First-in-Human Trial of DS3610a in Participants with Advanced Solid Tumors

No primary or secondary objectives are specified in the provided information.

The trial enrolled 46 participants diagnosed with Advanced Solid Tumors. Both male and female adults were eligible, encompassing individuals classified within the adult (age code 3) and older adult (age code 4) age ranges. Subjects were recruited from the patient population meeting the disease diagnosis, with inclusion of individuals considered vulnerable under regulatory definitions. General health status was limited to the presence of the specified malignancy; no additional health or lifestyle criteria were detailed. Selection was based on confirmed diagnosis, and standard exclusion criteria related to concurrent illnesses or therapies were applied in accordance with typical oncology trial protocols.

The study is a Phase 1, open‑label, first‑in‑human trial evaluating DS3610a in adults with Advanced Solid Tumors. After a screening visit to confirm eligibility, participants receive the investigational drug and attend scheduled follow‑up visits for safety, pharmacokinetic, and efficacy assessments. Participant involvement continues until the planned end‑of‑study visit, which includes final evaluations and discontinuation of the study drug. Early termination may occur if a participant experiences a dose‑limiting toxicity, withdraws consent, or is unable to comply with required assessments. Recruitment is planned to commence in June 2026 and conclude by December 2030.

Efficacy will be evaluated in accordance with the predefined study protocol.