First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDaiichi Sankyo
About this trial
This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 ≥3 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.
Trial design
Treatments tested in this trial
- DS-3939a
Treatment groups
590 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov