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

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.

Trial Details

NCT ID
NCT07020117
Phase
PHASE1
Sponsor
Aktis Oncology, Inc.
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • [225Ac]Ac-AKY-1189 (therapeutic)
  • [64Cu]Cu-AKY-1189 (imaging)
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Irvine, California, United States|33.66946,-117.82311
  • Miami, Florida, United States|25.77427,-80.19366
  • Iowa City, Iowa, United States|41.66113,-91.53017
  • Glen Burnie, Maryland, United States|39.16261,-76.62469

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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