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Phase 1Recruiting

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

Sponsored by Aktis Oncology, Inc.

About this study

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.

This study consists of two parts (Part 1 and 2). Part 1 is the dose escalation portion of the study, which will investigate ascending doses of \[225Ac\]Ac-AKY-1189 (up to 6 cycles) in patients with locally advanced or metastatic solid tumors. The aim of Part 1 is to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended Phase 2 dose. Part 2 will be the dose expansion portion of the study and will enroll locally advanced or metastatic solid tumor patients who are identified as Nectin-4 positive by \[64Cu\] Cu-AKY-1189. Part 2 aims to further assess the efficacy of \[225Ac\]Ac-AKY-1189 at the RP2D in 3 different cohorts of patients.

Where this study is enrolling (14)

Show all 14 locations
Who can participate

Inclusion criteria

  • ✓Histologic or cytologic confirmation of locally advance or metastatic disease
  • ✓Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1
  • ✓ECOG Performance Status of 0 or 1
  • ✓Adequate end-organ function
  • ✓Ability to give informed consent and comply with study requirements
  • ✓Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids
  • ✓Documented disease progression on prior line of therapy for metastatic disease

Exclusion criteria

  • ✕Prior treatment with a therapeutic radiopharmaceutical
  • ✕Prior treatment with a Nectin-4 targeted therapy, except enfortumab vedotin
  • ✕Received an investigational agent within the previous 28days
  • ✕Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy in the 3 weeks prior to study treatment
  • ✕Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity

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Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.