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

NCT06840535 | Completed Phase 1

• 2 other identifiers: PH-ACP3GA-01/242024-515608-38-00
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Prostate Cancer Metastatic Disease; Prostate Cancer; PSA Level Greater Than 0.2

Outcome Measures

Primary Outcomes (3)

• Cohort A: Dosimetry - Effective dose equivalent (mSv)

  Whole-body effective dose (mSv) following administration of a single dose of \[68Ga\]Ga-OncoACP3.

  Assessed on day 1

• Cohort A: Dosimetry - Effective dose absorbed doses (mGy)

  Absorbed doses (mGy) of normal organs following administration of a single dose of \[68Ga\]Ga-OncoACP3.

  Assessed on day 1

• All patients: Safety (AEs and SAEs)

  Safety of administration of \[68Ga\]Ga-OncoACP3, assessed based on Common Toxicity Criteria (CTCAE version 5.0)

  Throughout study, until a maximum of 7 days after the administration of the study drug.

Secondary Outcomes (5)

• Pharmacokinetics (PK) - Blood

  Assessed on day 1

• Excretion - Urine

  Assessed on day 1

• Biodistribution profile: SUVmax

  Assessed on day 1

• Biodistribution profile: SUVmean

  Assessed on day 1

• Biodistribution profile: SUVsd

  Assessed on day 1

Other Outcomes (2)

• Immunopathology staining

  Within 8 weeks of the scan, surgery and biopsy collection

• Lesion detection rate

  The [68Ga]Ga-OncoACP3-PET/CT scan needs to be collected within 4 weeks

Study Arms (2)

Coort A

EXPERIMENTAL

5 male patients without visceral or bone metastases, which would interfere with dosimetry evaluation of healthy organs.

Coort B

EXPERIMENTAL

All patients who meet the eligibility criteria (up to 15 patients)

Drug: [68Ga]Ga-OncoACP3

Interventions

[68Ga]Ga-OncoACP3 DRUG

Single intravenous bolus injection.

Coort B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prostate cancer patients with:
• suspected metastasis who are candidates for initial definitive therapy
• suspected recurrence based on elevated serum prostate-specific antigen (PSA) level (i.e., a progressive and confirmed serum PSA level \> 0.2 ng/mL)
• metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands
• 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 confirmed diagnosis of prostate cancer.
• Subjects able to father children must agree to practice effective contraception for three months starting from the study drug administration.
• Age ≥ 18
• ECOG ≤ 1
• Patient must not have any concomitant infections or active concomitant disease.
• 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. 5.0) Grade ≤ 1.
• Life expectancy of more than 12 weeks.
• Ability to undergo imaging study procedures.
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
• Willingness and ability to comply with the scheduled visits, plan, laboratory tests and other study procedures.

You may not qualify if:

• Chronically impaired renal function as expressed by creatinine clearance \< 60 mL/min or serum creatinine \> 1.5 x ULN.
• Presence of active hepatitis.
• 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).
• Any concomitant condition which in the opinion of investigators makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol.
• Serious, non-healing wound, ulcer, or bone fracture.
• Allergy to study medication or excipients in study medication.
• 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.

Sponsors & Collaborators

• Philogen S.p.A.: lead

Study Sites (3)

ASST Papa Giovanni XXIII

Bergamo, BG, 24127, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Milano, 20132, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Milano, 20133, Italy

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients are divided into two cohorts: * Cohort A: 5 male patients without visceral or bone metastases, which would interfere with dosimetry evaluation of healthy organs. * Cohort B: all patients who meet the eligibility criteria (up to 15 patients)

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: April 8, 2025
• Primary Completion: October 3, 2025
• Study Completion: October 3, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)