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A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors

NCT07887971

This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .

Summary

This is a Phase 1b, 2-part, multi-center, open-label study to evaluate the safety, tolerability, dosimetry, and pharmacokinetics (PK) of [64Cu]Cu-AKY-2519 and/or [225Ac]Ac-AKY-2519, as well as the preliminary anti-tumor activity of [225Ac]Ac-AKY-2519 in participants with B7-H3 imaging positive solid tumors.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • NSCLC
  • NSCLC (Advanced Non-small Cell Lung Cancer)
  • ES-SCLC
  • Small Cell Lung Cancer Extensive Stage
  • B7H3
  • Prostate Cancer
  • HNSCC
  • mCRPC (Metastatic Castration-resistant Prostate Cancer)
  • Head Neck Cancer Squamous Cell Metastatic
  • ESCC or Esophageal Adenosquamous Carcinoma
  • CRC
  • CRC (Colorectal Cancer)

Eligibility basics and study details

Study type
Interventional
Phase
Phase 1
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
Aktis Oncology, Inc.
Last updated on ClinicalTrials.gov
October 22, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Florida · 1

  • Biogenix Molecular, LLC · Miami, FL

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.