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

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.

Trial Details

NCT ID
NCT07887971
Phase
PHASE1
Sponsor
Aktis Oncology, Inc.
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • [225Ac]Ac-AKY-2519 (therapeutic)
  • [64Cu]Cu-AKY-2519 (imaging)
Locations (sample)
  • Miami, Florida, United States|25.77427,-80.19366
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Age ≥ 18 years
  • Histologic or cytologic confirmation of locally advanced or metastatic NSCLC, ES-SCLC, HNSCC, ESCC, CRC or prostatic adenocarcinoma
  • Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1
  • ECOG Performance Status of 0 or 1

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Prostate Cancer Trials on Trialify →