Phase 12a Study of DB-1419 Injection for Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are conducting a Phase 12a clinical trial to evaluate DB-1419, a drug given by intravenous injection, for people with advanced or metastatic solid tumors that have relapsed, progressed, or have no standard treatment options. This open-label, multicenter study aims to assess the safety, tolerability, how the drug is processed in the body, and early signs of antitumor activity in participants. The trial is sponsored by DualityBio Inc. and includes adults aged 18 and older with measurable tumors or bone-only disease in some cases. Participants receive DB-1419 at various dose levels ranging from Dose Level 1 up to Dose Level 9. The study is non-randomized and includes dose escalation and dose expansion phases to determine the maximum tolerated dose and recommended dose for further study. The drug is administered by vein injection, and dosing cycles last either 14 or 21 days, with up to 8 cycles monitored for pharmacokinetics and immune response markers. During the study, participants undergo tumor assessments using RECIST v1.1 criteria to measure response, as well as monitoring for adverse events and serious adverse events for up to 90 days after the last dose or before new cancer treatment begins. Additional tests include cardiac function evaluation, blood tests for drug levels and antibodies, and physical exams. The study tracks progression-free survival, overall survival, and other safety and efficacy outcomes for approximately 12 months. Participants must provide consent and comply with study procedures throughout this period.

First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors