Delving into the Latest Updates on [68Ga]-FF58 with Synapse

Overview

Basic Info

Drug Type

Chemical drugs, Diagnostic radiopharmaceuticals

Synonyms-

Target

αvβ3

Action

antagonists

Mechanism

αvβ3 antagonists(Integrin alpha-V/beta-3 antagonists)

Therapeutic Areas

NeoplasmsNervous System DiseasesDigestive System Disorders+ [2]

Active Indication-

Inactive Indication

Adenocarcinoma of EsophagusGlioblastomaGlioblastoma Multiforme+ [1]

Originator Organization-

Active Organization-

Inactive Organization

Novartis Pharmaceuticals Corp.Novartis Pharma AG

License Organization-

Drug Highest PhaseDiscontinuedPhase 1

First Approval Date-

Regulation-

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The purpose of the study is to test the safety and dosing of [177Lu]Lu-FF58, a radioligand therapy for patients with advanced or metastatic tumors that express proteins known as integrins: alpha-v beta-3 integrin (αvβ3) and alpha-v beta-5 integrin (αvβ5). The study will also further characterize the radioligand imaging agent [68Ga]Ga-FF58 including its ability to identify tumor lesions and its safety profile.

Start Date06 Oct 2023

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

NCT04712721

/ TerminatedEarly Phase 1

Phase I, Open-label, Multicenter Study to Evaluate the Imaging Performance, Safety, Biodistribution and Dosimetry of [68Ga]-FF58 in Adult Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins.

This is a First-In-Human (FIH) study of [68Ga]-FF58 to characterize the imaging properties, safety, biodistribution and dosimetry properties of [68Ga]-FF58 in adults with relapsed or refractory (r/r) glioblastoma multiforme (GBM), breast cancer (BC) that has metastasized to the brain, gastroesophageal adenocarcinoma (GEA) or pancreatic ductal adenocarcinoma (PDAC) expected to overexpress alpha-v beta 3 (αvβ3) and alpha-v beta 5 (αvβ5) integrins.

Start Date14 Oct 2021

Sponsor / Collaborator

Novartis Pharmaceuticals Corp.

100 Clinical Results associated with [68Ga]-FF58

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100 Translational Medicine associated with [68Ga]-FF58

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100 Patents (Medical) associated with [68Ga]-FF58

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100 Deals associated with [68Ga]-FF58

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of Esophagus	Phase 1	France	Novartis Pharmaceuticals Corp.	14 Oct 2021
Adenocarcinoma of Esophagus	Phase 1	Germany	Novartis Pharmaceuticals Corp.	14 Oct 2021
Glioblastoma Multiforme	Phase 1	France	Novartis Pharmaceuticals Corp.	14 Oct 2021
Glioblastoma Multiforme	Phase 1	Germany	Novartis Pharmaceuticals Corp.	14 Oct 2021
Pancreatic Ductal Adenocarcinoma	Phase 1	France	Novartis Pharmaceuticals Corp.	14 Oct 2021
Pancreatic Ductal Adenocarcinoma	Phase 1	Germany	Novartis Pharmaceuticals Corp.	14 Oct 2021
Glioblastoma	Phase 1	-	Novartis Pharma AG	11 Dec 2020