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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 maj 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

10

Fas

  • Tidig fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Italien
    • Italia
      • Naples, Italia, Italien, 80131
        • Rekrytering
        • Istituto Nazionale Tumori Fondazione G. Pascale - SC Medicina Nucleare e Terapia Metabolica
        • Kontakt:
          • Secondo Lastoria

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Diagnostisk
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: [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.
Läkemedel: [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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Quantitative analysis of the uptake (pharmacodynamics) of [68Ga]Ga-R54 in the neoplastic lesion by measuring the "maximum standardized uptake value" (SUVmax).
Tidsram: 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).
Tidsram: Peri-procedural (at time of PET/CT imaging, Day 1)
Peri-procedural (at time of PET/CT imaging, Day 1)

Sekundära resultatmått

Resultatmått
Tidsram
Evaluation of the dosimetric parameters for the tumor and for healthy organs by determining the absorbed dose per unit of activity administered (mGy/MBq).
Tidsram: 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.
Tidsram: Single time point at PET/CT imaging (Day 1)
Single time point at PET/CT imaging (Day 1)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

National Cancer Institute, Naples

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 januari 2025

Primärt slutförande (Beräknad)

1 januari 2027

Avslutad studie (Beräknad)

1 januari 2027

Studieregistreringsdatum

Först inskickad

22 april 2026

Först inskickad som uppfyllde QC-kriterierna

5 maj 2026

Första postat (Faktisk)

11 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

5 maj 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

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Nej

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