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New treatment option for Neuroendocrine Tumors Unresectable
Official title Targeted Alpha-Particle Therapy for Advanced Somatostatin Receptor Type 2 (SSTR2) Positive Tumors
ClinicalTrials.gov ID: NCT05636618
What this study is testing
What is [203Pb]VMT-α-NET?
[203Pb]VMT-α-NET is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuroendocrine tumors unresectable.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is Phase I/IIa First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Tumors
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- Adult (ages ≥18) PRRT-naïve people with NETs or meningioma by local pathology.
- Disease described clinically as: (a) Locally advanced/unresectable or metastatic NETs for dose-finding part of the study (b) Locally...
- For meningioma: histologically confirmed diagnosis of meningioma, i.e., all grades (1 to 3) per World Health Organization Classification of Tumors of...
- Radiological evidence of measurable disease by: (a) For NETs: RECIST v1.1 criteria on CT with contrast or MRI of the areas of tumor involvement...
- Lesions must have shown radiological evidence of disease progression in the 12 months prior to enrollment. (b) For meningioma: RANO meningioma...
You likely can't join if
- Known hypersensitivity to SSA, SSTR imaging agents or any of the excipients of [212Pb]VMT-α-NET.
- Known additional malignancy that is progressing or requires active treatment.
- Pregnancy or breastfeeding a child.
- Febrile illness within 48 hours of any scheduled [212Pb]VMT-α-NET administration should be rescheduled \> 48 hours after resolution of fever].
- Treatment with another investigational medicinal product within 30 days of anticipated treatment.
- Prior treatment with systemic PRRT based therapies (i.e., [90Y] DOTATATE/DOTATOC or [177Lu] DOTATATE)
See the full eligibility criteria
Who can join
- Adult (ages ≥18) PRRT-naïve people with NETs or meningioma by local pathology.
- Disease described clinically as: (a) Locally advanced/unresectable or metastatic NETs for dose-finding part of the study (b) Locally advanced/unresectable or metastatic GEP-NETs, bronchial NETs, pheochromocytoma, or...
- For meningioma: histologically confirmed diagnosis of meningioma, i.e., all grades (1 to 3) per World Health Organization Classification of Tumors of the Central Nervous System (5th edition; WHO-CNS5)
- Radiological evidence of measurable disease by: (a) For NETs: RECIST v1.1 criteria on CT with contrast or MRI of the areas of tumor involvement within 60 days of enrollment.
- Lesions must have shown radiological evidence of disease progression in the 12 months prior to enrollment. (b) For meningioma: RANO meningioma criteria on contrast-enhanced skull MRI for meningioma within 3 weeks prior...
- Demonstration of lesional SSTR expression: (a) For NETs: using an FDA-approved somatostatin receptor PET imaging agent, e.g. [68Ga]DOTATATE, [64Cu]DOTATATE, or [68Ga]DOTATOC (b) For meningioma: using a standard-of-care...
- ECOG Performance Status ≤ 1.
- people with HIV positivity are allowed if CD4 Count \> 350 cells/μL.
- Concurrent Somatostatin Analog (SSA) Therapy use while on protocol therapy is allowed provided that the subject must be able to tolerate withholding long-acting SSA therapy for a minimum of 28 days and short-acting SSA...
- For NETs: Progressive Disease on approved therapies other than radionuclide therapy.
- For people with meningioma who are receiving corticosteroid treatment, the dose must be ≤ 4 mg/day dexamethasone (or other corticosteroid equivalent dose) for a minimum of 7 days before the initiation of study treatment.
- Must have clinically demonstrated adequate catecholamine blockade if catecholamine-secreting pheochromocytoma/paraganglioma tumors are present.
- Able to understand and sign informed consent and comply with all study requirements.
- Life expectancy \> 3 months.
- Satisfactory organ function as determined by laboratory testing.
- For females of reproductive potential: agree to use of highly effective contraception and refrain from donating eggs (ova, oocytes) for the purpose of reproduction starting from screening, during treatment, and for at...
- For males of reproductive potential: agree to use of condoms or other methods to ensure effective contraception with partner and refrain from donating sperm starting from screening, during treatment, and for at least 6...
What rules you out
- Known hypersensitivity to SSA, SSTR imaging agents or any of the excipients of [212Pb]VMT-α-NET.
- Known additional malignancy that is progressing or requires active treatment.
- Pregnancy or breastfeeding a child.
- Febrile illness within 48 hours of any scheduled [212Pb]VMT-α-NET administration should be rescheduled \> 48 hours after resolution of fever].
- Treatment with another investigational medicinal product within 30 days of anticipated treatment.
- Prior treatment with systemic PRRT based therapies (i.e., [90Y] DOTATATE/DOTATOC or [177Lu] DOTATATE)
- Prior treatment with 90-Yttrium radioembolization must be completed at least 6 months prior to enrollment.
- External beam radiation therapy (EBRT) must be completed at least 30 days prior to enrollment.
- people who have received prior treatment with 90Y radioembolization or EBRT should have radiation absorbed dose to critical organs documented.
- Prior treatment with systemic anticancer therapy must be completed at least 30 days prior to enrollment (except for SSAs in people with functional tumors).
- Major surgery must be completed at least 30 days prior to enrollment.
- For people with NETs: Known brain metastases; unless these metastases have been treated and stabilized 6 months prior to enrollment and the subject has been off steroid support for at least 14 days prior to enrollment.
- Recently diagnosed and active infections requiring a time-limited course of antifungals or antibiotics in the 3 days prior to enrollment.
- Receipt of live attenuated vaccines in the 7 days prior to enrollment.
- Grade 3 nausea/vomiting or diarrhea within 72 hours before the of first scheduled dose of [212Pb]VMT-α-NET despite adequate antiemetic and other supportive care
- Known medical condition which would make this protocol unreasonably hazardous for the subject.
- Medical history of a condition resulting in a severe allergic reaction such as anaphylaxis or angioedema to known components of the Investigational Medicinal Product or excipients.
- Current abuse of alcohol or illicit drugs (exclusive of use of medically prescribed cannabinoids).
- Existence of any medical or social issues likely to interfere with study conduct or that may cause increased risk to the subject or to others, e.g., lack of ability to follow radiation safety precautions.
- QTc \> 450 milliseconds for males and females.
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- Troy, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States; Miami, Florida, United States; Chicago, Illinois, United States; Iowa City, Iowa, United States; Lexington, Kentucky, United States; Baltimore, Maryland, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.