TheranosticTrials.org

Clinical Trial · NCT07887971

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

Overview

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.

Sponsor

Unknown Organization

Phase

Phase 1

ClinicalTrials.gov

NCT07887971

Drug / Compound

AKY-2519

Isotope(s):
Target(s):
  • B7-H3
Ligand Class: Small Proteins and Antibody Fragments
Chelator: DOTA
Linker: short polyethylene glycol linker

AKY-2519

Isotope(s):
Target(s):
  • B7-H3
Ligand Class: Small Proteins and Antibody Fragments
Chelator: DOTA
Linker: short polyethylene glycol linker

Eligibility

Inclusion

  • Histologic or cytologic confirmation of locally advanced or metastatic NSCLC, ES-SCLC, HNSCC, ESCC, CRC or prostatic adenocarcinoma
  • Patients with CNS metastases are eligible if they have received therapy and are neurologically stable, asymptomatic and not receiving corticosteroids
  • Radiologic confirmation on CT of at least one measurable tumor lesion per RECIST v1.1
  • Adequate end-organ function
  • ECOG Performance Status of 0 or 1

Exclusion

  • Concurrent serious medical condition that would impair study participation or impact the assessment of treatment related toxicity
  • Impaired cardiac function or clinically significant cardiac disease
  • Prior treatment with a cytotoxic chemotherapy, targeted therapy, biologic agent, immunotherapy or external-beam radiotherapy within the previous 28 days
  • Prior treatment with a B7-H3 targeted therapy
  • Received an investigational agent within the previous 28 days
  • Prior treatment with a targeted radiotherapy