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Radioisotope Therapy
Targeted Alpha-Particle Therapy for Neuroendocrine Tumors (212-Pb-VMT Trial)
Phase 1 & 2
Recruiting
Research Sponsored by Perspective Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG Performance Status 0-2
Progressive Disease on approved therapies other than radionuclide therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 hour, 4 hours and 24 hours
Awards & highlights
212-Pb-VMT Trial Summary
This trial is testing a new therapy to treat advanced neuroendocrine tumors using targeted alpha-particles.
Who is the study for?
This trial is for adults with advanced neuroendocrine tumors that show SSTR2 positivity on specific PET scans. Participants must have measurable disease progression, an ECOG Performance Status of 0-2, and a life expectancy over 3 months. Those with HIV can join if they meet certain criteria. It's not for pregnant women, those with severe recent nausea/vomiting or diarrhea, known hypersensitivity to related drugs, active secondary cancers (except stable brain metastases), or inadequate organ function.Check my eligibility
What is being tested?
[212Pb]VMT-α-NET Targeted Alpha-Particle Therapy is being tested in this Phase I/IIa study for its effectiveness against advanced SSTR2 positive neuroendocrine tumors. The therapy aims to deliver radiation directly to the cancer cells while sparing healthy tissue.See study design
What are the potential side effects?
Potential side effects may include typical reactions from targeted radiation therapies such as fatigue, nausea, vomiting, and localized pain where the tumor is located. Blood counts might be affected leading to increased risk of infections or bleeding problems.
212-Pb-VMT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of the day.
Select...
My condition worsened despite treatment, but I haven't had radionuclide therapy.
Select...
My scans show positive SSTR2 using a specific PET imaging agent.
Select...
My condition worsened despite treatment, but I haven't had radionuclide therapy.
Select...
My cancer is advanced and cannot be removed by surgery.
Select...
My cancer is advanced and cannot be removed by surgery.
Select...
My adrenaline-producing tumor is under control with medication.
Select...
I am 18 or older with a neuroendocrine tumor diagnosis.
Select...
I am an adult with a neuroendocrine tumor diagnosed by a local pathologist.
Select...
My scans show positive SSTR2 using a specific PET imaging agent.
Select...
My adrenaline-producing tumor is under control with medication.
212-Pb-VMT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 hour, 4 hours and 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour, 4 hours and 24 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the concentration-time curve (AUC) [Time Frame: 42 days following last dose of [212Pb]VMT-α-NET; up to 3 years
Number of participants with adverse events (AEs) [Time Frame: Through 42 days following last dose of [212Pb]VMT-α-NET; up to 3 years]
Number of participants with dose-limiting toxicities (DLTs) [Time Frame: Through 42 days following last dose of [212Pb]VMT-α-NET; up to 3 years]
+1 moreSecondary outcome measures
Anti-tumor efficacy of in terms of tumor response
Biodistribution of [212Pb]VMT-α-NET using a microdose of the therapeutic surrogate, [203Pb]VMT-α-NET
Determine the duration of response (DOR) receiving [212Pb]VMT-α-NET.
+1 more212-Pb-VMT Trial Design
2Treatment groups
Experimental Treatment
Group I: Dose Expansion with RPh2DExperimental Treatment1 Intervention
Up to 20 patients with NET
Group II: Dose EscalationExperimental Treatment1 Intervention
Dose Escalation to determine MTD/MFD in 32 patients receiving up to 4 administrations of [212Pb]VMT-α-NET approximately 8 weeks apart.
A dosimetry sub-study utilizing [203Pb]VMT-α-NET has been incorporated into the study.
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Who is running the clinical trial?
Perspective TherapeuticsLead Sponsor
4 Previous Clinical Trials
103 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
44 Patients Enrolled for Neuroendocrine Tumors
Viewpoint Molecular TargetingLead Sponsor
3 Previous Clinical Trials
79 Total Patients Enrolled
1 Trials studying Neuroendocrine Tumors
20 Patients Enrolled for Neuroendocrine Tumors
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had major surgery more than 30 days ago.My cancer has grown or spread in the last year, as shown by scans.You are expected to live for more than 3 months.I can take care of myself and am up and about more than half of the day.I am taking SSA for a functional tumor and it has grown despite the treatment.I have not received any live vaccines in the week before joining.My recent scans show measurable cancer according to specific criteria.My cancer has worsened in the last year according to scans.My condition worsened despite treatment, but I haven't had radionuclide therapy.My scans show positive SSTR2 using a specific PET imaging agent.My condition worsened despite treatment, but I haven't had radionuclide therapy.I am allergic to Octreotate, DOTATATE, or ingredients in [212Pb]VMT-α-NET.I have not taken antibiotics or antifungals for an infection in the last 3 days.I have another type of cancer that is currently active.Your heart takes too long to recharge between beats.Your blood tests show low levels of hemoglobin, platelets, or white blood cells, or your kidney or liver function is not normal.My brain metastases have been stable for 6 months and I haven't used steroids in the last 14 days.I can stop my long-acting somatostatin treatment for 30 days before my PET scan, if my doctor agrees.My cancer is advanced and cannot be removed by surgery.I've had severe nausea, vomiting, or diarrhea in the last 3 days despite treatment.You currently abuse alcohol or illegal drugs, except if you are using medically prescribed cannabinoids.If I have a fever, my treatment will be rescheduled for after 48 hours once the fever is gone.My cancer is advanced and cannot be removed by surgery.You can participate in the study if you have HIV, but your CD4 count needs to be higher than 500 cells/μL.I completed my 90-Ytrium radioembolization treatment over 6 months ago.I finished my external beam radiation therapy over 30 days ago.I finished my last cancer treatment 30 days ago, except for hormone therapy if I have a functional tumor.You can join the study if you have HIV, but your CD4 count must be higher than 500 cells/μL.You have had a severe allergic reaction to any of the ingredients in the investigational drug.My adrenaline-producing tumor is under control with medication.I am 18 or older with a neuroendocrine tumor diagnosis.I am an adult with a neuroendocrine tumor diagnosed by a local pathologist.My recent scans show measurable cancer.I have previously received PRRT treatments.My scans show positive SSTR2 using a specific PET imaging agent.My adrenaline-producing tumor is under control with medication.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Expansion with RPh2D
- Group 2: Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the minimum age requirement for this medical trial below 55 years?
"The age range for inclusion in this clinical trial is limited to 18 - 90. However, there are 332 studies targeting minors and 2972 trials catering to older adults."
Answered by AI
What objectives does this trial have in mind?
"This association is aiming to gather data over a 42 day period that may extend up to 3 years. The primary objective will be the number of adverse events reported, while secondary goals include assessment of tumor response rate and progression-free/overall survival with RECIST v1.1 criteria as well as imaging studies for biodistribution evaluation using [203Pb]VMT-α-NET microdoses."
Answered by AI
Are there any open spots available for the current clinical trial?
"As per the data available on clinicaltrials.gov, this trial has stopped seeking participants: it was originally published on March 31st 2023 and last updated November 23rd 2022. Despite this study having ended recruitment, there are still 3160 other medical trials recruiting patients at present."
Answered by AI
Does my profile qualify me to take part in this clinical investigation?
"Eligibility for participation in this medical trial requires that individuals possess tumor antigens and are between 18-90 years old. Currently, the team is recruiting 52 patients."
Answered by AI
Who else is applying?
What site did they apply to?
University of Kentucky
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I hoping for cancer free and believing for new trial .Im just 64 and I’m not ready to go yet.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long the screening test take ?
And how long the Trial will be ?
PatientReceived 2+ prior treatments
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