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

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Trial summary

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
Type of treatment: Injection or infusion, Medical device, Surgery or procedure
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

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:

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.

Conditions: Bladder Cancer, Glioma, Glioblastoma (GBM), Breast Cancer, Colorectal Cancer, Esophageal 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 group	Role	What they receive
Healthy Volunteers [64Cu]CM500	Active comparator	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. Receives: Drug: [64Cu]CM500; Device: PET/MR; Device: PET/CT; Procedure: Blood Collection
Cancer patients [64Cu]CM500	Experimental	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. Receives: Drug: [64Cu]CM500; Device: PET/MR; Device: PET/CT; Procedure: Blood Collection
Healthy volunteers [68Ga]CM500	Active comparator	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 Receives: Drug: [68Ga]CM500; Device: PET/MR; Device: PET/CT; Procedure: Blood Collection
Cancer patients [68Ga]CM500	Experimental	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. 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.

Pharmacokinetics of the PET radiopharmaceuticals [64Cu]CM500 and [68Ga]CM500 in healthy volunteers through measurement of radioactivity in blood
Measured: 48 hours
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
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 Sep 20261 Sep 2027

First posted24 Aug 2026
Study start1 Sep 2026 (estimated)
Primary completion1 Sep 2027 (estimated)
Study completion1 Sep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bladder CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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

Interested in taking part?

Greg Sorensen, MD

212-772-3111

info@luminapharma.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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