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Breast CancerPhase 1FAPrimoNCT05784597

A Study to Evaluate the Safety and Dosimetry of 68Ga-labelled OncoFAP Derivatives in Solid Tumors

A Phase 1 study testing [68Ga]Ga-OncoFAP administration in people with Breast Cancer and Colorectal Cancer, run by Philogen S.p.A. at 5 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objectives of this trial are to evaluate the safety and dosimetry of [68Ga]Ga-OncoFAP for detection/imaging of solid tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
[68Ga]Ga-OncoFAP administration
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
5 sitesItaly
Study dates
27 Apr 2023to 21 Oct 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a confirmed diagnosis of breast cancer, colorectal cancer, oesophageal cancer and pancreatic adenocarcinoma. Confirmation by histopathology is required for breast, colorectal and oesophageal cancer. For pancreatic adenocarcinoma, confirmation by histopathology or cytology obtained by endoscopic ultrasound is accepted.
  • Requirement for diagnostic imaging or imaging performed within 4 weeks prior to the [68Ga]Ga-OncoFAP-PET/CT scan for staging.
  • Male or non-pregnant and non-breastfeeding female.
  • For female patients: negative serum pregnancy test for women of childbearing potential* (WOCBP).
  • WOCBP must agree to use, from the screening to six months following the study drug administration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group (www.hma.eu/ctfg.html) and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion or vasectomized partner.
  • For male patients: male subject able to father children must agree to practice effective contraception for three months starting from the study drug administration.
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  • Age 18 - 75
  • ECOG ≤ 1
  • Patient must not have any concomitant infections or active concomitant disease.
  • 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.
  • Women of childbearing potential are defined as females who have experienced menarche, are not postmenopausal (12 months with no menses without an alternative medical cause) and are not permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).

Who cannot join

  • 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).
  • Pregnant or breastfeeding during participation in the study.
  • 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.
  • 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.
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  • 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-OncoFAP-PET/CT scan
  • Subject has received, or is scheduled to receive, another investigational medicinal product (IMP) from 1 month before [68Ga]Ga-OncoFAP injection to end of study participation.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Italy5 sites

  • IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori"

    Meldola, 47014

  • Istituto Nazionale dei Tumori | Fondazione IRCCS

    Milan, Milano, 20133

  • IRCCS San Raffaele

    Milan, 20132

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Pisa, 56126

  • Istituto Clinico Humanitas

    Rozzano, Milano, 20089

Other trials in Italy

About this study

Official title: A Phase I Study to Evaluate the Safety and Dosimetry of 68Ga-labelled OncoFAP Derivatives in Patients with Solid Tumors

The primary objectives of this trial are to evaluate the safety and dosimetry of [68Ga]Ga-OncoFAP for detection/imaging of solid tumors.

Read the detailed description

Phase I, multicenter study in patients with a confirmed diagnosis of solid tumor among breast cancer, colorectal cancer, oesophageal cancer and pancreatic adenocarcinoma, requiring clinical staging for nodal staging and/or metastatic disease (based on institutional practice and risk stratification). All patients will receive a single intravenous bolus administration of 250 MBq (225 - 275 MBq). [68Ga]Ga-OncoFAP biodistribution, PK, and dosimetry of [68Ga]Ga-OncoFAP will be assessed based on a series of PET/CT scans, blood and urine sampling.

Being tested
[68Ga]Ga-OncoFAP administration
Medical subject headings
Breast Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [68Ga]Ga-OncoFAP administrationDrug

    All patients will receive a single intravenous bolus administration of 250 MBq (225 - 275 MBq)

Study groups in NCT05784597
Study groupRoleWhat they receive
Cohort AExperimental3 female + 3 male patients with a primary tumor only
Receives: Drug: [68Ga]Ga-OncoFAP administration
Cohort BExperimentalPatients with a primary tumor and/or advanced/metastatic disease with a quantifiable number of lesions
Receives: Drug: [68Ga]Ga-OncoFAP administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety (AE)

    Safety of administration of 68Ga-OncoFAP, assessed based on Common Toxicity Criteria (CTCAE version 5.0)

    Measured: Throughout study, until a maximum of 8 days after the completion of each patient

  2. Cohort A: Dosimetry - Effective dose equivalent (mSv)

    Effective dose equivalent (mSv) of normal organs following administration of a single dose of [68Ga]Ga-OncoFAP, for patients in cohort A

    Measured: Assessed on day 1

  3. Cohort A: Dosimetry - Absorbed doses (mGy)

    Absorbed doses (mGy) of normal organs following administration of a single dose of [68Ga]Ga-OncoFAP, for patients in cohort A

    Measured: Assessed on day 1

Secondary outcomes (7)

  1. Biodistribution profile: SUVmax

    Uptake of [68Ga]Ga-OncoFAP in terms of SUVmax

    Measured: Assessed on day 1

  2. Biodistribution profile: SUVmean

    Uptake of [68Ga]Ga-OncoFAP in terms of SUVmean

    Measured: Assessed on day 1

  3. Biodistribution profile: SUVsd

    Uptake of [68Ga]Ga-OncoFAP in terms of SUVsd

    Measured: Assessed on day 1

  4. PK

    Pharmacokinetics of [68Ga]Ga-OncoFAP based on measurement of residual radioactivity in the blood over time [MBq/mL

    Measured: Assessed on day 1

  5. Excretion

    Metabolism and excretion of [68Ga]Ga-OncoFAP based on radioactivity measurements on urine collected at defined timepoints

    Measured: Assessed on day 1

  6. Immunopathology staining

    Correlation of [68Ga]Ga-OncoFAP uptake with immunopathology staining if and when surgical or biopsy specimen are available

    Measured: Assessed on day 1

  7. Lesion detection rate

    Lesion detection rate compared to standard imaging

    Measured: Assessed on day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2023
  2. Study start27 Apr 2023
  3. Primary completion21 Oct 2024
  4. Study completion21 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Patients are divided into two cohorts: * Cohort A: 3 female + 3 male patients with a primary tumor only * Cohort B: patients with a primary tumor and/or advanced/metastatic disease with a quantifiable number of lesions (6 - 14 patients)
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05784597
Sponsor's protocol ID
PH-FAPGA-01/22
Acronym
FAPrimo
Status last verified
Nov 2024
First submitted
15 Dec 2022
Last updated
15 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [68Ga]Ga-OncoFAP administration in people with Breast Cancer and Colorectal Cancer, run by Philogen S.p.A. at 5 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (AE) (time frame: Throughout study, until a maximum of 8 days after the completion of each patient). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05784597.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.

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