Sartate (67Cu MeCOSar octreotate) / Clarity Pharma - LARVOL DELTA

67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk, Relapsed, Refractory Neuroblastoma (clinicaltrials.gov) - P1/2 | N=21 | Terminated | Sponsor: Clarity Pharmaceuticals Ltd | Trial primary completion date: Oct 2024 ➔ Jan 2025

Trial primary completion date • Neuroblastoma • Oncology • Pediatrics • Solid Tumor

67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk, Relapsed, Refractory Neuroblastoma (clinicaltrials.gov) - P1/2 | N=21 | Terminated | Sponsor: Clarity Pharmaceuticals Ltd | N=34 ➔ 21 | Trial completion date: Dec 2028 ➔ Mar 2025 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2028 ➔ Oct 2024; Sponsor decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Neuroblastoma • Oncology • Pediatrics • Solid Tumor

Copper-67 based targeted radioligand therapy to the somatostatin receptor 2 (SSTR2) provides added efficacy and may prime small cell lung cancer for immunotherapy (AACR 2025) - "Biodistribution studies demonstrated high tumor-specific uptake for [64Cu]- and [67Cu]-Cu-SARTATE in this mouse syngeneic SCLC model. A dose escalation study demonstrated copper-67-based TCT could be used to effectively inhibit tumor growth with minimal radiotoxicity. The combination of TCT with ICTs improved overall survival compared to single-treatment control groups."

Clinical • IO biomarker • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • SSTR • SSTR2

First Participant Treated Using NorthStar Medical Radioisotopes’ Electron Accelerator-produced Copper-67 (Cu-67) in Clarity Pharmaceuticals’ Phase I/IIa Theranostic Clinical Trial Investigating Cu-67 SARTATE for Treatment of Neuroblastoma (Businesswire) - "NorthStar Medical Radioisotopes, LLC...is pleased to announce that the first patient has been dosed in a clinical trial using NorthStar’s electron accelerator-produced Cu-67. Administration of the therapeutic dose took place as part of an ongoing Phase I/IIa theranostic clinical trial conducted by Clarity Pharmaceuticals to investigate the safety and efficacy of Cu-67 SARTATE in pediatric patients with high-risk neuroblastoma."

Trial status • Neuroblastoma • Oncology • Solid Tumor

Interaction of Radiopharmaceuticals with Somatostatin Receptor 2 Revealed by Molecular Dynamics Simulations. (PubMed, J Chem Inf Model) - "Therefore, in this work, we carefully analyzed the key dynamical features and detailed molecular interactions of SSTR2 in complex with six radiopharmaceutical compounds selected among the few already in use (Cu/Ga-DOTATATE, Ga-DOTATOC, Cu-SARTATE) and some in clinical development (Ga-DOTANOC, Cu-TETATATE)...We thus unveiled detailed molecular interactions crucial for the recognition of this class of radiopharmaceuticals. The microscopically well-founded analysis presented in this study provides guidelines for the design of new potent ligands targeting SSTR2."

Journal • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor • SSTR • SSTR2

Cu Treatment Planning and Cu Therapy with Radiolabelled SARTATE ([Cu/Cu]MeCOSAR-Octreotate) in Subjects with Unresectable Multifocal Meningioma - Initial Results for Human Imaging, Safety, Biodistribution and Radiation Dosimetry. (PubMed, J Nucl Med) - "Further clinical studies will be required to examine the therapeutic dose required for [Cu]Cu-SARTATE for various indications. In addition, the ability to use predictive copper-64 based dosimetry for treatment planning with copper-67 should be further explored."

Journal • Brain Cancer • CNS Tumor • Meningioma • Oncology • Solid Tumor • SSTR

"#Clarity advances to cohort 3 of the #CL04 trial of #SARTATE in #PaediatricNeuroblastoma $CU6 https://t.co/fp7FerL2XJ" (@1stOncology)

Oncology • Pediatrics • Solid Tumor

Clarity advances to cohort 3 of the CL04 trial of SARTATE in paediatric neuroblastoma (PRNewswire) - "Clarity Pharmaceuticals...is pleased to announce it has completed cohort 2 and advanced to cohort 3 in the theranostic 64Cu/67Cu SARTATE™ neuroblastoma trial (CL04 trial)....No Dose Limiting Toxicities (DLTs) have been reported in cohort 1 and cohort 2; Safety Review Committee (SRC) has recommended the trial continues with the dose escalation phase as planned; Recruitment of cohort 3 is open at all five clinical sites in the US at the increased dose level of 275MBq/kg body weight."

Trial status • Brain Cancer • CNS Tumor • Neuroblastoma • Oncology • Solid Tumor

67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk, Relapsed, Refractory Neuroblastoma (clinicaltrials.gov) - P1/2 | N=34 | Recruiting | Sponsor: Clarity Pharmaceuticals Ltd | Trial completion date: Sep 2022 ➔ Dec 2028 | Trial primary completion date: Sep 2022 ➔ Dec 2028

Trial completion date • Trial primary completion date • Neuroblastoma • Oncology • Pediatrics • Solid Tumor

New PET Radiotracers for the Imaging of Neuroendocrine Neoplasms. (PubMed, Curr Treat Options Oncol) - "In recent years, however, several new tracers were designed exploiting the many potential targets of the neuroendocrine cell and were employed in clinical trials for both imaging and therapy. Currently, the real-life clinical impact of these tracers is still mostly not known; however, the favourable biodistribution (e.g. [68Ga]Ga-FAPI, SSTR antagonists) and the possibility to use new theranostic pairs may provide novel diagnostic as well as therapeutic options (e.g. [68Ga]Ga-PSMA, [64Cu]Cu-SARTATE, [68Ga]Ga-CXCR4) for NEN patients."

Journal • Review • Endocrine Cancer • Neuroblastoma • Neuroendocrine Tumor • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Medullary Carcinoma • CXCR4 • SSTR

First patient treated in cohort 2 SARTATE neuroblastoma therapy trial (PRNewswire) - "Clarity Pharmaceuticals...is pleased to announce that it has successfully treated its first participant in cohort 2 of the 64Cu/67Cu SARTATE™ neuroblastoma therapy trial (CL04) at the increased dose level of 175MBq/kg body weight....Clarity has recently progressed to cohort 2 of the CL04 trial following the completion of cohort 1 where three participants received therapy with 67Cu SARTATE™ at a dose of 75MBq/kg body weight. The Safety Review Committee assessed the data from cohort 1 where no dose limiting toxicities have occurred and recommended to progress the trial to cohort 2, without modification, increasing the dose to 175MBq/kg body weight."

Trial status • Neuroblastoma • Neuroendocrine Tumor • Oncology • Solid Tumor

"#Clarity advances to cohort 2 in the #SARTATE #Neuroblastoma trial $CU6 https://t.co/9TSMU12uIW" (@1stOncology)

Neuroblastoma • Neuroendocrine Tumor • Oncology • Solid Tumor

Clarity and Evergreen enter Targeted Copper Theranostics manufacturing agreement for US Clinical trials (PRNewswire) - "Clarity Pharmaceuticals...and Evergreen Theragnostics, Inc...are pleased to announce that the companies have entered into a Targeted Copper Theranostics (TCTs) manufacturing agreement for Clarity's US clinical trials...Evergreen will centrally manufacture and distribute a range of ready-to-use cGMP TCTs for Clarity's expanding clinical programs across the US from its new state-of-the-art facility in Springfield, New Jersey, USA. These include:...Cu-67 SARTATE™ for Clarity's theranostic neuroblastoma study which is currently underway at multiple sites across the US (NCT04023331); and Cu-64 SAR-Bombesin for Clarity's upcoming clinical trials for this pan-cancer product in the US."

Licensing / partnership • Neuroblastoma • Neuroendocrine Tumor • Oncology

An abbreviated therapy-dosimetric equation for the companion diagnostic/therapeutic [Cu]Cu-SARTATE. (PubMed, EJNMMI Res) - "MRD may be detected by [Cu]Cu-SARTATE and subsequently treated by [Cu]Cu-SARTATE. Since therapeutic dosimetry estimation of the latter agent from the uptake of the former one in the initial diagnostic scan was not addressed, the present theoretical commentary proposes the derivation of an abbreviated therapy-dosimetric equation for the companion diagnostic/therapeutic [/Cu]Cu-SARTATE that might be of interest for future clinical theranostic practice."

Companion diagnostic • Journal • Neuroblastoma • Oncology • Pediatrics • Solid Tumor • SSTR2

"#ClarityPharma expands clinical sites for #SARTATE #Neuroblastoma trial https://t.co/uaYAYbbHLm" (@1stOncology)

Clinical • Neuroblastoma • Neuroendocrine Tumor • Oncology • Solid Tumor

Detection and therapy of neuroblastoma minimal residual disease using [Cu]Cu-SARTATE in a preclinical model of hepatic metastases. (PubMed, EJNMMI Res) - "Clinical experiences of peptide-receptor radionuclide therapy for metastatic disease have been encouraging. This study demonstrates the potential for a theranostic approach using [Cu]Cu-SARTATE for the detection and treatment of SSTR2-positive neuroblastoma MRD."

Journal • Preclinical • Residual disease • Gastrointestinal Cancer • Hepatocellular Cancer • Neuroblastoma • Oncology • Solid Tumor

Clarity Pharmaceuticals Announces the US FDA Grants Rare Paediatric Disease Designation to 64Cu-SARTATE, a diagnostic for the clinical management of neuroblastoma (PRNewswire) - "Clarity Pharmaceuticals...is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Rare Paediatric Disease Designation (RPDD) to 64Cu-SARTATE™, a diagnostic for the clinical management of neuroblastoma."

FDA event • Neuroblastoma • Neuroendocrine Tumor • Oncology

Clarity Pharmaceuticals opens SARTATE neuroblastoma clinical trial (PRNewswire) - "Clarity Pharmaceuticals…is pleased to announce that it has opened its trial of 67Cu-SARTATE™ for paediatric patients with neuroblastoma at Memorial Sloan Kettering Cancer Center (MSK) in New York City and recruitment has commenced….67Cu-SARTATE™ trial is a Peptide Receptor Radionuclide Therapy (PRRT) administered to paediatric patients with high-risk neuroblastoma. It is a multi-centre, dose-escalation, open label, non-randomised, Phase 1/2a theranostic clinical trial at MSK."

Enrollment open • Neuroblastoma • Oncology

67Cu-SARTATE™ Peptide Receptor Radionuclide Therapy Administered to Pediatric Patients With High-Risk Neuroblastoma (clinicaltrials.gov) - P1/2; N=34; Recruiting; Sponsor: Clarity Pharmaceuticals Ltd; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Neuroblastoma • Oncology • Pediatrics • Solid Tumor

An Imaging Study of 64Cu-SARTATE Using Positron Emission Tomography in Patients With Neuroendocrine Tumours (clinicaltrials.gov) - P1; N=10; Completed; Sponsor: Clarity Pharmaceuticals Ltd

Clinical • New P1 trial • Neuroendocrine Tumor • Oncology • Solid Tumor

Clarity Pharmaceuticals announces that the US FDA grants Rare Pediatric Disease Designation to 67Cu-SARTATE for the treatment of neuroblastoma (PRNewswire.co.uk) - "Clarity Pharmaceuticals...is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to 67Cu-SARTATE™, a therapy for the clinical management of neuroblastoma....'We are very excited about the development of SARTATE™ in neuroblastoma and are looking forward to the results from our US-based Phase 1/2 trial.'"

FDA event • P1/2 data • Neuroblastoma • Neuroendocrine Tumor • Oncology

Peptide Receptor Radionuclide Therapy Administered to Participants With Meningioma With 67Cu-SARTATE™ (clinicaltrials.gov) - P1/2; N=5; Completed; Sponsor: Clarity Pharmaceuticals Ltd; Terminated ➔ Completed

Clinical • Trial completion • Brain Cancer • Chronic Kidney Disease • CNS Tumor • Meningioma • Oncology • Renal Disease • Solid Tumor

Clarity Pharmaceuticals announces US FDA grants 67Cu-SARTATE Orphan Drug Designation for neuroblastoma (PRNewswire) - "Clarity Pharmaceuticals....is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for 67Cu-SARTATE™, a therapy for the clinical management of neuroblastoma."

Orphan drug • Neuroblastoma • Neuroendocrine Tumor • Oncology • Solid Tumor

First-in-human trial of Cu-SARTATE PET imaging of patients with neuroendocrine tumours demonstrates high tumor uptake and retention, potentially allowing prospective dosimetry for peptide receptor radionuclide therapy. (PubMed, J Nucl Med) - "Cu-SARTATE is safe and has excellent imaging characteristics. High late-retention in tumour and clearance from the liver suggests suitability for diagnostic studies as well as for prospective dosimetry for Cu-SARTATE PRRT, while the half-life of Cu would also facilitate GMP production and distribution to sites without access to Ga."

Clinical • Journal • P1 data

Peptide Receptor Radionuclide Therapy Administered to Participants With Meningioma With 67Cu-SARTATE™ (clinicaltrials.gov) - P1/2; N=5; Terminated; Sponsor: Clarity Pharmaceuticals Ltd; Trial completion date: Jul 2020 ➔ Sep 2019; Active, not recruiting ➔ Terminated; Trial primary completion date: Jul 2020 ➔ Sep 2019; The study was closed early due to poor recruitment.

Clinical • Trial completion date • Trial primary completion date • Trial termination