RECRUITING

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

Conditions

Solid Cancer Primary pertioneal cancer Ovarian cancer Fallopian tube cancer Raludotatug Deruxtecan (R-DXd)Cadherin 6 (CDH6)

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.

Official Title

A Phase 2/3, Multicenter, Randomized Study of Raludotatug Deruxtecan (R-DXd), a CDH6-directed Antibody-drug Conjugate, in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Quick Facts

Study Start:2024-02-27

Study Completion:2029-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06161025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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 sample not required for the Phase 3 part of the study). Fresh pretreatment biopsy may be waived for subjects who consent to provide an archival tumor tissue sample from a lesion not previously irradiated, performed within 6 months of consent, and performed after treatment with their most recent cancer therapy regimen. * Has received at least 1 but no more than 3 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: Subjects must have progressed radiologically on or after their most recent line of systemic therapy. Biochemical progression will not be considered progression for this study. * 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 3 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. * Has had prior poly-ADP ribose polymerase (PARP) inhibitors for participants with documented breast cancer gene mutation (germline and/or somatic), unless the participant is not eligible for treatment with a PARP inhibitor. * Has had prior treatment with mirvetuximab soravtansine 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. * 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. * Required baseline local laboratory data (within 7 days before start of study drug administration): * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) * 3.0 × upper limit of normal (ULN) in subjects with no liver metastasis and * 5.0 × ULN in subjects with liver metastasis * Total bilirubin (TBL) ≤1.5 × ULN (\<3 × ULN for subjects with Gilbert's syndrome or liver metastasis at baseline) * Absolute neutrophil count ≥1.5 × 109/L (growth factor support allowed up to 14 days before laboratory assessment for eligibility) * Platelet count ≥100 × 109/L (transfusion allowed up to 14 days before laboratory assessment for eligibility) * Hemoglobin ≥9.0 g/dL (transfusion and/or growth factor support allowed up to 14 days before laboratory assessment for eligibility) * Creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation * Serum albumin ≥2.5 g/dL * Adequate blood clotting function: International normalized ratio and either activated partial thromboplastin time or partial thromboplastin time ≤1.5 × ULN, unless the subject is receiving anticoagulant therapy as long as activated partial thromboplastin time or partial thromboplastin time is within the therapeutic range of intended use of anticoagulants * If the participant is a female of childbearing potential, she must have a negative serum pregnancy test at 72 hours before the first dose of study drug and must be willing to use highly effective birth control upon enrollment, during the Treatment Period, and for 7 months following the last dose of study drug. A female is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) with surgery at least 1 month before the first dose or confirmed by follicle-stimulating hormone test. * Female participants must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final 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: Participants must be eligible for one of the treatments included in the Investigator's choice of chemotherapy arm and must not have received it previously for OVC. * Has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline OVC. * 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. Subjects with untreated and asymptomatic brain metastases or subjects with treated brain metastases who are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy, at the investigator's discretion. Note: If there is a history or suspicion of central nervous system metastasis, a CT scan of the head or MRI of the brain must be performed at baseline. * 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 or known family history of long QTsyndrome. * 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 pacemakers. * 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 (resting systolic blood pressure \>180 mm Hg or diastolic blood pressure \>110 mm Hg) * 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, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc) and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc), or prior pneumonectomy. * Chronic steroid treatment (\>10 mg/day), with the exception of the following: * Inhaled steroids for asthma or COPD * Mineralocorticoids (eg, fludrocortisone) for subjects 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, 5-year OS rate \>90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, ductal carcinoma in situ, or Stage 1 uterine cancer). * 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: Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade \>2 for 3 months prior to randomization and managed with SOC treatment) that the investigator deems related to previous anticancer therapy, following discussion with the Sponsor, such as the following: * Chemotherapy-induced neuropathy * Fatigue * Endocrinopathies, which may include hypothyroidism, hyperthyroidism, Type 1 diabetes, hyperglycemia, and adrenal insufficiency * Skin pigmentation (vitiligo) * 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). * 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 a known human immunodeficiency virus (HIV) infection that is not well controlled. Subjects must be tested for HIV viral load during the Screening Period if acceptable by local regulations or institutional review boards (IRBs)/ethics committees (ECs). All the following criteria are required to define an HIV infection that is well controlled: undetectable viral ribonucleic acid (RNA) load, CD4+ counts/levels of \>350 cells/μL, no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months, and stable for at least 3 weeks on the same anti-HIV retroviral medications. If an HIV infection meets the above criteria, the subject's viral RNA load and CD4+ cell count should be monitored per local SOC (eg, Q3M). * 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 subject to participate in the study or which would jeopardize compliance with the protocol. Screening for chronic conditions is not required. * Has an active or uncontrolled hepatitis B and/or hepatitis C infection. Subjects must be tested for hepatitis B (hepatitis B virus surface antigen \[HBsAg\] and anti-hepatitis B core antigen \[HBc\]) and hepatitis C virus antibody (HCV Ab) during the Screening Period. Subjects are eligible if they meet the following conditions: 1. Have been curatively treated for hepatitis C virus (HCV) infection as demonstrated by undetectable HCV RNA 2. Have received hepatitis B virus (HBV) vaccination with only anti-hepatitis B surface antibody (HBs) positivity and no clinical signs of hepatitis 3. Are HBsAg- and anti-HBc+ (ie, those who have cleared HBV after infection) and meet conditions i to iii of criterion "d" below 4. Are HBsAg+ with chronic HBV infection (lasting 6 months or longer) and meet conditions i to iii below: (i) HBV DNA viral load \<2000 IU/mL (ii) Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST/ALT \<3 × ULN that are not attributable to HBV infection (iii) Start or maintain antiviral treatment if clinically indicated as per the Investigator * 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 absorption, distribution, metabolism, or excretion of the study drug; or confound the assessment of study results. * 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 intervention. * For Phase 3 (Part B) only: Subjects are ineligible if they have a history of any contraindication included in the approved local label for the control group treatment.	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

* 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.
* 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 sample not required for the Phase 3 part of the study). Fresh pretreatment biopsy may be waived for subjects who consent to provide an archival tumor tissue sample from a lesion not previously irradiated, performed within 6 months of consent, and performed after treatment with their most recent cancer therapy regimen.
* Has received at least 1 but no more than 3 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: Subjects must have progressed radiologically on or after their most recent line of systemic therapy. Biochemical progression will not be considered progression for this study.
* 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 3 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.
* Has had prior poly-ADP ribose polymerase (PARP) inhibitors for participants with documented breast cancer gene mutation (germline and/or somatic), unless the participant is not eligible for treatment with a PARP inhibitor.
* Has had prior treatment with mirvetuximab soravtansine 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.
* 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.
* Required baseline local laboratory data (within 7 days before start of study drug administration):
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
* 3.0 × upper limit of normal (ULN) in subjects with no liver metastasis and
* 5.0 × ULN in subjects with liver metastasis
* Total bilirubin (TBL) ≤1.5 × ULN (\<3 × ULN for subjects with Gilbert's syndrome or liver metastasis at baseline)
* Absolute neutrophil count ≥1.5 × 109/L (growth factor support allowed up to 14 days before laboratory assessment for eligibility)
* Platelet count ≥100 × 109/L (transfusion allowed up to 14 days before laboratory assessment for eligibility)
* Hemoglobin ≥9.0 g/dL (transfusion and/or growth factor support allowed up to 14 days before laboratory assessment for eligibility)
* Creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation
* Serum albumin ≥2.5 g/dL
* Adequate blood clotting function: International normalized ratio and either activated partial thromboplastin time or partial thromboplastin time ≤1.5 × ULN, unless the subject is receiving anticoagulant therapy as long as activated partial thromboplastin time or partial thromboplastin time is within the therapeutic range of intended use of anticoagulants
* If the participant is a female of childbearing potential, she must have a negative serum pregnancy test at 72 hours before the first dose of study drug and must be willing to use highly effective birth control upon enrollment, during the Treatment Period, and for 7 months following the last dose of study drug. A female is considered of childbearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) with surgery at least 1 month before the first dose or confirmed by follicle-stimulating hormone test.
* Female participants must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final 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: Participants must be eligible for one of the treatments included in the Investigator's choice of chemotherapy arm and must not have received it previously for OVC.
* Has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline OVC.
* 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. Subjects with untreated and asymptomatic brain metastases or subjects with treated brain metastases who are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy, at the investigator's discretion. Note: If there is a history or suspicion of central nervous system metastasis, a CT scan of the head or MRI of the brain must be performed at baseline.
* 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 or known family history of long QTsyndrome.
* 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 pacemakers.
* 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 (resting systolic blood pressure \>180 mm Hg or diastolic blood pressure \>110 mm Hg)
* 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, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc) and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc), or prior pneumonectomy.
* Chronic steroid treatment (\>10 mg/day), with the exception of the following:
* Inhaled steroids for asthma or COPD
* Mineralocorticoids (eg, fludrocortisone) for subjects 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, 5-year OS rate \>90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, ductal carcinoma in situ, or Stage 1 uterine cancer).
* 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: Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to Grade \>2 for 3 months prior to randomization and managed with SOC treatment) that the investigator deems related to previous anticancer therapy, following discussion with the Sponsor, such as the following:
* Chemotherapy-induced neuropathy
* Fatigue
* Endocrinopathies, which may include hypothyroidism, hyperthyroidism, Type 1 diabetes, hyperglycemia, and adrenal insufficiency
* Skin pigmentation (vitiligo)
* 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).
* 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 a known human immunodeficiency virus (HIV) infection that is not well controlled. Subjects must be tested for HIV viral load during the Screening Period if acceptable by local regulations or institutional review boards (IRBs)/ethics committees (ECs). All the following criteria are required to define an HIV infection that is well controlled: undetectable viral ribonucleic acid (RNA) load, CD4+ counts/levels of \>350 cells/μL, no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months, and stable for at least 3 weeks on the same anti-HIV retroviral medications. If an HIV infection meets the above criteria, the subject's viral RNA load and CD4+ cell count should be monitored per local SOC (eg, Q3M).
* 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 subject to participate in the study or which would jeopardize compliance with the protocol. Screening for chronic conditions is not required.
* Has an active or uncontrolled hepatitis B and/or hepatitis C infection. Subjects must be tested for hepatitis B (hepatitis B virus surface antigen \[HBsAg\] and anti-hepatitis B core antigen \[HBc\]) and hepatitis C virus antibody (HCV Ab) during the Screening Period. Subjects are eligible if they meet the following conditions:
1. Have been curatively treated for hepatitis C virus (HCV) infection as demonstrated by undetectable HCV RNA
2. Have received hepatitis B virus (HBV) vaccination with only anti-hepatitis B surface antibody (HBs) positivity and no clinical signs of hepatitis
3. Are HBsAg- and anti-HBc+ (ie, those who have cleared HBV after infection) and meet conditions i to iii of criterion "d" below
4. Are HBsAg+ with chronic HBV infection (lasting 6 months or longer) and meet conditions i to iii below: (i) HBV DNA viral load \<2000 IU/mL (ii) Have normal transaminase values, or, if liver metastases are present, abnormal transaminases with a result of AST/ALT \<3 × ULN that are not attributable to HBV infection (iii) Start or maintain antiviral treatment if clinically indicated as per the Investigator
* 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 absorption, distribution, metabolism, or excretion of the study drug; or confound the assessment of study results.
* 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 intervention.
* For Phase 3 (Part B) only: Subjects are ineligible if they have a history of any contraindication included in the approved local label for the control group treatment.

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Medical Director Contact for Clinical Trial Information

CONTACT

908-992-6400

CTRinfo_us@daiichisankyo.com

Principal Investigator

Global Clinical Leader

STUDY_DIRECTOR

Daiichi Sankyo

Study Locations (Sites)

Alaska Women's Cancer Care

Anchorage, Alaska, 99508

United States

Yale University School of Medicine

New Haven, Connecticut, 06520

United States

Sylvester Comprehensive Cancer Center at Lennar

Coral Gables, Florida, 33146

United States

Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442

United States

Florida Cancer Specialists

Lake Mary, Florida, 32746

United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140

United States

Sylvester Cancer Center

Miami, Florida, 33136

United States

Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324

United States

Community MD Anderson Cancer Center- East

Indianapolis, Indiana, 46219

United States

Community MD Anderson Cancer Center- South

Indianapolis, Indiana, 46227

United States

Community Health Network - MD Anderson

Indianapolis, Indiana, 46250

United States

St. Elizabeth Medical Center

Edgewood, Kentucky, 41017

United States

Washington University School of Medicine Obstetrics and Gynecology

Saint Louis, Missouri, 63110

United States

Valley Health System

Paramus, New Jersey, 07652

United States

Holy Name

Teaneck, New Jersey, 07666

United States

NHPP Imbert

Bay Shore, New York, 11706

United States

Northwell Health, LLC PRIME

Lake Success, New York, 11042

United States

Perlmutter Cancer Center at NYU Langone Hospital- Long Island

Mineola, New York, 11501

United States

NYU Langone Health

New York, New York, 10016

United States

NHPP LHH

New York, New York, 10065

United States

Ohio State University Wexner Medical Center

Hilliard, Ohio, 43026

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Oklahoma Cancer Specialists and Research Institute

Tulsa, Oklahoma, 12967

United States

Perelman School of Medicine at the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4238

United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425

United States

Sanford Cancer Center Gynecologic Oncology

Sioux Falls, South Dakota, 57104

United States

Texas Oncology-Bedford

Bedford, Texas, 76022

United States

Texas Oncology-Presbyterian Cancer Center Dallas

Dallas, Texas, 75231

United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, 75246

United States

Texas Oncology Paris

Fort Worth, Texas, 76104

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Daiichi Sankyo

Global Clinical Leader, STUDY_DIRECTOR, Daiichi Sankyo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-27

Study Completion Date2029-12-31

Study Record Updates

Study Start Date2024-02-27

Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

Primary pertioneal cancer
Ovarian cancer
Fallopian tube cancer
Raludotatug Deruxtecan (R-DXd)
Cadherin 6 (CDH6)

Additional Relevant MeSH Terms

Solid Cancer