TheranosticTrials.org

Clinical Trial · NCT07600554

A Phase I Study to Evaluate the Safety and Dosimetry of Imaging With 68Ga-OncoACP3 in Prostate Cancer

Overview

The aim of this study is to assess the safety and dosimetry of imaging with \[68Ga\]Ga-OncoACP3 in patients with prostate cancer.

Sponsor

Philogen S.p.A.

Phase

Phase 1

Contacts

Francesco Colognese (CONTACT)

regulatory@philogen.com

+39 0577 17 816

Jacqueline Mock (CONTACT)

regulatory@philogen.com

+41 43 544 88 02

ClinicalTrials.gov

NCT07600554

Drug / Compound

OncoACP3

Isotope(s):
Target(s):
  • Acid Phosphatase 3 (ACP3)
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • suspected recurrence based on elevated serum prostate-specific antigen (PSA) level (i.e., a progressive and confirmed serum PSA level \> 0.2 ng/mL)
  • Prostate cancer patients with:
  • ECOG ≤ 1
  • All acute toxic effects (excluding alopecia and fatigue) of any prior therapy (including surgery, radiation therapy, chemotherapy) must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v. 6.0) Grade ≤ 1.
  • metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands. (Note: patients with a negative PSMA-PET/CT or discordant PSMA-PET and FDG-PET findings are eligible for this study, providing that they have a histologically confirmed diagnosis of prostate cancer)
  • suspected metastasis who are candidates for initial definitive therapy

Exclusion

  • Presence of significant cardiac disorders (congestive heart failure, NYHA class III-IV, myocardial infarction within one year prior to study entry, uncontrolled hypertension, or arrhythmia).
  • Presence of active hepatitis.
  • Chronically impaired renal function as expressed by creatinine clearance \< 60 mL/min or serum creatinine \> 1.5 x ULN. Note: it is sufficient to evaluate either creatinine clearance or serum creatinine
  • Major trauma including major surgery (such as abdominal/cardiac/thoracic surgery) within 4 weeks of administration of the study drug. Minimally invasive procedures such as biopsies are not considered as exclusion criteria.
  • Serious, non-healing wound, ulcer, or bone fracture.
  • Any anti-cancer therapy (e.g., cytotoxic chemotherapy, immunotherapy, radiation, surgery, etc.) within 3 weeks before \[68Ga\]Ga-OncoACP3-PET/CT scan.
  • Subject has received, or is scheduled to receive, another investigational medicinal product (IMP) from one month before \[68Ga\]Ga-OncoACP3 injection to end of study participation.