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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Lumina Pharmaceuticals Inc
Study ID
NCT07781852
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • [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

Study Details

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.

Key Dates

First listed
Aug 24, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Sep 1, 2027
Completion
Sep 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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 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.
  • 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.
  • 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
  • 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.

Primary Outcome Measure

Complete blood count [ Time Frame: 48 hours ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Massachussetts General HospitalBostonMassachusetts02114
Onofrio Catalano, MD, PhD
[email protected]
617-216-5805
Diandrea GALLOWAY
[email protected]
BAMF HealthGrand RapidsMichigan49503
Research coordinator
[email protected]
616-330-2735
East River Medical ImagingNew YorkNew York10021
Research Coordinator
[email protected]
646-312-6959

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