Ignite Creation Date:
2024-07-17 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479811
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-27
Brief Title:
212PbVMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors PheochromocytomaParagangliomas Small Cell Lung Renal Cell and Head and Neck Cancers
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I Trial of 212PbVMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors PheochromocytomaParagangliomas Small Cell Lung Renal Cell and Head and Neck Cancers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09-26
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
Some cancers have high levels of proteins called somatostatin receptors SSTRs on the surface of the tumors These tumors can be in the lung head and neck digestive tract kidneys and in or near the adrenal glands Researchers want to know if drug treatments that target SSTRs can help shrink these types of tumors
Objective
To test a study drug 212PbVMT-Alpha-NET in people with tumors that have SSTRs
Eligibility
People aged 18 years and older with tumors of the lung kidneys head and neck digestive tract or adrenal glands that have SSTRs Their tumors must have spread to other organs and cannot be removed with surgery
Design
Participants will be screened They will have a physical exam with blood and urine tests They will have imaging scans and a test of their heart function A sample of tumor tissue may be collected if one is not already available
212PbVMT-Alpha-NET is given through a tube attached to a needle inserted into a vein The drug will be given on the first day of four 8-week cycles Participants will stay in the hospital for a few nights after each dose They will have blood tests once a week during each cycle
Some participants will also get a related study drug 203PbVMT-Alpha-NET They will receive this drug a few days before the first 2 cycles At 4 24 and 48 hours after each infusion they will have whole body scans These scans will show where the study drug went in their body
Follow-up visits will continue up to 6 years after the last treatment
Some cancers have high levels of proteins called somatostatin receptors SSTRs on the surface of the tumors These tumors can be in the lung head and neck digestive tract kidneys and in or near the adrenal glands Researchers want to know if drug treatments that target SSTRs can help shrink these types of tumors
Objective
To test a study drug 212PbVMT-Alpha-NET in people with tumors that have SSTRs
Eligibility
People aged 18 years and older with tumors of the lung kidneys head and neck digestive tract or adrenal glands that have SSTRs Their tumors must have spread to other organs and cannot be removed with surgery
Design
Participants will be screened They will have a physical exam with blood and urine tests They will have imaging scans and a test of their heart function A sample of tumor tissue may be collected if one is not already available
212PbVMT-Alpha-NET is given through a tube attached to a needle inserted into a vein The drug will be given on the first day of four 8-week cycles Participants will stay in the hospital for a few nights after each dose They will have blood tests once a week during each cycle
Some participants will also get a related study drug 203PbVMT-Alpha-NET They will receive this drug a few days before the first 2 cycles At 4 24 and 48 hours after each infusion they will have whole body scans These scans will show where the study drug went in their body
Follow-up visits will continue up to 6 years after the last treatment
Detailed Description:
Background
Somatostatin receptors SSTR have been shown to be over-expressed in a number of human tumors including gastrointestinal GI neuroendocrine tumors NET pheochromocytomaparagangliomas PPGL small cell lung cancers SCLC kidney cancers KC and some head and neck HN cancers
Targeted radioligand therapy TRT is a class of cancer therapeutic agents formed by attaching a radioactive isotope to a ligand that can target specific surface receptors such as SSTR on a tumor cell membrane Efficacy is typically determined by the radiation dose deposited onto a tumor which is determined by the radioactive isotope being used as well as the binding characteristics of the ligand-receptortransporter pair
Alpha emitters such as 212Pb emit alpha particles that are more damaging to tumor cells than beta emitters such as 177Lu Therefore TRT agents using alpha emitters are considered to be more potent than beta-emitting TRTs
VMT-Alpha-NET is a peptide that binds to SSTR which when attached to 212Pb becomes an alpha particle-emitting TRT that can be used to treat tumors that have SSTR surface expression
203PbVMT-Alpha-NET is the chemically identical imaging surrogate for 212PbVMT-Alpha-NET and has the same mechanism of action via binding to SSTR2 The nuclide 203Pb contained in 203PbVMT-Alpha-NET emits gamma radiation suitable for single-photon emission computerized tomography SPECT imaging These images can be used to assess drug product biodistribution throughout the body
Objective
-To determine the maximum tolerated dose MTD of 212PbVMT-Alpha-NET dose escalation cohort and assess the safety of 212PbVMT-Alpha-NET at the MTD dose expansions cohorts
Eligibility
Age 18 years
Histopathologically confirmed GI NET PPGL SCLC KC or HN nasopharyngeal carcinoma NPC olfactory neuroblastoma ONB sinonasal neuroendocrine carcinoma SNEC cancers that are metastatic or inoperable
No prior systemic radioligand therapy
Eastern Cooperative Oncology Group ECOG Performance Status 1
Design
This is an open-label single-arm single-center phase I study evaluating the safety preliminary efficacy and pharmacokinetic properties of 212PbVMT-Alpha-NET in GI NET PPGL SCLC KC or HN cancers
First participants will be accrued in Dose Escalation Part with 4 dose levels to estimate MTD of 212PbVMT-Alpha-NET Once MTD is estimated the following participants with GI NET PPGL SCLC KC or HN cancers will be accrued in separate cohorts and treated at MTD of 212PbVMT-Alpha-NET
212PbVMT-Alpha-NET will be given IV every 8 weeks for a total of 4 administrations
A subset of participants Dosimetry Arm 1 will have 203PbVMT-Alpha-NET administration followed by whole-body gamma scans combined with dosimetry SPECT Computed Tomography CT scans and collection of blood and urine samples prior to the first and the second doses of 212PbVMT-Alpha-NET Cycles 1-2
All participants will undergo serial whole-body dose rate measurements after 203PbVMT-Alpha-NET andor 212PbVMT-Alpha-NET administration
Participants will have timed clinical laboratory evaluations imaging studies and research blood and urine samples while on the study therapy for safety and efficacy evaluations
Following completion of treatment participants will be seen at the NIH Clinical Center approximately 30 days later every 12 weeks for 3 years after that for safety and efficacy assessments Beyond 3 years participants will be contacted annually through any NIH-approved platform to assess for overall survival and health status
Somatostatin receptors SSTR have been shown to be over-expressed in a number of human tumors including gastrointestinal GI neuroendocrine tumors NET pheochromocytomaparagangliomas PPGL small cell lung cancers SCLC kidney cancers KC and some head and neck HN cancers
Targeted radioligand therapy TRT is a class of cancer therapeutic agents formed by attaching a radioactive isotope to a ligand that can target specific surface receptors such as SSTR on a tumor cell membrane Efficacy is typically determined by the radiation dose deposited onto a tumor which is determined by the radioactive isotope being used as well as the binding characteristics of the ligand-receptortransporter pair
Alpha emitters such as 212Pb emit alpha particles that are more damaging to tumor cells than beta emitters such as 177Lu Therefore TRT agents using alpha emitters are considered to be more potent than beta-emitting TRTs
VMT-Alpha-NET is a peptide that binds to SSTR which when attached to 212Pb becomes an alpha particle-emitting TRT that can be used to treat tumors that have SSTR surface expression
203PbVMT-Alpha-NET is the chemically identical imaging surrogate for 212PbVMT-Alpha-NET and has the same mechanism of action via binding to SSTR2 The nuclide 203Pb contained in 203PbVMT-Alpha-NET emits gamma radiation suitable for single-photon emission computerized tomography SPECT imaging These images can be used to assess drug product biodistribution throughout the body
Objective
-To determine the maximum tolerated dose MTD of 212PbVMT-Alpha-NET dose escalation cohort and assess the safety of 212PbVMT-Alpha-NET at the MTD dose expansions cohorts
Eligibility
Age 18 years
Histopathologically confirmed GI NET PPGL SCLC KC or HN nasopharyngeal carcinoma NPC olfactory neuroblastoma ONB sinonasal neuroendocrine carcinoma SNEC cancers that are metastatic or inoperable
No prior systemic radioligand therapy
Eastern Cooperative Oncology Group ECOG Performance Status 1
Design
This is an open-label single-arm single-center phase I study evaluating the safety preliminary efficacy and pharmacokinetic properties of 212PbVMT-Alpha-NET in GI NET PPGL SCLC KC or HN cancers
First participants will be accrued in Dose Escalation Part with 4 dose levels to estimate MTD of 212PbVMT-Alpha-NET Once MTD is estimated the following participants with GI NET PPGL SCLC KC or HN cancers will be accrued in separate cohorts and treated at MTD of 212PbVMT-Alpha-NET
212PbVMT-Alpha-NET will be given IV every 8 weeks for a total of 4 administrations
A subset of participants Dosimetry Arm 1 will have 203PbVMT-Alpha-NET administration followed by whole-body gamma scans combined with dosimetry SPECT Computed Tomography CT scans and collection of blood and urine samples prior to the first and the second doses of 212PbVMT-Alpha-NET Cycles 1-2
All participants will undergo serial whole-body dose rate measurements after 203PbVMT-Alpha-NET andor 212PbVMT-Alpha-NET administration
Participants will have timed clinical laboratory evaluations imaging studies and research blood and urine samples while on the study therapy for safety and efficacy evaluations
Following completion of treatment participants will be seen at the NIH Clinical Center approximately 30 days later every 12 weeks for 3 years after that for safety and efficacy assessments Beyond 3 years participants will be contacted annually through any NIH-approved platform to assess for overall survival and health status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 001709-C | None | None | None |