Glioblastoma Multiforme (GBM)Phase 1RMX-VHNCT07733674
Study of 203Pb-RMX-VH-PIB Dosimetry and Biodistribution in Patients With Glioblastoma Multiform (GBM) and Pancreatic Ductal Adenocarcinoma (PDAC)
A Phase 1 study testing 203Pb-RMX-VHPIB injection and SPECT/CT Imaging in people with Glioblastoma Multiforme (GBM) and Pancreatic Ductal Adenocarcinoma (PDAC), run by Radiomedix, Inc. at 1 site in United States.
Trial summary
The goal of this Phase I clinical trial is to evaluate how the imaging drug 203Pb- RMX-VH-PIB distributes in the body and how much radiation different organs receive in patients with glioblastoma multiforme (GBM) or pancreatic ductal adenocarcinoma (PDAC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme (GBM), Pancreatic Ductal Adenocarcinoma (PDAC)
- What is being tested?
- 203Pb-RMX-VHPIB injection and SPECT/CT Imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2026to 30 Jun 2027
- Phase
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Subjects aged ≥18 years.
- Karnofsky status ≥60.
- Negative urine pregnancy test in women of childbearing potential.
- Histologically confirmed and /or highly suspicious GBM (Adult type Astrocytoma grade IV both IDH-Mutant and IDH-Wild Type) including primary, recurrent or stable enhancing residual or primary, recurrent or stable enhancing residual PDAC.
- GBM group i. Contrast enhanced Brain MRI image with results compatible with GBM within the 2 weeks of dosing day.
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- Tumor size of ≥ 1.0 cm in any dimension by MRI. iii. No antiangiogenic therapy within 4 weeks of the day of dosing. iv. No chemotherapy within 2 weeks of the day of dosing. v. Subjects receiving corticosteroids must be on a stable or decreasing dose regimen prior to enrollment b. PDAC group i. No chemotherapy within 2 weeks of the day of dosing ii. Tumor size of ≥ 1.0 cm in any dimension by MRI or CT
- Recent blood test results (within 4 weeks pre-dose) as follows:
- WBC: ≥ 2 x 109/L
- Haemoglobin: ≥ 8 g/dL
- Platelets: ≥75 x 109/L
- ALT, AST, AP ≤ 5 times ULN
- Bilirubin: ≤ 2 times ULN
- Creatinine clearance ≥ 60 mL/min, calculated by the Cockcroft-Gault equation
Who cannot join
- Known hypersensitivity to RMX-VH peptide analogue, 203Pb-RMX-VH-PIB, 203Pb (Lead) , or any of the excipients of 203Pb-RMX-VH-PIB.
- Inability to undergo MRI or CT/SPECT/CT scans
- Current somatic or psychiatric disease/condition that may interfere with consent or the objectives and assessments of the study.
- Pregnancy or plans to conceive during the course of study participation.
- In GBM groups participants requiring MRI: History of hypersensitivity or contraindication to gadolinium-based contrast agents, including prior allergic or anaphylactoid reactions to gadolinium contrast media, or any condition (e.g., severe renal impairment, acute kidney injury) that, in the investigator's judgment, increases the risk associated with gadolinium administration.
- In PDAC groups participants requiring CT scans: Any contraindications to iodinated contrast agents include a history of severe hypersensitivity or allergic reaction to iodinated contrast media, significant renal impairment (e.g., eGFR < 30 mL/min/1.73 m² or acute kidney injury), uncontrolled hyperthyroidism or other thyroid disorders that may worsen with iodine exposure, prior contrast-induced nephropathy, pregnancy, and any unstable medical condition such as severe heart failure or hemodynamic instability that, in the investigator's judgment, increases the risk of contrast administration.
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- Male and female participants of childbearing potential who are unwilling or unable to use an acceptable method of contraception for the duration of the study.
- Women who are breastfeeding
- Participants who are currently receiving treatment with statins (HMG-CoA reductase inhibitors), including but not limited to atorvastatin, rosuvastatin, pitavastatin, simvastatin, lovastatin, pravastatin, or fluvastatin, are excluded unless the medication has been discontinued for at least four (4) drug half-lives prior to administration of the investigational product
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Excel Diagnostics & Nuclear Oncology Center
Houston, Texas, 77042
Susan Cork, 713-781-6200 ext. 3203, scork@exceldiagnostics.com
Nereyda Sauceda Sauceda, 713-781-6200 ext. 3246, nsauceda@exceldiagnostics.com
About this study
Official title: Dosimetry and Bio-distribution of 203Pb-RMX-VH-PIB in Newly Diagnosed or Recurrent Patients With Solid Tumors: A Phase I Exploratory Study
The goal of this Phase I clinical trial is to evaluate how the imaging drug 203Pb- RMX-VH-PIB distributes in the body and how much radiation different organs receive in patients with glioblastoma multiforme (GBM) or pancreatic ductal adenocarcinoma (PDAC).
The main questions it aims to answer are:
Read more
How does 203Pb-RMX-VH-PIB spread in the body (biodistribution)? What is the radiation dose delivered to organs (dosimetry)?
Participants will:
Receive a single intravenous (IV) injection of 203Pb-RMX-VH-PIB. Undergo multiple single-photon emission computed tomography/computed tomography (SPECT/CT) imaging scans.
Have blood, urine, vital signs, and electrocardiogram (ECG) monitored for safety.
Be followed for any side effects for up to 30 days.
Read the detailed description
This is an early-stage clinical trial designed to test a new imaging drug called 203Pb-RMX-VH-PIB. The study will use SPECT/CT scans to see how the drug spreads through the body and how much radiation is delivered to different organs. The trial will enroll 20 patients who have either glioblastoma multiforme (GBM), an aggressive brain tumor, or pancreatic ductal adenocarcinoma (PDAC), a type of pancreatic cancer. Patients may be newly diagnosed, have recurrent disease, or have stable tumors. For GBM patients, the drug's distribution will be compared with MRI scans to see if it highlights the tumor areas effectively. For PDAC patients, the study will track how the drug behaves in pancreatic tumors. Participants will be divided into four groups to study both biodistribution and dosimetry in each cancer type. Each participant will receive a single intravenous injection of the drug, followed by several whole-body SPECT/CT scans. To ensure safety, vital signs will be measured before and after the injection, and blood and urine samples will be collected at multiple time points. A 12-lead ECG will also be performed to monitor heart rhythm, and results will be reviewed by the investigator. Any side effects or health changes will be closely monitored and recorded for 30 days after administration. The goal of this exploratory study is to better understand how 203Pb-RMXVH- PIB works in the body and to gather important safety and radiation data in patients with GBM and PDAC.
- Being tested
- 203Pb-RMX-VHPIB injection, SPECT/CT Imaging
- Keywords
- Glioblastoma Multiforme (GBM), Pancreatic Ductal Adenocarcinoma (PDAC), 203Pb-RMX-VH-PIB, SPECT/CT Imaging, Radiopharmaceutical, Brain Tumor, Pancreatic Cancer, RMX-VH-02, lead-203, radiolabeled peptide, investigational radiopharmaceutical, diagnostic radiopharmaceutical, tumor-targeted radiopharmaceutical, malignant glioma, high-grade glioma, malignant brain tumor, astrocytoma, IDH-wildtype glioblastoma, brain tumor targeting, Astrocytoma grad IV
- Medical subject headings
- Glioblastoma, Brain Neoplasms, Pancreatic Neoplasms, Glioma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
203Pb-RMX-VHPIB injectionDrug
Also called Radiotracer Injection
A single intravenous (IV) injection of the investigational radiopharmaceutical 203Pb-RMX-VHPIB administered to eligible patients.
SPECT/CT ImagingDiagnostic test
Also called Single-Photon Emission Computed Tomography/Computed Tomography Imaging
Serial whole-body and region-specific SPECT/CT scans performed after IP administration to assess biodistribution and dosimetry
| Study group | Role | What they receive |
|---|---|---|
| 203Pb-RMX-VH-PIB Imaging | Experimental | All participants will receive a single intravenous injection of 203Pb-RMX-VH-PIB (5.0 ± 10% mCi). Following administration, participants will undergo multiple SPECT/CT scans to evaluate the biodistribution and radiation dosimetry of the investigational radiopharmaceutical. Safety assessments will include monitoring of vital signs, blood exams, and electrocardiograms (ECGs) before and after dosing, with adverse events recorded for up to 30 days. Receives: Drug: 203Pb-RMX-VHPIB injection; Diagnostic Test: SPECT/CT Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body and organ-specific absorbed radiation dose for 203Pb-RMX-VH-PIB
Whole-body and organ-specific absorbed radiation doses will be estimated using serial quantitative SPECT/CT imaging and available blood and urine radioactivity data following a single intravenous administration of 203Pb-RMX-VH-PIB. Absorbed radiation doses will be summarized per unit of administered activity, such as mGy/MBq.
Measured: From injection to up to 144 hours post-injection, multi-time-point SPECT/CT, approximately 1-2 hours, 4-6 hours, 24 hours, 48 hours, 120 hours, and, if needed, 144 hours after injection.
Organ-Specific Absorbed Dose of 203Pb-RMX-VH-PIB
For each participant, volumes of interest (VOIs) will be delineated over critical organs, including the kidneys, liver, spleen, red marrow, pancreas, brain, thyroid, and salivary glands, as well as target lesions. Time-activity curves will be fitted, and residence times will be derived. The absorbed dose per unit of injected activity will be calculated using the standard Medical Internal Radiation Dose (MIRD) schema with Organ Level Internal Dose Assessment/Exponential Modeling (OLINDA/EXM) software or an equivalent method.
Measured: From injection to up to144 hours post-injection, multi-time-point SPECT/CT, approximately 1-2 hours, 4-6 hours, 24 hours, 48 hours, 120 hours, and, if needed, 144 hours after injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start15 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma Multiforme (GBM)Studies 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single group, open-label study in which all participants with glioblastoma multiforme (GBM) or pancreatic ductal adenocarcinoma (PDAC) will receive a single intravenous dose of 203Pb-RMX-VH-PIB. Participants will then undergo multiple SPECT/CT scans to evaluate biodistribution and dosimetry. Sub-groups (GBM vs PDAC; biodistribution vs dosimetry) are used for analysis purposes only, but all participants receive the same intervention.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radiomedix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ebrahim Delpassand, MD, FACNM, Study chair, Radiomedix, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733674
- Sponsor's protocol ID
- RMX-VH-02
- Acronym
- RMX-VH
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosimetry and Bio-distribution of 203Pb-RMX-VH-PIB in Newly Diagnosed or Recurrent Patients With Solid Tumors: A Phase I Exploratory Study
- ClinicalTrials.gov ID
- NCT07733674
- Acronym / sponsor ID
- RMX-VH / RMX-VH-02
- Keywords
- Glioblastoma Multiforme (GBM), Pancreatic Ductal Adenocarcinoma (PDAC), 203Pb-RMX-VH-PIB, SPECT/CT Imaging, Radiopharmaceutical, Brain Tumor, Pancreatic Cancer, RMX-VH-02
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Radiomedix, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this Phase I clinical trial is to evaluate how the imaging drug 203Pb- RMX-VH-PIB distributes in the body and how much radiation different organs receive in patients with glioblastoma multiforme (GBM) or pancreatic ductal adenocarcinoma (PDAC).
The main questions it aims to answer are:
How does 203Pb-RMX-VH-PIB spread in the body (biodistribution)? What is the radiation dose delivered to organs (dosimetry)?
Participants will:
Receive a single intravenous (IV) injection of 203Pb-RMX-VH-PIB. Undergo multiple single-photon emission computed tomography/computed tomography (SPECT/CT) imaging scans.
Have blood, urine, vital signs, and electrocardiogram (ECG) monitored for safety.
Be followed for any side effects for up to 30 days.
Detailed description
This is an early-stage clinical trial designed to test a new imaging drug called 203Pb-RMX-VH-PIB. The study will use SPECT/CT scans to see how the drug spreads through the body and how much radiation is delivered to different organs. The trial will enroll 20 patients who have either glioblastoma multiforme (GBM), an aggressive brain tumor, or pancreatic ductal adenocarcinoma (PDAC), a type of pancreatic cancer. Patients may be newly diagnosed, have recurrent disease, or have stable tumors. For GBM patients, the drug's distribution will be compared with MRI scans to see if it highlights the tumor areas effectively. For PDAC patients, the study will track how the drug behaves in pancreatic tumors. Participants will be divided into four groups to study both biodistribution and dosimetry in each cancer type. Each participant will receive a single intravenous injection of the drug, followed by several whole-body SPECT/CT scans. To ensure safety, vital signs will be measured before and after the injection, and blood and urine samples will be collected at multiple time points. A 12-lead ECG will also be performed to monitor heart rhythm, and results will be reviewed by the investigator. Any side effects or health changes will be closely monitored and recorded for 30 days after administration. The goal of this exploratory study is to better understand how 203Pb-RMXVH- PIB works in the body and to gather important safety and radiation data in patients with GBM and PDAC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single group, open-label study in which all participants with glioblastoma multiforme (GBM) or pancreatic ductal adenocarcinoma (PDAC) will receive a single intravenous dose of 203Pb-RMX-VH-PIB. Participants will then undergo multiple SPECT/CT scans to evaluate biodistribution and dosimetry. Sub-groups (GBM vs PDAC; biodistribution vs dosimetry) are used for analysis purposes only, but all participants receive the same intervention.
| Arm | Type | Receives |
|---|---|---|
| 203Pb-RMX-VH-PIB Imaging | Experimental | Drug: 203Pb-RMX-VHPIB injection, Diagnostic Test: SPECT/CT ImagingAll participants will receive a single intravenous injection of 203Pb-RMX-VH-PIB (5.0 ± 10% mCi). Following administration, participants will undergo multiple SPECT/CT scans to evaluate the biodistribution and radiation dosimetry of the investigational radiopharmaceutical. Safety assessments will include monitoring of vital signs, blood exams, and electrocardiograms (ECGs) before and after dosing, with adverse events recorded for up to 30 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed informed consent.
- Subjects aged ≥18 years.
- Karnofsky status ≥60.
- Negative urine pregnancy test in women of childbearing potential.
- Histologically confirmed and /or highly suspicious GBM (Adult type Astrocytoma grade IV both IDH-Mutant and IDH-Wild Type) including primary, recurrent or stable enhancing residual or primary, recurrent or stable enhancing residual PDAC.
Key exclusion criteria (9 listed)
- Known hypersensitivity to RMX-VH peptide analogue, 203Pb-RMX-VH-PIB, 203Pb (Lead) , or any of the excipients of 203Pb-RMX-VH-PIB.
- Inability to undergo MRI or CT/SPECT/CT scans
- Current somatic or psychiatric disease/condition that may interfere with consent or the objectives and assessments of the study.
- Pregnancy or plans to conceive during the course of study participation.
- In GBM groups participants requiring MRI: History of hypersensitivity or contraindication to gadolinium-based contrast agents, including prior allergic or anaphylactoid reactions to gadolinium contrast media, or any condition (e.g., severe renal impairment, acute kidney injury) that, in the investigator's judgment, increases the risk associated with gadolinium administration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 203Pb-RMX-VHPIB injectionAlso: Radiotracer InjectionA single intravenous (IV) injection of the investigational radiopharmaceutical 203Pb-RMX-VHPIB administered to eligible patients. | Drug | 203Pb-RMX-VH-PIB Imaging |
| SPECT/CT ImagingAlso: Single-Photon Emission Computed Tomography/Computed Tomography ImagingSerial whole-body and region-specific SPECT/CT scans performed after IP administration to assess biodistribution and dosimetry | Diagnostic test | 203Pb-RMX-VH-PIB Imaging |
Primary outcome
Whole-body and organ-specific absorbed radiation dose for 203Pb-RMX-VH-PIB
Time frame: From injection to up to 144 hours post-injection, multi-time-point SPECT/CT, approximately 1-2 hours, 4-6 hours, 24 hours, 48 hours, 120 hours, and, if needed, 144 hours after injection.
Whole-body and organ-specific absorbed radiation doses will be estimated using serial quantitative SPECT/CT imaging and available blood and urine radioactivity data following a single intravenous administration of 203Pb-RMX-VH-PIB. Absorbed radiation doses will be summarized per unit of administered activity, such as mGy/MBq.
Organ-Specific Absorbed Dose of 203Pb-RMX-VH-PIB
Time frame: From injection to up to144 hours post-injection, multi-time-point SPECT/CT, approximately 1-2 hours, 4-6 hours, 24 hours, 48 hours, 120 hours, and, if needed, 144 hours after injection.
For each participant, volumes of interest (VOIs) will be delineated over critical organs, including the kidneys, liver, spleen, red marrow, pancreas, brain, thyroid, and salivary glands, as well as target lesions. Time-activity curves will be fitted, and residence times will be derived. The absorbed dose per unit of injected activity will be calculated using the standard Medical Internal Radiation Dose (MIRD) schema with Organ Level Internal Dose Assessment/Exponential Modeling (OLINDA/EXM) software or an equivalent method.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ebrahim Delpassand, MD, FACNM study chair
Radiomedix, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 203Pb-RMX-VHPIB injection and SPECT/CT Imaging in people with Glioblastoma Multiforme (GBM) and Pancreatic Ductal Adenocarcinoma (PDAC), run by Radiomedix, Inc. at 1 site 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 14 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 7 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 1 site 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Ebrahim Delpassand, MD, FACNM (713-499-9733, edelpassand@radiomedix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole-body and organ-specific absorbed radiation dose for 203Pb-RMX-VH-PIB (time frame: From injection to up to 144 hours post-injection, multi-time-point SPECT/CT, approximately 1-2 hours, 4-6 hours, 24 hours, 48 hours, 120 hours, and, if needed, 144 hours after injection.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.