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Official title A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
ClinicalTrials.gov ID: NCT06161025
What this study is testing
What is R-DXd?
R-DXd is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid cancer.
Also referred to as DS-6000a.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- For Phase 2 (Part A) Participants must have at least 1 lesion, not previously irradiated, amenable to biopsy, and must consent to provide a...
- For Phase 2 (Part A): Has received at least 1 but no more than 3 prior systemic lines of anticancer therapy. For Phase 3 (Part B): Has received at...
You likely can't join if
- Has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline OVC. (Note for Phase 3 [Part B]...
- Inadequate washout period before Cycle 1 Day 1, defined as follows:
- Major surgery \<28 days
- Radiation therapy \<28 days (if palliative stereotactic radiation therapy without abdominal radiation, ≤14 days)
- Systemic anticancer therapy (including antibody-drug therapy, retinoid therapy, and hormonal therapy) \<28 days or 5 half-lives, whichever is...
- Chloroquine/hydroxychloroquine \<14 days
See the full eligibility criteria
Who can join
- 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...
- For Phase 2 (Part A): Has received at least 1 but no more than 3 prior systemic lines of anticancer therapy. For Phase 3 (Part B): Has received at least 1 but no more than 4 prior systemic lines of anticancer therapy:
- Neoadjuvant +/-adjuvant considered 1 line of therapy.
- Maintenance therapy (eg, bevacizumab, poly-ADP ribose polymerase [PARP] inhibitors) will be considered part of the preceding line of therapy.
- Therapy changed due to toxicity in the absence of progression will be considered part of the same line.
- Hormonal therapy will be counted as a separate line of therapy, unless it was given as maintenance.
- At least 1 line of therapy containing bevacizumab, unless the subject is not eligible for treatment with bevacizumab due to precautions/intolerance. Note: people must have progressed radiologically on or after their...
- 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...
- If mirvetuximab soravtansine (MIRV) is locally available: Has had prior treatment with MIRV for participants with documented high-folate receptor alpha expression, unless the participant is not eligible for treatment...
- Has at least 1 measurable lesion evaluated by computed tomography or magnetic resonance imaging according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per investigator assessment.
- Eastern Cooperative Oncology Group performance status of 0 or 1.
- Has adequate organ and bone marrow function as assessed by local laboratory (within 14 days before start of study drug administration).
- Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures and study restrictions.
- For Phase 3 (Part B) only: people must be eligible for one of the treatments included in the investigator's choice of chemotherapy arm.
What rules you out
- Has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline OVC. (Note for Phase 3 [Part B]: seromucinous, low-grade serous carcinoma or ovarian sarcoma...
- Inadequate washout period before Cycle 1 Day 1, defined as follows:
- Major surgery \<28 days
- Radiation therapy \<28 days (if palliative stereotactic radiation therapy without abdominal radiation, ≤14 days)
- Systemic anticancer therapy (including antibody-drug therapy, retinoid therapy, and hormonal therapy) \<28 days or 5 half-lives, whichever is shorter, before starting study drug
- Chloroquine/hydroxychloroquine \<14 days
- Exposure to another investigational drug within 28 days prior to start of study treatment or current participation in other therapeutic investigational procedures
- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms...
- Any of the following within the past 6 months prior to randomization: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
- Uncontrolled or significant cardiovascular disease, including the following:
- QT interval corrected with Fridericia's formula interval \>470 ms.
- Diagnosed or suspected long QT syndrome.
- History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes.
- The participant has bradycardia of less than 50 bpm, unless the subject has a pacemaker.
- History of second- or third-degree heart block. Candidates with a history of heart block may be eligible if they currently have pacemakers and have no history of fainting or clinically relevant arrhythmia with...
- Myocardial infarction within 6 months prior to screening.
- Uncontrolled angina pectoris within 6 months prior to screening.
- New York Heart Association Class 3 or 4 congestive heart failure.
- Left ventricular ejection fraction \<50% or institutional lower limit of normal as measured by echocardiography or multigated acquisition (MUGA) scan.
- Coronary/peripheral artery bypass graft within 6 months prior to screening
- Uncontrolled hypertension (HgCTCAE Grade ≥3 hypertension as per NCI-CTCAE version 5.0).
- Complete left or right bundle branch block.
- Has a history of (noninfectious) ILD/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study enrollment...
- Chronic steroid treatment (\>10 mg/day), with the exception of the following:
- Inhaled steroids for asthma or COPD
- Mineralocorticoids (eg, fludrocortisone) for people with orthostatic hypotension
- Topical steroids for mild skin conditions
- Low-dose supplemental corticosteroids for adrenocortical insufficiency
- Premedication for treatment groups and/or premedication in case of any hypersensitivity
- Intra-articular steroid injections
- History of malignancy other than epithelial OVC, primary peritoneal cancer, or fallopian tube cancer within 3 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death (eg...
- Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE Version 5.0, Grade ≤1 or baseline. Note: people may be enrolled with chronic, stable...
- Chemotherapy-induced neuropathy
- Fatigue
- Endocrinopathies, which may include hypothyroidism, hyperthyroidism, Type 1 diabetes, hyperglycemia, and adrenal insufficiency
- Skin pigmentation (vitiligo)
- For Phase 2 (Part A): Prior exposure to other CDH6-targeted agents or an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan or datopotamab deruxtecan). For Phase...
- History of hypersensitivity to any excipients in the R-DXd or any known contraindication to treatment with, including hypersensitivity to, the study drug(s).
- Has an active or uncontrolled human immunodeficiency virus (HIV) infection.
- Has any evidence of severe or uncontrolled systemic diseases (including active bleeding diatheses or active infection, substance abuse) or other factors that, in the investigator's opinion, makes it undesirable for the...
- Has an active or uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Hepatitis B and Hepatitis C Screening tests are required. people are eligible if:
- Hepatitis B virus surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
- History of hepatitis C infection: eligible if the HCV viral load is below the level of detection in the absence of antiviral therapy during the previous 4 weeks.
- 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.
- Female who is pregnant or breastfeeding or intends to become pregnant during the study.
- Psychological, social, familial, or geographical factors that would prevent regular follow-up.
- Prior or ongoing clinically relevant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the subject; alter the...
- Has a history of receiving live-attenuated vaccine (messenger RNA [mRNA] and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study...
- For Phase 3 (Part B) only: Has clinical symptoms or radiographic evidence of intestinal obstruction.
- For Phase 3 (Part B) only: Has ascites or pleural effusions that require repeated drainage (less than 4 weeks between drainages).
The study team makes the final eligibility decision.
Where it's taking place
- Anchorage, Alaska, United States
- New Haven, Connecticut, United States
- Coral Gables, Florida, United States
- Deerfield Beach, Florida, United States
- Lake Mary, Florida, United States
- Miami, Florida, United States
- Miami Beach, Florida, United States
- Plantation, Florida, United States
- Indianapolis, Indiana, United States
- Edgewood, Kentucky, United States
- Springfield, Massachusetts, United States
- St Louis, Missouri, United States
- Paramus, New Jersey, United States
- Teaneck, New Jersey, United States
- Bay Shore, New York, United States
- Lake Success, New York, United States
- Mineola, New York, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Hilliard, Ohio, United States
+ 103 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anchorage, Alaska, United States; New Haven, Connecticut, United States; Coral Gables, Florida, United States; Deerfield Beach, Florida, United States; Lake Mary, Florida, United States; Miami, Florida, United States and 117 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.