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

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.

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.

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).