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

May 13, 2026 updated by: Philogen S.p.A.
The aim of this study is to assess the safety and dosimetry of imaging with [68Ga]Ga-OncoACP3 in patients with prostate cancer.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a phase I, non-randomized, open-label, multicenter clinical trial to evaluate primary the safety and dosimetry of a single dose of [68Ga]Ga-OncoACP3 and, secondly, its uptake, biodistribution, PK and excretion.

The Acid Phosphatase 3 (ACP3) is expressed in primary and metastatic prostate cancer lesions. OncoACP3 is a new ligand for ACP3: its radiolabelled version can be used as a PET radiotracer for the diagnostic imaging of prostate cancer. In this trial, 68Ga-OncoACP3 is offered to prostate cancer patients who already received standard of care imaging and might therefore complement available modalities.

Eligible patients for this trial are prostate cancer patients, aged 18 years or more 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.

All patients will undergo PET/CT imaging with [68Ga]Ga-OncoACP3.

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) Both cohorts are recruited in parallel, and patients are assigned to the respective cohort based on their disease extent. Whenever possible, patients are enrolled in cohort A, unless they are unsuitable for cohort A, or the required number of patients has already been enrolled in cohort A.

All patients will receive a single intravenous bolus administration of 250 MBq (150 - 275 MBq) [68Ga]Ga-OncoACP3 and biodistribution, PK, excretion, and dosimetry of [68Ga]Ga-OncoACP3 will be assessed based on a series of PET/CT scans, blood and urine sampling.

Full dosimetry evaluations will be performed for all patients in cohort A. Dosimetry in the other patients may be performed to the extent that it is possible based on their disease burden (i.e., only organs not affected by malignant lesions can be evaluated), as appropriate.

All patients will be assessed for safety. In addition, relative uptake to appropriate reference tissue of [68Ga]Ga-OncoACP3 as well as semiquantitative parameters such as SUVmax/SUVmean/SUVsd, are determined. The correlation of [68Ga]Ga-OncoACP3 uptake with immunopathology staining for ACP3 will be evaluated in patients undergoing surgery or tumor biopsy collection. For patients who undergo PSMA-PET/CT within 6 weeks before or after the [68Ga]Ga-OncoACP3-PET/CT scan, the lesion detection rate will be compared.

Full dosimetry evaluations will be performed for all patients in cohort A. Dosimetry in the other patients may be performed to the extent that it is possible based on their disease burden (i.e., only organs not affected by malignant lesions can be evaluated), as appropriate.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Bergamo
      • Bergamo, Bergamo, Italy, 24127
        • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
        • Principal Investigator:
          • Paola Anna Erba, Prof
    • Milano
      • Milan, Milano, Italy, 20132
        • Ospedale San Raffaele S.r.l.
        • Principal Investigator:
          • Arturo Chiti, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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. (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)
  2. Subjects able to father children must agree to practice effective contraception for three months starting from the study drug administration.
  3. Age ≥ 18
  4. ECOG ≤ 1
  5. Patient must not have any concomitant infections or active concomitant disease.
  6. 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.
  7. Life expectancy of more than 12 weeks.
  8. Ability to undergo imaging study procedures.
  9. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
  10. Willingness and ability to comply with the scheduled visits, plan, laboratory tests and other study procedures.

Exclusion Criteria:

  1. 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
  2. Presence of active hepatitis.
  3. 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).
  4. 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.
  5. 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.
  6. Serious, non-healing wound, ulcer, or bone fracture.
  7. Allergy to study medication or excipients in study medication.
  8. Any anti-cancer therapy (e.g., cytotoxic chemotherapy, immunotherapy, radiation, surgery, etc.) within 3 weeks before [68Ga]Ga-OncoACP3-PET/CT scan.
  9. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A
5 male patients without visceral or bone metastases, which would interfere with dosimetry evaluation of healthy organs.
Drug: [68Ga]Ga-OncoACP3
Single intravenous bolus injection.
Experimental: Cohort B
All patients who meet the eligibility criteria (up to 15 patients).
Drug: [68Ga]Ga-OncoACP3
Single intravenous bolus injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Throughout study, until a maximum of 7 days after the administration of the study drug.
Adverse events (AEs) and Serious Adverse Events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE) v.6.0.
Throughout study, until a maximum of 7 days after the administration of the study drug.
Effective dose equivalent (mSv) and absorbed doses (mGy)
Time Frame: Assessed on day 1
Effective dose equivalent (mSv) and absorbed doses (mGy) of normal organs following administration of a single dose of [68Ga]Ga-OncoACP3.
Assessed on day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philogen S.p.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 20, 2026

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PH-ACP3GA-03/25
  • 2025-524594-16-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on [68Ga]Ga-OncoACP3

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe