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 a history of noninfectious interstitial lung disease (ILD)/pneumonitis (including suspected one), has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.

Trial design

Treatments tested in this trial

  • DS-3939a

Treatment groups

540 Participants
are divided into 2 treatment groups

Locations

33
Belgium
UZ Leuven3000, Leuven Belgium
Canada
McGill University Health CenterH4A 3J1, Montreal Canada
Princess Margaret Cancer CenterM5G2M9, Toronto Canada
China
Beijing Cancer Hospital100142, Beijing China

Sponsors and collaborators

Daiichi Sankyo

Lead sponsor