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NCT04707248Active, not recruitingPhase 1

A Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors

Phase I, Two-Part, Multi-Center, First-in-Human Study of DS-6000a in Subjects With Advanced Renal Cell Carcinoma and Ovarian Tumors

Source: ClinicalTrials.gov · Last updated 4 Sept 2026

Brief summary (registry, in English)

This clinical trial will evaluate raludotatug deruxtecan (R-DXd; DS-6000a) in participants with advanced renal cell carcinoma (RCC) and ovarian cancer (OVC). The main goals of this study will be to investigate the recommended dose of R-DXd that can be given safely to participants, assess the adverse events of R-DXd, and evaluate the effectiveness of R-DXd.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
179 (actual)
First submitted
16 Dec 2020
Start date
Dec 2020
Primary completion date
Dec 2026
Lead sponsor
Daiichi Sankyo
NCT number
NCT04707248

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 179
  • From Dec 2020 to the primary completion date, Dec 2026
  • 13 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has had prior treatment with other CDH6-targeted agents
  • Has had prior treatment with an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan, datopotamab deruxtecan, ifinatamab deruxtecan, DS-3939)
  • Has history or current presence of CNS metastases except for participants who have completed radiotherapy or surgery ≥2 weeks before the start of study treatment and have no evidence of disease progression in the CNS and no requirement for chronic corticosteroid therapy within 2 weeks before the start of study treatment
  • Has a history of myocardial infarction or unstable angina within 6 months before start of study treatment

Other illness

  • Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a cardiac arrhythmia requiring treatment
  • Lung-specific intercurrent clinically significant illnesses
  • Has an uncontrolled infection requiring systemic therapy

Age

  • Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years)

Who the study is looking for

  • Written informed consent
  • At least 18 years of age
  • Eastern Cooperative Oncology Group Performance Status score of 0 or 1
  • Availability of archived tumor tissue samples
  • Has a left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before start of study treatment
  • Has adequate organ function within 7 days before the start of study treatment
  • Has an adequate treatment washout period prior to start of study treatment
  • Male participants with female partners of childbearing potential and female participants of child-bearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 4 months (for males) and for at least 7 months (for females) after the last dose of study drug.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (13)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National Cancer Center Hospital
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Chuo KuJapanUnknown status
National Hospital Organization Kyusyu Cancer Center
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FukuokaJapanUnknown status
National Cancer Center Hospital East
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Kashiwa-shiJapanUnknown status
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
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KōtokuJapanUnknown status
National Hospital Organization Shikoku Cancer Center
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MatsuyamaJapanUnknown status
Shizuoka Cancer Center
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NakatogariJapanUnknown status
Saitama Medical University International Medical Center
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SaitamaJapanUnknown status
Rocky Mountain Cancer Center
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DenverUnited StatesUnknown status
Florida Cancer Lake Mary
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Lake MaryUnited StatesUnknown status
Vanderbilt-Ingram Cancer Center
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NashvilleUnited StatesUnknown status
SCRI Oncology Partners
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NashvilleUnited StatesUnknown status
Oklahoma University
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Oklahoma CityUnited StatesUnknown status
Arizona Oncology Associates, PC HOPE (A)A HOPE)
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TucsonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.