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NCT Number: NCT07781852

Evaluation of the Distribution of 64Cu/68Ga Labeled 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 PET-MR and 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.

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Key information

Conditions

Bladder Cancer Adnexal Diseases Astrocytoma Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer (GC) Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Glioblastoma Glioblastoma (GBM) Glioma Gonadal Disorders Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Cancer Kidney Diseases Kidney Neoplasms Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer (NSCLC) Lung Diseases Lung Neoplasms Male Urogenital Diseases Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Oral Cavity Cancer Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Ovarian Cancer Ovarian Diseases Ovarian Neoplasms PDAC - Pancreatic Ductal Adenocarcinoma Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Pharynx Cancer Prostate Cancer Prostatic Diseases Prostatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Stomatognathic Diseases Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Massachussetts General Hospital, Boston, Massachusetts, United States

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About this study

The primary objectives of this study are:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

[64Cu]CM500

Drug

[64Cu]CM500 is a peptide-based PET radiopharmaceutical. [64Cu]CM500 is administered intravenously (IV)

[68Ga]CM500

Drug

[68Ga]CM500 is a peptide-based PET radiopharmaceutical. [68Ga]CM500 is administered intravenously (IV)

PET/MR

Device

Whole body imaging using a PET/MR scanner

PET/CT

Device

Whole body imaging using a PET/CT scanner

Blood Collection

Procedure

A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry

Primary outcomes

  1. Complete blood count

    Time frame: 48 hours

    To model pharmacokinetics of [64Cu]CM500 and [68Ga]CM500 metabolism in healthy volunteers

  2. Standardized uptake value

    Time frame: 36 hours

    The standardized uptake value (SUV) of the tracer 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.

  3. Time activity curve

    Time frame: 36 hours

    To evaluate human dosimetry and radiation burden in healthy volunteers

Study contacts

Contact information is provided by the study sponsor or research team.

Greg Sorensen, MD

CONTACT

[email protected]

212-772-3111

Rachel Morello

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Lumina Pharmaceuticals Inc

Industry

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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