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Bladder CancerEarly Phase 1NCT07781852

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

A Early Phase 1 study testing [64Cu]CM500, [68Ga]CM500 and PET/MR in people with Bladder Cancer and Glioma, run by Lumina Pharmaceuticals Inc at 3 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Bladder Cancer, Glioma, Glioblastoma (GBM)
What is being tested?
[64Cu]CM500, [68Ga]CM500 and PET/MR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesUnited States
Study dates
1 Sep 2026to 1 Sep 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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;
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  • 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).

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Greg Sorensen, MD contact

212-772-3111

info@luminapharma.com

Rachel Morello contact

rachel@luminapharma.com

United States3 sites

  • Massachussetts General Hospital

    Boston, Massachusetts, 02114

    Onofrio Catalano, MD, PhD, 617-216-5805, OCATALANO@MGH.HARVARD.EDU

    Diandrea GALLOWAY, DGALLOWAY@mgh.harvard.edu

  • BAMF Health

    Grand Rapids, Michigan, 49503

    Research coordinator, 616-330-2735, ResearchClinicalTeam@bamfhealth.com

  • East River Medical Imaging

    New York, New York, 10021

    Research Coordinator, 646-312-6959, research@eastriverimaging.com

Other trials in United States

About this study

Official title: 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.

Read the 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.
Being tested
[64Cu]CM500, [68Ga]CM500, PET/MR, PET/CT, Blood Collection
Keywords
Cancer, Solid Tumor
Medical subject headings
Urinary Bladder Neoplasms, Glioma, Glioblastoma, Breast Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Pharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [64Cu]CM500Drug

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

  • [68Ga]CM500Drug

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

  • PET/MRDevice

    Whole body imaging using a PET/MR scanner

  • PET/CTDevice

    Whole body imaging using a PET/CT scanner

  • Blood CollectionProcedure or surgery

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

Study groups in NCT07781852
Study groupRoleWhat they receive
Healthy Volunteers [64Cu]CM500Active comparatorUp 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.
Receives: Drug: [64Cu]CM500; Device: PET/MR; Device: PET/CT; Procedure: Blood Collection
Cancer patients [64Cu]CM500ExperimentalUp 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.
Receives: Drug: [64Cu]CM500; Device: PET/MR; Device: PET/CT; Procedure: Blood Collection
Healthy volunteers [68Ga]CM500Active comparatorUp 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
Receives: Drug: [68Ga]CM500; Device: PET/MR; Device: PET/CT; Procedure: Blood Collection
Cancer patients [68Ga]CM500ExperimentalUp 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.
Receives: Drug: [68Ga]CM500; Device: PET/MR; Device: PET/CT; Procedure: Blood Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics of the PET radiopharmaceuticals [64Cu]CM500 and [68Ga]CM500 in healthy volunteers through measurement of radioactivity in blood

    Measured: 48 hours

  2. Standardized uptake value

    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.

    Measured: 36 hours

  3. Dosimetry and radiation burden of [64Cu]CM500 and [68Ga]CM500

    Organs assessed include, but are not limited to, the heart, liver, spleen, kidney, and urinary bladder.

    Measured: 36 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07781852
Sponsor's protocol ID
LP-2025-1
Other IDs
5R44CA275590-03
Status last verified
Aug 2026
First submitted
19 Aug 2026
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [64Cu]CM500, [68Ga]CM500 and PET/MR in people with Bladder Cancer and Glioma, run by Lumina Pharmaceuticals Inc at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Greg Sorensen, MD (212-772-3111, info@luminapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics of the PET radiopharmaceuticals [64Cu]CM500 and [68Ga]CM500 in healthy volunteers through measurement of radioactivity in blood (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07781852.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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