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

Last updated: December 19, 2024
Sponsor: Daiichi Sankyo
Overall Status: Active - Not Recruiting

Phase

1

Condition

Renal Cell Carcinoma

Carcinoma

Kidney Cancer

Treatment

DS-6000a

Clinical Study ID

NCT04707248
DS6000-A-U101
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 studytreatment

  • 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 femaleparticipants of child-bearing potential must agree to use a highly effective form ofcontraception or avoid intercourse during and upon completion of the study and forat least 4 months (for males) and for at least 7 months (for females) after the lastdose of study drug.

Exclusion

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 isa 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 havecompleted radiotherapy or surgery ≥2 weeks before the start of study treatment andhave no evidence of disease progression in the CNS and no requirement for chroniccorticosteroid therapy within 2 weeks before the start of study treatment

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

  • Has a history of myocardial infarction or unstable angina within 6 months beforestart of study treatment

  • Has a medical history of symptomatic congestive heart failure (New York HeartAssociation classes II-IV) or a cardiac arrhythmia requiring treatment

  • Lung-specific intercurrent clinically significant illnesses

  • Has an uncontrolled infection requiring systemic therapy

Study Design

Total Participants: 179
Treatment Group(s): 1
Primary Treatment: DS-6000a
Phase: 1
Study Start date:
December 22, 2020
Estimated Completion Date:
November 30, 2025

Study Description

R-DXd is an antibody drug conjugate that specifically binds to CDH6 on the cell surface of target cells, which leads to the internalization of R-DXd into the cells. MAAA-1181a that is released from R-DXd in the target cells inhibits cell replication and induces cell apoptosis.

This study will evaluate R-DXd given as a single agent once every 21 days. The dose escalation phase will enroll participants with OVC and RCC, and is designed to assess the safety and tolerability of R-DXd and to determine the maximum tolerated dose (MTD)/recommended dose for expansion (RDE). Following the selection of the RDE, the dose expansion phase will be initiated to evaluate clinical activity of R-DXd.

Connect with a study center

  • National Cancer Center Hospital

    Chuo Ku, Tokyo 104-0045
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa-shi, Tokyo 277-8577
    Japan

    Site Not Available

  • National Hospital Organization Kyusyu Cancer Center

    Fukuoka, 811-1395
    Japan

    Site Not Available

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-Ku, 135-0063
    Japan

    Site Not Available

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, 791-0280
    Japan

    Site Not Available

  • Shizuoka Cancer Center

    Nagaizumi, 411-8777
    Japan

    Site Not Available

  • Saitama Medical University International Medical Center

    Saitama, 350-1298
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Tokyo, 104-0045
    Japan

    Site Not Available

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

    Tucson, Arizona 85711
    United States

    Site Not Available

  • Rocky Mountain Cancer Center

    Denver, Colorado 80218
    United States

    Site Not Available

  • Florida Cancer Lake Mary

    Lake Mary, Florida 32746
    United States

    Site Not Available

  • Oklahoma University

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Sydney Kimmel Cancer Center at Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • SCRI Oncology Partners

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Tennessee Oncology-Nashville

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

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.