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Can a new drug target Hard-to-Treat kidney and ovarian cancers?

NCT ID NCT04707248

Disease control Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests an experimental drug called DS-6000a (also known as R-DXd) in people with advanced renal cell carcinoma (kidney cancer) and ovarian tumors. The main goals are to find a safe dose, identify side effects, and see if the drug can shrink tumors. Participants receive the drug through an IV, and the study tracks their health and response over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
raludotatug deruxtecan (R-DXd; DS-6000a), an experimental antibody-drug conjugate given intravenously
What this could lead to
If it works, this could lead to a new treatment option for advanced kidney and ovarian cancers that have not responded to other therapies.
What could go wrong
This is an early, first-in-human trial, so the drug may not be safe or effective at the tested doses. Side effects could be significant, and the results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

179 people

The number who actually took part.

Started

Dec 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 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) * Has a history of myocardial infarction or unstable angina within 6 months before start of study treatment * 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

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Conditions

The condition(s) this trial relates to.

ovarian cancer ovarian neoplasm renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ovarian tumor Renal cell carcinoma

Contacts and locations

Locations

  • Arizona Oncology Associates, PC HOPE (A)A HOPE)

    Tucson, Arizona, 85711, United States

  • Florida Cancer Lake Mary

    Lake Mary, Florida, 32746, United States

  • National Cancer Center Hospital

    Chuo Ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Tokyo, 277-8577, Japan

  • National Hospital Organization Kyusyu Cancer Center

    Fukuoka, 811-1395, Japan

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, 791-0280, Japan

  • Oklahoma University

    Oklahoma City, Oklahoma, 73104, United States

  • Rocky Mountain Cancer Center

    Denver, Colorado, 80218, United States

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203, United States

  • Saitama Medical University International Medical Center

    Saitama, 350-1298, Japan

  • Shizuoka Cancer Center

    Nakatogari, 411-8777, Japan

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Kōtoku, 135-0063, Japan

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

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