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All Drugs and Chemicals

Radiopharmaceuticals

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.

Patients with positive uptake on FDA approved SSTR2 PET/CT will receive a fixed dose of \[212Pb\]VMT-α-NET IV administered every 8 weeks for a maximum of four doses

[212Pb]VMT-α-NET

Patients with positive uptake on FDA approved SSTR2 PET/CT will receive a fixed dose of \[212Pb\]VMT-α-NET IV administered at the RPh2D and schedule determined in Phase I dose escalation

Markus Puhlmann, MD, MBA

Jason Starr, MD

Chih-Yi Liao, MD

Yusuf Menda, MD

Yvonne Taul

Lowell Anthony, MD, FACP

Lilja Solnes, MD

Neda Tehrani

Thorvardur R Halfdanarson, MD

John Crandall

Richard Wahl, MD

Samuel Mehr, MD

This study is Phase I/IIa First-in-Human Study of \[212Pb\]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors

This is a prospective, multi-center open-label dose escalation, dose expansion study of \[212Pb\]VMT01 in up to 52 adult subjects with unresectable or metastatic SSTR2-expressing neuroendocrine tumors (NETs) who have not received prior peptide receptor radionuclide therapy (PRRT).

The radioactivity dose escalation period (phase I) tests up to 4 escalating radioactivity dose cohorts of up to 8 subjects (administered at approximately 8-week intervals) at the assigned cohort radioactivity dose.

Pre-specified dose adjustments and individual stopping rules for repeat treatment cycles are based on observed dose-limiting toxicities (DLTs) and adverse events (AEs).

The Maximum Tolerated Dose (MTD) will be determined based on observed DLTs within 42 days of the first treatment cycle.

The recommended expansion dose(s) will be determined following a holistic analysis of observed DLTs, AEs, estimated cumulative organ radiation exposure, and efficacy signals over the course of all treatment cycles for all dose cohorts.

If MTD can not be identified within the 4 radioactivity dose cohorts, a Maximum Feasible Dose (MFD), incorporating manufacturing and logistical considerations for \[212Pb\]VMT-α-NET production, may be determined.

Reno-protective amino acids will be co-administered in a separate IV line prior to each \[212Pb\]VMT-α-NET dose in all subjects. Escalation will be based on a modified toxicity probability interval design \[mTPI-2\] until MTD is identified or the pre-specified rules are met.

A lead-in dosimetry sub-study will be conducted during the dose escalation period in which all subjects in the first two dose cohorts will undergo dosimetric evaluation prior to receiving the therapeutic agent.

A Phase I/IIa First-in-Human Study of \[212Pb\]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors

Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors

A Phase I/IIa First-in-Human Study of [212Pb]VMT-α-NET Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors

Any untoward medical occurrence in a clinical investigational participant administered \[212Pb\]VMT-α-NET and which does not necessarily have a causal relationship with this treatment

Determination of the overall response rate (ORR) by RECIST v1.1 in subjects with neuroendocrine tumors

Biodistribution will be calculated by utilizing SPECT/CT scans.

Perspective Therapeutics

Pharmaceutical Solutions

MK-0646 (20 mg/mL) in sterilized solution for IV infusion (12.7 mL to deliver 12.0 mL) will be used for a dose of 10 mg/kg IV weekly administered over 60 minutes.

MK-0646

Leonard Saltz, MD

The purpose of this study is to test a new drug for neuroendocrine tumors. We think that this new drug may help control your tumor.

MK-0646 is a monoclonal antibody. An antibody is a protein that is able to attach to specific target on cancer cells. This target helps the cancer cells grow and divide. By attaching to the target, it may stop the cancer cells from further growth and dividing. This study will help find out if MK-0646 is a helpful drug when taken in patients with neuroendocrine tumor.

This study is a phase 2 study. The purpose of a phase 2 study is to find out what effects, good and/or bad, MK-0646 has on metastatic neuroendocrine tumors.

Clinical and Translational Study of MK-0646 in Patients With Metastatic Neuroendocrine Tumors (NET)

A Phase II Clinical and Translational Study of MK-0646 in Patients With Metastatic Neuroendocrine Tumors (NET)

in patients with metastatic carcinoid tumors and in metastatic islet cell tumors (parallel cohorts) when treated with MK-0646 alone.

Merck Sharp & Dohme LLC

Memorial Sloan Kettering Cancer Center

Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)

Patients With Metastatic Neuroendocrine Tumors

Age, Categorical

Sex: Female, Male

Dr. Diane Reidy

Progression of Disease (POD)

Stable Disease (SD)

Objective Response Rate (ORR)

Overall Study

Symptoms and General Pathology

Neoplasm Metastasis

Neoplastic Processes

Antineoplastic Agents

3-Iodobenzylguanidine

Enzyme Inhibitors

I-131 Metaiodobenzylguanidine

Donald Podoloff, MD

The goal of this clinical research study is to learn if I-131 Metaiodobenzylguanidine (MIBG) can shrink or slow the growth of the tumor(s) in patients with metastatic neuroendocrine tumors. The safety of this treatment will also be studied.

MIBG is used to visualize a group of specific cells in the body. It has been known to deliver the radioactive iodine to the tumor (cancer) cells selectively and result in their destruction.

Before treatment starts, patients will be evaluated with a tracer scan, using either I-131 MIBG or I-123 MIBG to locate the tumor site(s). If no MIBG accumulation can be found within tumor sites, the patient will not be able to continue on this study. Patients will also have CT scans and urine and blood tests. Women able to have children will have a pregnancy test.

If tumor sites are found and patients are fully eligible, they will receive a therapeutic (treatment) dose of I-131 MIBG by vein over 120 minutes. Some patients may have to receive a lower dose of MIBG. Patients will require hospitalization for treatment and will remain hospitalized for about 3-6 days.

High Dose I-131 Metaiodobenzylguanidine(MIBG) for Metastatic Neuroendocrine Tumors

High Dose I-131 Metaiodobenzylguanidine (MIBG) Therapy for Metastatic Neuroendocrine Tumors

M.D. Anderson Cancer Center

Syndrome

Disease Progression

Gastrointestinal Agents

Octreotide

Vatalanib

Protein Kinase Inhibitors

Intervention=Patients will receive treatment with PTK787/ZK222584 daily. A treatment cycle will be defined as a 28-day period. Subjects will continue on their present treatment regimen of receiving Sandostatin LAR 30mg IM every 4 weeks.

Subjects who meet all inclusion and exclusion criteria will receive an initial dose of PTK787/ZK222584 1,250mg once daily, and subjects will remain on the scheduled doses of Sandostatin LAR 30mg every 4 weeks.

vatalanib

Lowell B Anthony, MD

The purpose of this study is to examine if PTK787/ZK222584 (vatalanib) will stabilize or decrease rising biochemical markers along with progressive disease or syndrome symptoms in patients with metastatic neuroendocrine tumors.

This is an open-label, phase II study evaluating the safety and efficacy of PTK787/ZK222584 administered daily in subjects with neuroendocrine tumors that are experiencing progressive disease and/or whose tumor-related syndrome symptoms (flushing and diarrhea) are considered inadequately controlled despite optimal doses of octreotide therapy. Inadequate control is defined as a minimum of 2 flushing episodes or 6 bowel movements per day for 7 consecutive days. Subjects who meet all inclusion and exclusion criteria and have completed all baseline and screening testing will receive an initial dose of PTK787/ZK222584 1,250 mg once daily and subjects will also remain on the scheduled doses of Sandostatin LAR 30 mg every 4 weeks. Both drugs will be dosed on a flat schedule of mg, not by weight or body surface area. The PTK787/ZK222584 medication will be taken orally with daily dosing. Each tablet of PTK787/ZK 222584 is 250 mg. The subject will take five tablets of study medication per day 2 tabs am and 3 tabs pm. Subjects may continue to receive therapy as long as they do not experience unacceptable toxicities or evidence of disease progression as defined by RECIST criteria. Subjects will be evaluated with a daily log to assess the degree of symptom control (flushing and diarrhea) and subjects will be monitored every 2 weeks for 3 months then monthly for biochemical control and every three months for tumor response. Subjects will be monitored by the Investigator every two weeks for 3 months then monthly for safety and efficacy.

Safety and Efficacy Study of PTK787/ZK222584 to Treat Metastatic Neuroendocrine Tumors

An Open-label Phase II Study Evaluating the Safety and Efficacy of PTK787/ZK222584 in Patients With Metastatic Neuroendocrine Tumors That Have Evidence of Progressive Disease or an Increase in Disease Related Syndrome Symptoms.

Novartis

Louisiana State University Health Sciences Center in New Orleans

Lowell Anthony, MD

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors	NCT05636618	Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Neuroendocrine ... Carcinoid Tumor... Carcinoid Tumor Paraganglioma Pheochromocytom...	[212Pb]VMT-α-NE... [212Pb]VMT-α-NE...	18 Years - 90 Years	Perspective Therapeutics
Clinical and Translational Study of MK-0646 in Patients With Metastatic Neuroendocrine Tumors (NET)	NCT00610129	Neuroendocrine ... Metastatic Neur...	MK-0646	18 Years -	Memorial Sloan Kettering Cancer Center
High Dose I-131 Metaiodobenzylguanidine(MIBG) for Metastatic Neuroendocrine Tumors	NCT00037869	Neuroendocrine ... Metastases, Neo...	I-131 Metaiodob...	2 Years -	M.D. Anderson Cancer Center
Clinical and Translational Study of MK-0646 in Patients With Metastatic Neuroendocrine Tumors (NET)	NCT00610129	Neuroendocrine ... Metastatic Neur...	MK-0646	18 Years -	Memorial Sloan Kettering Cancer Center
Clinical and Translational Study of MK-0646 in Patients With Metastatic Neuroendocrine Tumors (NET)	NCT00610129	Neuroendocrine ... Metastatic Neur...	MK-0646	18 Years -	Memorial Sloan Kettering Cancer Center
Safety and Efficacy Study of PTK787/ZK222584 to Treat Metastatic Neuroendocrine Tumors	NCT00590343	Metastatic Neur...	vatalanib	18 Years -	Louisiana State University Health Sciences Center in New Orleans
Safety and Efficacy Study of PTK787/ZK222584 to Treat Metastatic Neuroendocrine Tumors	NCT00590343	Metastatic Neur...	vatalanib	18 Years -	Louisiana State University Health Sciences Center in New Orleans

Spots Global Cancer Trial Database for metastatic neuroendocrine tumors