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โ† Trials
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First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllDaiichi Sankyo
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In plain words

What the trial is, and whether it could suit you

This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Sign and date the main Informed Consent Form (ICF). * Has a left ventricular ejection fraction โ‰ฅ50% by either an echocardiogram or multigated acquisition within 28 days of enrollment. * Has adequate organ function. * Measurable disease based on RECIST V1.1. * Eastern Cooperative Oncology Group performance status score of 0 or 1. Additional inclusion criteria for Part 1 * Has a histologically or cytologically documented locally advanced, metastatic, or unresectable solid malignant tumors. Additional inclusion criteria for Part 2 * Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria * Is able to provide either of the following baseline tumor samples: 1. Fresh tumor biopsy samples meeting either of the following requirements that were obtained during the Main Screening or Tissue Screening Period, or * Fresh core needle biopsy sample * Fresh biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy, or other procedures as long as the sample amount is equivalent to core needle biopsy and processing after sample collection follows the procedure described in the Study Laboratory Manual. 2. FFPE tumor tissue samples obtained by biopsy or surgery performed within 6 months before signing the main ICF. If samples were obtained prior to the start of the most recent anticancer therapy, the Sponsor Medical Monitor should be consulted regarding the adequacy of the sample. Exclusion Criteria: * Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1. * Has spinal cord compression or clinically active central nervous system metastases. * 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 โ‰ฅ3 years. * Has any history of ILD/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening. Participants may be eligible if they had history of radiation pneumonitis that did not require steroids. * Has active or uncontrolled human immunodeficiency virus (HIV) infection. * Has evidence of active or uncontrolled hepatitis B virus or hepatitis C virus infection. * Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event. * Has an active (ie, symptomatic and/or on-treatment), known, or suspected autoimmune disease. * Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment.
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What it tests

  • DS-3939a
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Where

61 sites
Florida Cancer Specialists
Sarasota, United States
Florida Cancer Specialists
Sarasota, United States
Piedmont Cancer Institute
Locust Grove, United States
University of Kansas Medical Center
Westwood, United States
Henry Ford Health System
Detroit, United States
Astera Cancer Care
East Brunswick, United States
Icahn School of Medicine Mt Sinai
New York, United States
Oregon Health & Science University
Portland, United States

โ€ฆand 53 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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