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Evaluation of the Distribution of 64Cu/68Ga Labeled CM500 in Healthy Volunteers and Patients With Cancer

27. august 2026 oppdatert av: Lumina Pharmaceuticals Inc

Evaluation of the Distribution of CM500 in Healthy Volunteers and Patients With Cancer

The objective of this study is to assess two novel positron emission tomography (PET) radiotracers, [64Cu]CM500 and [68Ga]CM500, for Positron Emission Tomography-Magnetic Resonance Imaging (PET-MR) and Positron Emission Tomography / Computed Tomography (PET-CT) imaging of solid tumors. These tracers have the potential to detect solid tumors throughout the body and may enable doctors to identify smaller tumors than conventional imaging techniques.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The primary objectives of this study are:

  1. To evaluate the safety of [64Cu]CM500 and [68Ga]CM500 and their whole-body distribution, metabolism, pharmacokinetics, and radiation burden in healthy volunteers.
  2. To measure the distribution of [64Cu]CM500 and [68Ga]CM500 PET in patients with different types of cancer.

Studietype

Intervensjonell

Registrering (Antatt)

40

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

Studer Kontakt Backup

Studiesteder

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

Ja

Beskrivelse

Inclusion Criteria:

  • For healthy subjects:

    • 18 years of age or older;
    • Deemed healthy at screening visit based on the following assessments: physical examination, height and weight, medical history, and blood pressure, pulse, temperature, pulse oximetry, heart rhythm, and respiratory rate. labs within the previous month can be utilized to determine eligibility;
    • No known history of atrial fibrillation with CHA₂DS₂-VASc score of 1 or higher, or history of thrombosis;
    • Negative drug screen;
    • Have the ability to give written informed consent.

  • For patient subjects with presence of cancer:

    • Known solid tumor cancer at any stage
    • 18 years of age or older
    • Ability to give written informed consent

Exclusion Criteria:

  • Less than 18 years of age;
  • Electrical implants such as cardiac pacemaker or perfusion pumps (MR-PET only);
  • Pregnant or breastfeeding (a negative STAT quantitative serum or urinary hCG pregnancy test is required for females having child-bearing potential before the subject can participate);
  • Claustrophobic reactions;
  • Subjects will be excluded if research-related radiation exposure exceeds current local institutional guidelines (i.e. 50 mSv in the prior 12 months);
  • Unable to lie comfortably on a bed inside a PET scanner;
  • Body weight over the weight limit for the moving table (> 300 lbs for the MRI table and >441 lbs for the CT table);
  • Metallic or electric implants contraindicated for MR-PET scanning when applicable (that is, if MRI is anticipated to be used as part of the study); such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing;
  • Diagnosis of the following conditions: acute respiratory distress syndrome (ARDS), systemic sclerosis, rheumatoid arthritis (unless disease activity is well-controlled with medication), or chronic obstructive pulmonary disease (COPD) unless COPD is managed on room air and subject can tolerate laying on a scanner;
  • Participation in another clinical study or therapeutic clinical trial in the past 30 days;
  • Under treatment of chemotherapy that would alter blood tests. Other anti-cancer medications while enrolling to trial (RLT, immunotherapy, targeted therapy) also apply to this exclusion criteria. A patient can be enrolled if the investigator determines the labs are stable between anti-cancer treatment cycles;
  • Moderate to severe renal impairment; must meet requirement of minimum eGFR of 60 mL/min/1.73 m²
  • Moderate to severe hepatic impairment; must meet requirements of bilirubin ≤1.5 times the upper limit of normal (ULN), and AST/ALT ≤3 times ULN (or ≤5 times ULN with liver metastases)
  • Baseline QTc interval ≥ 450 msec (healthy participants) or ≥ 470 msec (patients)
  • Unable to give written informed consent;
  • Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures).

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: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cancer patients [64Cu]CM500
Up to thirty-four (34) cancer patients will be injected with [64Cu]CM500 and then undergo PET/CT or PET/MR. Patient subjects will undergo blood collection before and after the scan.
Fremgangsmåte: Blodsamling
Totalt 9 cc blodprøver før, under og etter avbildning for klinisk kjemi
Legemiddel: [64Cu]CM500
[64Cu]CM500 is a peptide-based PET radiopharmaceutical. [64Cu]CM500 is administered intravenously (IV)
Enhet: PET/MR
Whole body imaging using a PET/MR scanner
Enhet: PET/CT
Whole body imaging using a PET/CT scanner
Aktiv komparator: Healthy volunteers [68Ga]CM500
Up to six (6) healthy adult subjects will be injected with [68Ga]CM500 to establish the safety, whole body distribution, metabolism, pharmacokinetics, and radiation burden of the probe. All subjects will be imaged using PET/MR or PET/CT. Healthy subjects will undergo blood collection before, during, and after the scan. An interim review of the data will be conducted after the first three subjects receive the study agent and complete all safety assessments
Fremgangsmåte: Blodsamling
Totalt 9 cc blodprøver før, under og etter avbildning for klinisk kjemi
Enhet: PET/MR
Whole body imaging using a PET/MR scanner
Enhet: PET/CT
Whole body imaging using a PET/CT scanner
Legemiddel: [68Ga]CM500
[68Ga]CM500 is a peptide-based PET radiopharmaceutical. [68Ga]CM500 is administered intravenously (IV)
Eksperimentell: Cancer patients [68Ga]CM500
Up to thirty-four (34) cancer patients will be injected with [68Ga]CM500 and then undergo PET/CT or PET/MR. Patient subjects will undergo blood collection before and after the scan.
Fremgangsmåte: Blodsamling
Totalt 9 cc blodprøver før, under og etter avbildning for klinisk kjemi
Enhet: PET/MR
Whole body imaging using a PET/MR scanner
Enhet: PET/CT
Whole body imaging using a PET/CT scanner
Legemiddel: [68Ga]CM500
[68Ga]CM500 is a peptide-based PET radiopharmaceutical. [68Ga]CM500 is administered intravenously (IV)
Aktiv komparator: Healthy Volunteers [64Cu]CM500
Up to six (6) healthy adult subjects will be injected with [64Cu]CM500 to establish the safety, whole body distribution, metabolism, pharmacokinetics, and radiation burden of the probe. All subjects will be imaged using Positron Emission Tomography-Magnetic Resonance Imaging (PET/MR) or Positron Emission Tomography / Computed Tomography (PET/CT). Healthy subjects will undergo blood collection before, during, and after the scan. An interim review of the data will be conducted after the first three subjects receive the study agent and complete all safety assessments.
Fremgangsmåte: Blodsamling
Totalt 9 cc blodprøver før, under og etter avbildning for klinisk kjemi
Legemiddel: [64Cu]CM500
[64Cu]CM500 is a peptide-based PET radiopharmaceutical. [64Cu]CM500 is administered intravenously (IV)
Enhet: PET/MR
Whole body imaging using a PET/MR scanner
Enhet: PET/CT
Whole body imaging using a PET/CT scanner

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pharmacokinetics of the PET radiopharmaceuticals [64Cu]CM500 and [68Ga]CM500 in healthy volunteers through measurement of radioactivity in blood
Tidsramme: 48 hours
48 hours
Standardized uptake value
Tidsramme: 36 hours
The standardized uptake value (SUV) of [64Cu]CM500 and [68Ga]CM500 in solid tumors and in the various organs of interest (heart, liver, spleen, kidney, lung and any other organ that exhibits uptake) will be collected.
36 hours
Dosimetry and radiation burden of [64Cu]CM500 and [68Ga]CM500
Tidsramme: 36 hours
Organs assessed include, but are not limited to, the heart, liver, spleen, kidney, and urinary bladder.
36 hours

Samarbeidspartnere og etterforskere

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

Sponsor

Lumina Pharmaceuticals Inc

Samarbeidspartnere

National Cancer Institute (NCI)

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 (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. september 2027

Studiet fullført (Antatt)

1. september 2027

Datoer for studieregistrering

Først innsendt

19. august 2026

Først innsendt som oppfylte QC-kriteriene

19. august 2026

Først lagt ut (Faktiske)

24. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • LP-2025-1
  • 5R44CA275590-03 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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