An Early Phase 1 interventional study of [64Cu]CM500 and [68Ga]CM500 in Bladder Cancer, Glioma and Glioblastoma (GBM), sponsored by Lumina Pharmaceuticals Inc. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Lumina Pharmaceuticals Inc · Early Phase 1, Interventional, and Diagnostic
Among 881 studies in Urinary Bladder Neoplasms with a site in United States — 162 open to participants now, 267 under way, 31 of them phase 3. Urinary Bladder Neoplasms · United States.
Among the 881 studies in Urinary Bladder Neoplasms with a site in United States, this one is the 385th largest by planned enrollment of the 714 interventional ones that give a count, is one of 39 that started in 2026, is one of 198 in phase 1, reaches primary completion later than 145 of the 264 other live ones, and was the 873rd registered.
1,800 studies on the registry are indexed under Urinary Bladder Neoplasms; 446 are open to participants now.
Browse Urinary Bladder Neoplasms studies →162 of the 881 studies in Urinary Bladder Neoplasms with a site in United States are open now. Recruiting first, the newest first:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Sites in United States
Ages 18+
SystImmune Inc. · Sites in United States
Ages 18+
Fred Hutchinson Cancer Center · Sites in United States
Ages 18+
Fox Chase Cancer Center · Sites in United States
Ages 18+
Dana-Farber Cancer Institute · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 336 Urinary Bladder Neoplasms studies recruiting now, 256 (76%) set no upper age limit and 22 (7%) stop at 75 or younger; 22 take children under 18; 21 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
881 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 281 · Phase 2 329 · Phase 3 88 · Phase 4 7
First in 1988; this study’s year is marked. 39 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 60 across 1,296 interventional studies indexed under Urinary Bladder Neoplasms.
Median enrollment 46 across the 714 interventional studies, 180 across the 144 observational. Of the 562 that completed or were terminated, 253 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
313 of 881 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Lumina Pharmaceuticals Inc as lead sponsor.
Lumina Pharmaceuticals Inc has 1 study filed under Urinary Bladder Neoplasms — fewer than ten, so there is no comparison to draw.
98 of the studies in Urinary Bladder Neoplasms with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06111235Phase 3CG Oncology, Inc.A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT | 2026-11 |
| NCT04658862Phase 3Janssen Research & Development, LLCA Study of TAR-200 in Combination With Cetrelimab Versus Concurrent Chemoradiotherapy in Participants With Muscle-invasive Bladder Cancer (MIBC) of the Bladder | 2026-12-30 |
| NCT06525571Phase 3Johns Hopkins UniversityOutcomes of High-risk Non-muscle Invasive Bladder Cancer Treated With Blue Light Resection | 2027-01-04 |
| NCT05911295Phase 3Seagen, a wholly owned subsidiary of PfizerDisitamab Vedotin With Pembrolizumab vs Chemotherapy in Previously Untreated Urothelial Cancer Expressing HER2 | 2027-01-29 |
| NCT04241185Phase 3Merck Sharp & Dohme LLCEfficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992) | 2027-01-31 |
Add all 98 to your calendar (.ics) → With an account.
Among the 881 studies in Urinary Bladder Neoplasms with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For healthy subjects:
For patient subjects with presence of cancer:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: [64Cu]CM500 · Device: PET/MR · Device: PET/CT · Procedure: Blood Collection
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.
Drug: [64Cu]CM500 · Device: PET/MR · Device: PET/CT · Procedure: Blood Collection
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
Drug: [68Ga]CM500 · Device: PET/MR · Device: PET/CT · Procedure: Blood Collection
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.
Drug: [68Ga]CM500 · Device: PET/MR · Device: PET/CT · Procedure: Blood Collection
\[64Cu\]CM500 is a peptide-based PET radiopharmaceutical. \[64Cu\]CM500 is administered intravenously (IV)
\[68Ga\]CM500 is a peptide-based PET radiopharmaceutical. \[68Ga\]CM500 is administered intravenously (IV)
Whole body imaging using a PET/MR scanner
Whole body imaging using a PET/CT scanner
A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry
Pharmacokinetics of the PET radiopharmaceuticals [64Cu]CM500 and [68Ga]CM500 in healthy volunteers through measurement of radioactivity in blood
Time frame: 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.
Time frame: 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.
Time frame: 36 hours
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.
Of 80 industry-sponsored phase 1 interventional studies under Urinary Bladder Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 66. This study's planned 12 months is below that.
Counting every sponsor, half of 145 studies reached it within 43 months; a quarter within 29 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gallium-68