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

August 27, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: Blood Collection
A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry
Drug: [64Cu]CM500
[64Cu]CM500 is a peptide-based PET radiopharmaceutical. [64Cu]CM500 is administered intravenously (IV)
Device: PET/MR
Whole body imaging using a PET/MR scanner
Device: PET/CT
Whole body imaging using a PET/CT scanner
Active Comparator: 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
Procedure: Blood Collection
A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry
Device: PET/MR
Whole body imaging using a PET/MR scanner
Device: PET/CT
Whole body imaging using a PET/CT scanner
Drug: [68Ga]CM500
[68Ga]CM500 is a peptide-based PET radiopharmaceutical. [68Ga]CM500 is administered intravenously (IV)
Experimental: 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.
Procedure: Blood Collection
A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry
Device: PET/MR
Whole body imaging using a PET/MR scanner
Device: PET/CT
Whole body imaging using a PET/CT scanner
Drug: [68Ga]CM500
[68Ga]CM500 is a peptide-based PET radiopharmaceutical. [68Ga]CM500 is administered intravenously (IV)
Active Comparator: 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.
Procedure: Blood Collection
A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry
Drug: [64Cu]CM500
[64Cu]CM500 is a peptide-based PET radiopharmaceutical. [64Cu]CM500 is administered intravenously (IV)
Device: PET/MR
Whole body imaging using a PET/MR scanner
Device: PET/CT
Whole body imaging using a PET/CT scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of the PET radiopharmaceuticals [64Cu]CM500 and [68Ga]CM500 in healthy volunteers through measurement of radioactivity in blood
Time Frame: 48 hours
48 hours
Standardized uptake value
Time Frame: 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
Time Frame: 36 hours
Organs assessed include, but are not limited to, the heart, liver, spleen, kidney, and urinary bladder.
36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lumina Pharmaceuticals Inc

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

August 19, 2026

First Submitted That Met QC Criteria

August 19, 2026

First Posted (Actual)

August 24, 2026

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP-2025-1
  • 5R44CA275590-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe