Phase I/II Trial of Systemic Targeted Radioligand Therapy (TRT) With Somatostatin-Receptors (SSTR)-Agonist [212Pb]VMT-alpha-NET in Metastatic or Inoperable SSTR Positive (SSTR+) Gastrointestinal (GI) Neuroendocrine Tumors (NET) and Pheochromocytoma/Paragangliomas Previously Treated With Systemic Radioligand Therapy

Background:
Gastrointestinal neuroendocrine tumors (GI NET) are a type of cancer that affects the stomach and intestines; pheochromocytoma/paragangliomas (PPGL) are tumors that grow in or near the adrenal glands. Both of these types of tumor have high levels of a protein called somatostatin receptors (SSTR) on their surfaces. Researchers want to test a treatment that targets SSTR.
Objective:
To test a drug ([212Pb]VMT-alpha-NET) in people with GI NET or PPGL. The drug has 2 components: a protein to bind to SSTR and a radioactive agent to kill the cancer cells.
Eligibility:
Adults aged 18 years or older with GI NET or PPGL tumors that have spread and cannot be removed with surgery.
Design:
Participants will be screened. They will have a physical exam, with imaging scans, blood tests, and tests of their heart function.
[212Pb]VMT-alpha-NET is given through a tube attached to a needle inserted into a vein (infusion). Treatment will be given in four 8 week cycles. Participants will receive the drug on the first day of each cycle. They will remain in the clinic at least 4 hours after each infusion and may nee to stay in th hospital for up to 48 hour for monitoring and testing. They will have blood tests every week of each cycle.
Some participants will also get a related study drug ([203Pb]VMT-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 for 10 years....

开始日期2024-11-07

申办/合作机构

National Cancer Institute

NCT06479811 / Not yet recruiting临床1期IIT

Phase I Trial of [212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive Gastrointestinal Neuroendocrine Tumors, Pheochromocytoma/Paragangliomas, Small Cell Lung, Renal Cell, and Head and Neck Cancers

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 ([212Pb]VMT-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.
[212Pb]VMT-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 ([203Pb]VMT-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.

开始日期2024-11-07

申办/合作机构

National Cancer Institute

NCT06148636 / Active, not recruiting早期临床1期IIT

A Phase 1, First-in-human Clinical Trial of [212Pb] VMT-alpha-NET Using a Forward Dosimetric Planning Technique to Treat Refractory or Relapsed Neuroendocrine Tumors

This is a safety study to determine the recommended dose to test in clinical trials. The study involves two treatments with 212Pb (212-lead) VMT-α-NET. This is a safety study only; it will most likely not provide therapeutic benefit.

开始日期2023-11-10

申办/合作机构

University of Iowa

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100 项与 [212Pb]VMT-α-NET 相关的临床结果

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100 项与 [212Pb]VMT-α-NET 相关的转化医学

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项与 [212Pb]VMT-α-NET 相关的文献（医药）

2024-06-01·Clinical nuclear medicine

Charting the Course of Targeted α Therapy With First-in-Human, Postadministration Image-Guided Dosimetry and Response Assessment of 212Pb-VMT-α-NET in Metastatic Neuroendocrine Tumors

Article

作者: Sen, Ishita B ; Rana, Nishant ; Malik, Dharmender ; Schultz, Michael K ; Thakral, Parul ; Singh, Navneet

Abstract:

212Pb emerges as a compelling in vivo α-particle generator for targeted α therapy due to its favorable half-life (t1/2 = 10.6 hours) aligning with the biological half-lives of small peptides and its potent α-particle emissions within the decay series. However, one of the challenges with 212Pb is to perform appropriate image-guided dosimetry. To date, all the data have been extrapolated from its imaging analog, 203Pb. We present the first-in-human posttherapy image-guided dosimetric estimates of a single cycle of 212Pb VMT-α-peptide, administered in a 41-year-old woman with an advanced grade 2 NET. The patient also demonstrated partial response on treatment.

2021-12-07·British journal of cancer1区 · 医学

Preclinical study of 212Pb alpha-radioimmunotherapy targeting CD20 in non-Hodgkin lymphoma

1区 · 医学

Article

作者: Garot, Armand ; Saidi, Amal ; Durand-Panteix, Stéphanie ; Clavel, Marie ; Cogne, Michel ; Sage, Magali ; Torgue, Julien ; Quelven, Isabelle ; Monteil, Jacques

BACKGROUND:

Despite therapeutic advances, Non-Hodgkin lymphoma (NHL) relapses can occur. The development of radioimmunotherapy (RIT) with α-emitters is an attractive alternative. In this study, we investigated the potential of α-RIT in conjunction with ²¹²Pb-rituximab for the treatment of NHL.

METHODS:

EL4-hCD20-Luc cells (mouse lymphoma cell line) were used for in vitro and in vivo studies. Biodistribution and efficacy studies were performed on C57BL/6 mice injected intravenously with 25 × 10³ cells.

RESULTS:

²¹²Pb-rituximab (0.925-7.4 kBq/mL) inhibit proliferation of EL4-hCD20-Luc cells in vitro. Biodistribution of ^203/212Pb-rituximab in mice showed a significant tumour uptake and suggested that the liver, spleen, and kidneys were the organs at risk. For efficacy studies, mice were treated at either 11 days (early stage) or 20-30 days after injection of tumour cells (late stage). Treatment with 277.5 kBq ²¹²Pb-rituximab significantly prolonged survival. Even at an advanced tumour stage, significant tumour regression occurred, with an increase in the median survival time to 28 days, compared with 9 days in the controls.

CONCLUSIONS:

These results show the efficacy of ²¹²Pb-rituximab in a murine syngeneic lymphoma model, in terms of significant tumour regression and increased survival, thereby highlighting the potency of α-RIT for the treatment of NHL.

项与 [212Pb]VMT-α-NET 相关的新闻（医药）

2023-03-14

·BioSpace

Perspective Therapeutics and PharmaLogic announce collaboration for the development and production of theranostics for cancer care

BOCA RATON, Fla. and RICHLAND, Wash., March 14, 2023 /PRNewswire/ -- PharmaLogic Holdings Corp. ("PharmaLogic" or "the Company"), a contract development and manufacturing organization and radiopharmaceutical manufacturer, today announces the signature of a Master Services Agreement with Viewpoint Molecular Targeting, Inc., a wholly-owned subsidiary of Perspective Therapeutics, Inc. ("Perspective") (NYSE AMERICAN: CATX), for the development and production of theranostic candidates VMT-01 and VMT-α-NET. The radiopharmaceuticals are currently in development for the diagnosis and treatment of metastatic melanoma and neuroendocrine tumors (NETs), respectively. Under the terms of the agreement, PharmaLogic will produce and supply doses of VMT-01 and VMT-α-NET for use in Perspective's early-stage clinical trials. This will complement the existing radiopharmaceutical GMP capability that Perspective already has at its mid-west site. Scott Holbrook, PharmaLogic's Chief Strategy Officer and General Manager, stated, "Targeted alpha therapy (TAT) with Pb-212 labeled radioligands offers one of the most exciting platforms for novel cancer therapy within the rapidly expanding precision radiotherapy ecosystem. The expertise of Perspective Therapeutics and PharmaLogic are well aligned to yield a successful collaboration around VMT-01 and VMT-α-NET." "We are delighted to select PharmaLogic as a trusted CDMO partner at this important juncture of the Viewpoint's clinical development journey," said Thijs Spoor, Perspective Therapeutics' CEO. "Radiopharmaceutical diagnostic imaging and therapeutic agents have a limited shelf life from time of manufacture to patient administration in the clinical setting. PharmaLogic's domain expertise in radiopharmaceuticals and broad national distribution footprint helps address our need for specialty radiopharmaceutical manufacturing at the highest level. As we have been given the safe to proceed authorizations from the U.S. Food and Drug Administration, we look forward to commencing enrollment of the Company's two image guided alpha-particle therapy studies at multiple clinical trial centers around the country. Furthermore, we look forward to reporting preliminary results from the clinical trials later in the year." "PharmaLogic is excited to partner with Perspective Therapeutics on the production and distribution of these personalized alpha-particle theranostics," said Chris Parr, PharmaLogic's Vice President of Radiochemistry and Technical Operations. "We value Perspective's scientific leadership in this area and believe it aligns perfectly with our mission of delivering clinically relevant precision medicine products to patients in the communities we serve." About PharmaLogic Holdings Corp. PharmaLogic is a world-class contract development and manufacturing organization specializing in novel diagnostic imaging and therapeutic radiopharmaceuticals for the treatment of cancers and other malignancies. In addition to an established and reliable network of radiopharmacies, PharmaLogic has decades of expertise in drug development from discovery, through manufacturing and commercialization. The Company seeks to take the lead in the advancement of radiopharmaceutical technology for the benefit of patients worldwide. For more information, visit: About Perspective Therapeutics Perspective Therapeutics, Inc., formerly known as Isoray, Inc., is a medical technology and radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body. Perspective Therapeutics is the sole producer of Cesium-131 brachytherapy seeds and has a proprietary technology that utilizes the isotope lead-212 to deliver powerful alpha radiation specifically to cancer cells via specialized targeting peptides. Perspective Therapeutics is also developing complementary imaging diagnostics that incorporate the same targeting peptides which provide the opportunity to personalize treatment and optimize patient outcomes. This "theranostic" approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity associated with many other types of cancer treatments. Perspective Therapeutics' melanoma (VMT01) and neuroendocrine tumor (VMT-α-NET) programs are entering Phase 1/2a imaging and therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors at several leading academic institutions. The Company has also developed a proprietary lead-212 generator to secure isotope supply for clinical trial and commercial operations. For more information, please visit their website at . Safe Harbor Statement Statements in this news release about Perspective Therapeutics, Inc.'s ("Perspective") and its wholly-owned subsidiary Viewpoint Molecular Targeting, Inc.'s ("Viewpoint," and together with Perspective, the "Company") future expectations, including: the functionality and capabilities of the Company's therapies including its targeted alpha-particle radiotherapy and its theranostic candidates VMT-01 and VMT- α-NET; the potential size of the commercial market for the Company's treatment programs; the Company's expectations, beliefs, intentions, and strategies regarding the future; and all other statements in this news release, other than historical facts, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 ("PSLRA"). This statement is included for the express purpose of availing the Company of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as whether the alpha-particle therapy studies referred to in this news release are conducted on the anticipated timelines or are successful; the ability to raise ongoing capital to fund added costs of research and development related to the Company's business; the ability of the Company to manage growth and successfully integrate its businesses; whether the Company can maintain its key employees; the risk that the recent merger disrupts current plans and operations; the outcome of any legal proceedings that may be instituted against the Company following consummation of the merger; whether the Company's anticipated product pipeline is achieved; whether additional studies are released that reinforce the results of the studies discussed in this presentation; whether the anticipated benefits of the Company's therapies are realized; training and use of the Company's products; market acceptance and recognition of the Company's products; the Company's ability to enforce its intellectual property rights; whether ongoing patient results are favorable and in line with the conclusions of clinical studies and initial patient results; successful completion of future research and development activities; whether we, our distributors, and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell, and use our products in their various forms; the procedures and regulatory requirements mandated by the FDA for animal trials, human trials, clinical studies, Phase I and II approvals, fast track approvals, and 510(k) approval and reimbursement codes; changes in applicable laws and regulations; and other risks detailed from time to time in the Company's reports filed with the SEC. Unless required to do so by law, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. For more information regarding risks and uncertainties that could affect the Company's results of operations or financial condition, please review the definitive Proxy Statement filed on November 7, 2022, and our Form 10-K filed on September 28, 2022, with the SEC. Company Codes: AMEX:CATX

引进/卖出放射疗法

2022-10-03

·BioSpace

Viewpoint Molecular Targeting Announces VMT-𝛼-NET Granted U.S. FDA Fast Track Destination for the Treatment of Neuroendocrine Tumors

CORALVILLE, IA / ACCESSWIRE / October 3, 2022 / Viewpoint Molecular Targeting, Inc. ("Viewpoint" or the "Company"), a radiopharmaceutical company developing precision lead-212-based α-particle oncology therapeutics and complementary diagnostic imaging agents, today announced that the U.S. Food and Drug Administration (FDA) has granted fast track designation for the development of [212Pb]VMT-α-NET for treatment of patients with SSTR2-positive unresectable or metastatic neuroendocrine tumors (NETs) (including GEP-NETs or bronchial NETs and pheochromocytomas and paragangliomas). "Although several exciting new medicines have emerged in the past decade for patients with neuroendocrine tumors, there remains an unmet need for certain patient segments, where survival rates remain low" said Dr Frances Johnson, M.D., COO and co-founder of Viewpoint. Added Michael Schultz, Ph.D., CSO and co-founder of Viewpoint, "we applied for fast track designation based on the compelling results seen in head-to-head animal studies and are appreciative of the FDA being able to review the data expeditiously." The Company expects the results of those studies to be presented publicly at the upcoming European Association of Nuclear Medicine (EANM) conference to be held October 15-19, 2022 in Barcelona, Spain. "We are thrilled to receive FDA Fast Track Designation for our leading program," said Thijs Spoor, CEO of Viewpoint. "This designation will allow us to actively explore the fastest ways to bring our personalized alpha-particle theranostics to patients." The FDA Fast Track Designation is one of several approaches utilized by the FDA to expedite development and review of potential medicines for serious conditions and that fulfill unmet medical needs. A potential new medicine may fill an unmet medical need by being the first therapy to address a specific serious condition, offer clinically significant advantages over available therapies, act via a different mechanism of action than available therapies, or have a benefit in patients who are unresponsive to or intolerant of available therapies. Programs that receive Fast Track Designation are entitled to more frequent interactions with the FDA on drug development plan, as well as eligibility for accelerated approval, priority review, and rolling review. About Neuroendocrine Tumors (NET) Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. Neuroendocrine tumors are typically classified as pancreatic neuroendocrine tumors or non-pancreatic neuroendocrine tumors. According to cancer.net, it is estimated that more than 12,000 people in the United States are diagnosed with a NET each year. Importantly, neuroendocrine tumors are associated with a relatively long duration of survival compared to other tumors and as a result, there are approximately 175,000 people living with this diagnosis. About Viewpoint Molecular Targeting Viewpoint Molecular Targeting is a radiopharmaceutical company developing precision oncology therapeutics and complementary diagnostic imaging agents. The Company's proprietary technology utilizes the isotope lead-212 to deliver powerful alpha radiation specifically to cancer cells via specialized targeting peptides. Viewpoint is also developing complementary imaging diagnostics that incorporate the same targeting peptides which provide the opportunity to personalize treatment and optimize patient outcomes. This "theranostic" approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity associated with many other types of cancer treatments. The Company's melanoma (VMT01) and neuroendocrine tumor (VMT-𝛼-NET) programs are entering Phase 1/2a imaging and therapy trials for the treatment of metastatic melanoma and neuroendocrine tumors at several leading academic institutions. The Company has also developed a proprietary lead-212 generator to secure isotope supply for clinical trial and commercial operations. For more information, please visit the Company's website . Viewpoint previously announced on September 29, 2022 that it has entered into a definitive agreement to merge with Isoray, Inc (NYSE AMERICAN:ISR), a medical technology company and innovator in seed brachytherapy. Additional details regarding the contemplated merger along with the merger agreement can be found in Isoray Inc.'s current report on Form 8-K which was filed with the Securities and Exchange Commission on September 28, 2022. The consummation of the merger is subject to approval by the shareholders of both Isoray and Viewpoint along with other customary closing conditions. Forward-Looking Statements This press release contains information that includes or is based upon "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company's expectations or forecasts regarding future events. These statements can be identified by the fact they do not relate strictly to historical or current facts. They may use words such as "believe," "potential," "estimate," "expect," "will," and other terms of similar meaning in connection with a discussion of future operating or financial performance. In particular, forward-looking statements include statements relating to intended future actions; the Company's expectations about its addressable markets and market share; the consummation of the merger with Isoray and the realization of the anticipated benefits of the combination; the functionality and capabilities of the Company's therapies; the potential size of the commercial market for the Company's treatment programs; and the Company's expectations beliefs, intentions or strategies regarding the future. Any or all of the Company's forward-looking statements here and elsewhere may turn out to be wrong. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements and from expected or historical results. Many such factors will be important in determining the Company's actual future results. Consequently, no forward-looking statement can be guaranteed. The Company undertakes no obligation to correct or update any forward-looking statements, whether as a result of new information, future developments, or otherwise, except to the extent required by applicable law. These forward-looking statements (except as may be otherwise noted) speak only as of the date of this press release. Factors or events that could cause the Company's actual results to differ may emerge from time to time, and it is not possible for the Company to predict all of them. Contacts Investor / Media / Public Relations: Thijs Spoor (319) 665-2150 SOURCE: Viewpoint Molecular Targeting, Inc. View source version on accesswire.com:

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
胃肠道神经内分泌肿瘤	临床2期	美国	National Cancer Institute	2024-11-07
SSTR阳性胃肠胰神经内分泌肿瘤	临床2期	美国	National Cancer Institute	2024-11-07
黑色素瘤	临床2期	美国	University of Wisconsin Madison	2024-05-24
类癌	临床2期	美国	Perspective Therapeutics, Inc.	2023-09-27
胃肠道肿瘤	临床2期	美国	Perspective Therapeutics, Inc.	2023-09-27
神经内分泌癌	临床2期	美国	Perspective Therapeutics, Inc.	2023-09-27
肺神经内分泌肿瘤	临床2期	美国	Perspective Therapeutics, Inc.	2023-09-27
胰腺癌	临床2期	美国	Perspective Therapeutics, Inc.	2023-09-27
嗜铬细胞瘤	临床2期	美国	Perspective Therapeutics, Inc.	2023-09-27
小细胞肺癌	临床2期	美国	Perspective Therapeutics, Inc.	2023-09-27