Ovarian Cancer Clinical Trial

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

Summary

This clinical trial will evaluate 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 DS-6000a that can be given safely to participants, assess the side effects of DS-6000a, and evaluate the effectiveness of DS-6000a.

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Full Description

DS-6000a is an antibody drug conjugate that specifically binds to CDH6 on the cell surface of target cells, which leads to the internalization of DS-6000a into the cells. MAAA-1181a that is released from DS-6000a in the target cells inhibits cell replication and induces cell apoptosis.

This study will evaluate DS-6000a 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 DS-6000a 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 DS-6000a.

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Eligibility Criteria

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, DS-1062a, DS-7300a)
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 serious cardiac arrhythmia requiring treatment
Lung-specific intercurrent clinically significant illnesses
Has an uncontrolled infection requiring systemic therapy

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

110

Study ID:

NCT04707248

Recruitment Status:

Recruiting

Sponsor:

Daiichi Sankyo, Inc.

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There are 10 Locations for this study

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Florida Cancer Lake Mary
Lake Mary Florida, 32746, United States More Info
Site Coordinator
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Oklahoma University
Oklahoma City Oklahoma, 73104, United States More Info
Principal Investigator
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Sydney Kimmel Cancer Center at Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
Tennessee Oncology-Nashville
Nashville Tennessee, 37203, United States More Info
Principal Investigator
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Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States More Info
Site Coordinator
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National Cancer Center Hospital
Chuo Ku Tokyo, 104-0, Japan More Info
Principal Investigator
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National Cancer Center Hospital East
Kashiwa-shi Tokyo, 277-8, Japan More Info
Principal Investigator
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The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-Ku , 135-0, Japan More Info
Principal Investigator
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National Hospital Organization Shikoku Cancer Center
Matsuyama , 791-0, Japan More Info
Principal Investigator
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Shizuoka Cancer Center
Nagaizumi , 411-8, Japan More Info
Principal Investigator
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How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

110

Study ID:

NCT04707248

Recruitment Status:

Recruiting

Sponsor:


Daiichi Sankyo, Inc.

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