Phase 1b Study of 225AcAc-AKY-1189 to Assess Safety and Effectiveness in Adults With Advanced or Metastatic Solid Tumors Positive for Nectin-4

What this Trial Is About

Researchers are evaluating the safety and efficacy of a new radiopharmaceutical called 225AcAc-AKY-1189 in patients with locally advanced or metastatic solid tumors. This first-in-human, Phase 1b, two-part, open-label study aims to find the maximum tolerated or maximum administered dose and recommend a dose for further study. The study includes patients with various solid tumors who have previously been treated and have confirmed disease progression. The study has two parts Part 1 is a dose escalation phase where patients receive increasing doses of 225AcAc-AKY-1189 up to six cycles to determine safe dosing levels. Part 2 is a dose expansion phase enrolling patients with Nectin-4 positive tumors identified by 64CuCu-AKY-1189 imaging. In Part 2, participants receive the recommended Phase 2 dose to further assess effectiveness in three different patient cohorts. Participants undergo assessments including scans to confirm tumor size and Nectin-4 status, evaluations of organ function, and performance status checks. Safety and response to treatment are monitored through adverse event tracking and tumor response rates. The study measures outcomes such as dose-limiting toxicities, objective response rates, duration of response, and progression-free survival. Follow-up can last up to five years after treatment begins, with the study completing by June 2032.

A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors