[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

908-992-6400

Email address

CTRinfo@dsi.com

Condition

Ovarian Tumor,Renal Cell Carcinoma

Treatment type

Interventional

Investigational product

DS-6000a

Phase

Phase 1

Sponsor

Daiichi Sankyo, Inc.

ClinicalTrials.gov identifier

NCT04707248

Study number

DS6000-A-U101

Understanding clinical trials

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About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

  1. Written informed consent
  2. At least 18 years of age
  3. Eastern Cooperative Oncology Group Performance Status score of 0 or 1
  4. Availability of archived tumor tissue samples
  5. 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
  6. Has adequate organ function within 7 days before the start of study treatment
  7. Has an adequate treatment washout period prior to start of study treatment
  8. 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

  1. Has had prior treatment with other CDH6-targeted agents
  2. 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)
  3. 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
  4. 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)
  5. Has a history of myocardial infarction or unstable angina within 6 months before start of study treatment
  6. Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or a serious cardiac arrhythmia requiring treatment
  7. Lung-specific intercurrent clinically significant illnesses
  8. Has an uncontrolled infection requiring systemic therapy

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

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