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Advanced Solid TumorEarly Phase 1NCT07577206

Single Microdose Trial- CXCR4 PET Tracer - Pharmacokinetics and Pharmacodynamics of [68Ga]Ga-R54, a Radiopharmaceutical Directed Toward CXCR4 in Patients With Advanced Solid Neoplasia.

A Early Phase 1 study testing [68Ga]Ga-R54 PET/CT in people with Advanced Solid Tumor and Multiple Myeloma, run by National Cancer Institute, Naples at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Phase 1, monocentric, open labeled, no profit "Microdose" trial. A single microdose of the new [68Ga]Ga-R54 PET radiopharmaceutical directed against CXCR4 will be injected into patients with advanced solid tumor or multiple myeloma to evaluate the binding. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor, Multiple Myeloma
What is being tested?
[68Ga]Ga-R54 PET/CT
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteItaly
Study dates
24 Jan 2025to Jan 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients > 18 years
  • Patients with histological diagnosis of solid neoplasm (breast, lung, colon, ovary, pancreas) in advanced stages or multiple myeloma evaluated by PET/CT with [18F]FDG carried out in the 3 months prior to enrollment. The neoplasm must express the CXCR4 receptor by immunohistochemistry
  • Patients with ECOG performance status 0-2, able to undergo the scheduled diagnostic procedure (PET/CT with [68Ga]Ga-R54).
  • Patients with alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase <3 x upper limit of reference range and total bilirubin <2.0 mg/dL
  • Patients with creatinine < 1.5 x upper limit of reference range or 24-hour creatinine clearance > 50 mL/min
  • Negative serum pregnancy test (b-hCG) for women of childbearing age before administration of [68Ga]Ga-R54).
  • Signature of informed consent indicating that the patient (or legal representative) has been informed of all aspects pertinent to the study
  • Willingness and ability to comply with scheduled visits, laboratory tests and other study procedures.

Who cannot join

  • Presence of active infections (e.g. requiring antibiotic therapy) or other serious concomitant illness, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study
  • Declared chronic active hepatitis (hepatitis B / C)
  • Declared active autoimmune diseases
  • Recovery from major trauma including surgery within 4 weeks of study enrollment
  • Presence of neurodegenerative diseases
  • Pregnancy and/or breastfeeding
  • Any conditions that in the opinion of the investigator could hinder compliance with the study protocol
  • Patients who have not signed consent to participate in the study

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Stefania Scala, M.D. contact

08117770596

s.scala@istitutotumori.na.it

Italy1 site, 1 recruiting

  • Istituto Nazionale Tumori Fondazione G. Pascale - SC Medicina Nucleare e Terapia Metabolica

    Naples, Italia, 80131

    Secondo Lastoria

    Recruiting

Other trials in Italy

About this study

Phase 1, monocentric, open labeled, no profit "Microdose" trial. A single microdose of the new [68Ga]Ga-R54 PET radiopharmaceutical directed against CXCR4 will be injected into patients with advanced solid tumor or multiple myeloma to evaluate the binding.

Read the detailed description

The present study aims to evaluate the pharmacokinetic/pharmacodynamic profile and the engagement capacity of a new PET probe that binds the CXCR4 receptor. A Microdose-Trial (Guideline ICH M3(R2) CPMP/ICH/286/95 type 1 approach and EMEA/CHMP/SWP/28367/07 Rev. 1) is proposed in order to evaluate the pharmacokinetics and pharmacodynamics of a single microdose of the radiopharmaceutical [68Ga]Ga-R54 in patients suffering from solid tumors in the advanced stage of the disease or multiple myeloma. At least 5 and no more than 10 consenting patients with advanced solid tumors (breast, lung, colon, ovary, and pancreas) or multiple myeloma will be recruited with at least 1 patient per pathology whose neoplasm expresses CXCR4. Study patients will receive i.v. a single dose of [68Ga]Ga-R54 ≤100 μg. The localization of the target will be carried out with PET/CT method. Pharmacokinetics will be analyzed by blood samples taken at 2, 5, 10, 30 minutes, 1, 2 and 4 hours post infusion. Patients will be enrolled at least 7 days apart to monitor the onset of adverse events.

Being tested
[68Ga]Ga-R54 PET/CT
Keywords
"Microdose" trial, CXCR4, [68Ga]Ga-R54 PET radiopharmaceutical, pharmacokinetics, pharmacodynamics, advanced solid neoplasia, multiple myeloma
Medical subject headings
Multiple Myeloma

What participants receive

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

  • [68Ga]Ga-R54 PET/CTDrug

    A single intravenous microdose (≤100 μg) of the CXCR4-targeting radiopharmaceutical [68Ga]Ga-R54 is administered, followed by whole-body PET/CT imaging. Serial blood samples are collected up to 4 hours post-injection to assess pharmacokinetics. Imaging is performed according to institutional standards to evaluate in vivo CXCR4 expression in tumor lesions.

Study groups in NCT07577206
Study groupRoleWhat they receive
[68Ga]Ga-R54 PET/CT scanExperimentalEligible patients with advanced or metastatic breast, pancreatic, colorectal, ovarian, lung cancer or multiple myeloma undergo screening with [18F]-FDG PET/CT and tumor CXCR4 immunohistochemical analysis on available cyto-histological material. Patients with CXCR4-positive tumors and confirmed eligibility are scheduled to undergo [68Ga]Ga-R54 PET/CT imaging within 8 days after a positive [18F]-FDG PET/CT scan. If immunohistochemical assessment is delayed beyond 8 days, a repeat [18F]-FDG PET/CT may be required to confirm eligibility before proceeding. The [68Ga]Ga-R54 PET/CT is performed according to protocol and does not interfere with planned therapeutic management. CXCR4-negative patients are considered screening failures and do not undergo investigational imaging.
Receives: Drug: [68Ga]Ga-R54 PET/CT

What is being measured

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

  1. Quantitative analysis of the uptake (pharmacodynamics) of [68Ga]Ga-R54 in the neoplastic lesion by measuring the "maximum standardized uptake value" (SUVmax).

    Measured: Single time point at PET/CT imaging (Day 1)

  2. Pharmacokinetics of the PET radiopharmaceutical [68Ga]Ga-R54 through measurement of radioactivity in blood at the gamma counter (%ID/g).

    Measured: Peri-procedural (at time of PET/CT imaging, Day 1)

Secondary outcomes (2)

  1. Evaluation of the dosimetric parameters for the tumor and for healthy organs by determining the absorbed dose per unit of activity administered (mGy/MBq).

    Measured: From time of [68Ga]Ga-R54 administration up to 4 hours post-injection

  2. SUVmax correlation of the radiopharmaceutical [68Ga]Ga-R54 and CXCR4 expression assessed by immunohistochemistry in the tumor and microenvironment.

    Measured: Single time point at PET/CT imaging (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 posted11 May 2026
  2. Study start24 Jan 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

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
Early Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07577206
Sponsor's protocol ID
R4 FOUR-PET
Other IDs
2024-513303-14-00
Status last verified
Apr 2026
First submitted
22 Apr 2026
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [68Ga]Ga-R54 PET/CT in people with Advanced Solid Tumor and Multiple Myeloma, run by National Cancer Institute, Naples at 1 site 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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Stefania Scala, M.D. (08117770596, s.scala@istitutotumori.na.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantitative analysis of the uptake (pharmacodynamics) of [68Ga]Ga-R54 in the neoplastic lesion by measuring the "maximum standardized uptake value" (SUVmax). (time frame: Single time point at PET/CT imaging (Day 1)). The study lists 2 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 NCT07577206.

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 11 May 2026.

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