Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 study start - 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 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 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 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 Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Escalation
Participants with ovarian cancer (OVC) or renal cell carcinoma (RCC) will receive an intravenous infusion of DS-6000a (starting dose 1.6 mg/kg).
  • Drug: DS-6000a
    Intravenous administration at doses starting at 1.6 mg/kg on Day 1 of Cycle 1
Experimental
Dose Expansion: Cohort B-1
Participants with RCC will receive an intravenous infusion of DS-6000a at the RDE.
  • Drug: DS-6000a
    Intravenous administration at RDE on Day 1 of Cycle 1
Experimental
Dose Expansion: Cohort B-2
Participants with OVC will receive an intravenous infusion of DS-6000a at the RDE.
  • Drug: DS-6000a
    Intravenous administration at RDE on Day 1 of Cycle 1

Recruiting Locations

Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232
Contact:
Site Coordinator

More Details

Status
Recruiting
Sponsor
Daiichi Sankyo, Inc.

Study Contact

(US sites) Daiichi Sankyo Contact for Clinical Trial Information
908-992-6400
CTRinfo@dsi.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.