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

Condition(s) studied

Investigational drug(s) / intervention(s)

[225Ac]Ac-AKY-1189 (therapeutic): \[225Ac\]Ac-AKY-1189 Injection

[64Cu]Cu-AKY-1189 (imaging): \[64Cu\]Cu-AKY-1189 Injection

Study summary

This is a first-in-human Phase 1b, 2-part, multicenter open-label clinical study to evaluate safety and efficacy of a Nectin-4 radiopharmaceutical (\[225Ac\]Ac-AKY-1189) in patients with locally advanced or metastatic solid tumors and to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose.

Eligibility

Primary outcome measure(s)

• Part 1: Number of Patients with Dose-Limiting Toxicities — From enrollment to the end of Cycle 1 (each cycle is 28 days)
  • Dose-limiting toxicities (DLTs) is defined as any predefined AE occurring during the DLT observation period, except those that are clearly and incontrovertibly due to extraneous circumstances. The number of patients who experience a DLT in Part 1, will be reported by dose level.
• Part 1: Occurence of Adverse Events by Severity — Up to the End of Treatment (30 days after the last dose)
  • An AE is defined as any untoward medical occurrence in a participant administered study drug, which does not necessarily have to have a causal relationship with the study drug. The number of patients experiencing an AE in Part 1 will be reported.
• Part 2: Objective Response Rate (ORR) — Up to 30 days following last administration
  • Objective response rate is defined as the percentage of patients who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator based on RECIST 1.1, by tumor types.

Trial sites (14)