryillnesses including, but not limited to, any underlying pulmonary disorder, and anyautoimmune, connective tissue, or inflammatory disorders with potential pulmonaryinvolvement, 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 agentswithin 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 treatmentwithin the past 3 years
Has known active CNS metastases and/or carcinomatous meningitis
Has history of (noninfectious) pneumonitis/interstitial lung disease (ILD) thatrequired steroids or has current pneumonitis/ILD
Has active infection requiring systemic therapy
HIV-infected participants with a history of Kaposi's sarcoma and/or MulticentricCastleman's Disease
Study Design
Connect with a study center
Rambam Health Care Campus ( Site 0202)
Haifa, 3109601
IsraelActive - Recruiting
Shaare Zedek Medical Center ( Site 0201)
Jerusalem, 9103102
IsraelActive - Recruiting
Sheba Medical Center ( Site 0200)
Ramat Gan, 5265601
IsraelActive - Recruiting
START Mountain Region ( Site 0008)
West Valley City, Utah 84119
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.