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

5. mai 2026 oppdatert av: National Cancer Institute, Naples
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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

10

Fase

  • Tidlig fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Italia
    • Italia
      • Naples, Italia, Italia, 80131
        • Rekruttering
        • Istituto Nazionale Tumori Fondazione G. Pascale - SC Medicina Nucleare e Terapia Metabolica
        • Ta kontakt med:
          • Secondo Lastoria

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: [68Ga]Ga-R54 PET/CT scan
Eligible 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.
Legemiddel: [68Ga]Ga-R54 PET/CT
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Quantitative analysis of the uptake (pharmacodynamics) of [68Ga]Ga-R54 in the neoplastic lesion by measuring the "maximum standardized uptake value" (SUVmax).
Tidsramme: Single time point at PET/CT imaging (Day 1)
Single time point at PET/CT imaging (Day 1)
Pharmacokinetics of the PET radiopharmaceutical [68Ga]Ga-R54 through measurement of radioactivity in blood at the gamma counter (%ID/g).
Tidsramme: Peri-procedural (at time of PET/CT imaging, Day 1)
Peri-procedural (at time of PET/CT imaging, Day 1)

Sekundære resultatmål

Resultatmål
Tidsramme
Evaluation of the dosimetric parameters for the tumor and for healthy organs by determining the absorbed dose per unit of activity administered (mGy/MBq).
Tidsramme: From time of [68Ga]Ga-R54 administration up to 4 hours post-injection
From time of [68Ga]Ga-R54 administration up to 4 hours post-injection
SUVmax correlation of the radiopharmaceutical [68Ga]Ga-R54 and CXCR4 expression assessed by immunohistochemistry in the tumor and microenvironment.
Tidsramme: Single time point at PET/CT imaging (Day 1)
Single time point at PET/CT imaging (Day 1)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Cancer Institute, Naples

Etterforskere

  • Studieleder: Stefania Scala, M.D., Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
  • Hovedetterforsker: Secondo Lastoria, M.D., Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. januar 2025

Primær fullføring (Antatt)

1. januar 2027

Studiet fullført (Antatt)

1. januar 2027

Datoer for studieregistrering

Først innsendt

22. april 2026

Først innsendt som oppfylte QC-kriteriene

5. mai 2026

Først lagt ut (Faktiske)

11. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. mai 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • R4 FOUR-PET
  • 2024-513303-14-00 (Ctis)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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