First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors

Inclusion Criteria

• •Sign and date the main Informed Consent Form (ICF).
• •Has a left ventricular ejection fraction ≥50% 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.
• •Has a histologically or cytologically documented locally advanced, metastatic, or unresectable solid malignant tumors.
• •Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria and documented radiographic disease progression during or after the most recent anticancer therapy.
• •Is able to provide either of the following baseline tumor samples:
• •* 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
• •* Biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy (if the sample amount is equivalent to core needle biopsy and processing after sample collection follows the procedure described in the Study Laboratory Manual)
• •* 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.