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Lu-177 DOTATATE + Cabozantanib in NETs << Back Study of Cabozantinib With Lu-177 in Patients With Somatostatin Receptor 2 Positive Neuroendocrine Tumors CLINICALTRIALS.GOV IDENTIFIER: NCT05249114 DRUG/TREATMENT: Cabozantinib with Lu-177 DOTATATE administration IV PHASE: 1b STATUS: Recruiting SPONSORS: Providence Health & Services COLLABORATORS: Advanced Accelerator Applications SA & Exelixis Dr. Kennecke discusses Cabozantinib with Lu-177 DOTATATE DESCRIPTION: The phase I objective of this study is to establish the maximal tolerated dose (MTD) of cabozantinib in 20 mg, 40 mg and 60 mg dose escalation cohorts in combination with Lu-177 dotatate at a standard dose of 7.4 GBq in four (4) 8-week cycles followed by continuation cabozantinib. READ: 2023 NANETS Abstract, 10/12/2023 For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. PRINCIPAL INVESTIGATOR: Hagen Kennecke, MD, MHA Providence Health & Services CONTACT: Mary McCormick, RN EMAIL: mary.mccormick@providence.org PHONE: 503-215-9570

SORENTO™: Subcutaneous Octreotide for GEP-NETs (CAM2029) << Back SORENTO ™ - A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NETs CLINICALTRIALS.GOV IDENTIFIER: NCT05050942 DRUG/TREATMENT: CAM2029, octreotide LAR, lanreotide ATG PHASE: 3 STATUS: Recruiting SPONSOR: Camurus AB Dr. Simron Singh Discusses the SORENTO™ Trial DESCRIPTION: Camurus is sponsoring a phase 3 study to compare the effectiveness and safety of CAM2029 to octreotide LAR or lanreotide ATG in patients with advanced, well-differentiated GEP-NET. Patients who experience progressive disease in the randomized part of the study may proceed to an open-label extension part with intensified treatment with CAM2029. For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. CONTACT: Camurus AB EMAIL: medicalinfo@camurus.com PHONE: +46 46 286 57 30 Principal Investigator: Simron Singh, MD, MPH Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors and Carcinomas << Back Antibody Drug Conjugate ADCT-701 in Neuroendocrine Tumors and Carcinomas IDENTIFIER ( ClinicalTrials.gov ) : NCT06041516 DRUG/TREATMENT : ADCT-701 is given through a tube attached to a needle inserted into a vein in the arm. PHASE : First-in-Human Phase I Trial STATUS : Recruiting SPONSOR : National Cancer Institute (NCI) DESCRIPTION: This is a first in human phase 1 study to test a new drug, ADCT-701, in people with Neuroendocrine neoplasms (NENs). ADCT-701 is an antibody drug conjugate (or ADC) that specifically targets "Delta Like Non-Canonical Notch Ligand 1" or DLK1, an antigen which has recently been found to be expressed on neuroendocrine cancers. The hope is this drug will suppress tumor growth, shrink tumors after tumor growth, and improve survival. *Note: This study includes all neuroendocrine neoplasms including neuroendocrine tumors, neuroendocrine carcinomas (i.e. "high grade neuroendocrine cancers"), pheochromocytoma, paraganglioma and adrenocortical carcinoma (ACC). For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. CONTACT : National Cancer Institute Medical Oncology Kimberley J Cooper EMAIL: kimberley.cooper@nih.gov PHONE: 240-858-5798 Principal investigator: Jaydira Del Rivero, M.D.,National Cancer Institute (NCI) LOCATIONS : National Instititues of Health Clinical Center: Bethesda, Maryland, United States 20892

Alpha PRRT with Ac-225 + Standard of Care in SSTR+ SCLC << Back Study of RYZ101 in Combination with SoC in Subjects with SSTR+ ES-SCLC IDENTIFIER ( ClinicalTrials.gov ) : NCT05595460 DRUG/TREATMENT : ALPHA PRRT with 225Ac-DOTATATE Actinium 225 radiolabeled somatostatin analog (SSA) for injection + Carboplatin + Etoposide + Atezolizumab PHASE : 1b STATUS : Recruiting SPONSOR : RayzeBio, Inc. DESCRIPTION: Dr. Aman Chauhan at Sylvester Comprehensive Cancer Center, University of Miami discusses the "Alpha PRRT with Ac-225 + Standard of Care in SSTR+ SCLC ." Recorded: June 20, 2024 RayzeBio is sponsoring this phase 1b trial with ALPHA PRRT with 225Ac-DOTATATE for extensive stage small cell lung cancer (ES-SCLC). This trial studies the safety and dosimetry to determine the safety, preliminary antitumor activity, and pharmacokinetics (PK) of RYZ101 ( ALPHA PRRT with 225Ac-DOTATATE Actinium 225 radiolabeled somatostatin analog (SSA) in combination with standard of care (SoC) therapy consisting of carboplatin + etoposide + atezolizumab in untreated subjects with somatostatin receptor expressing (SSTR+) ES-SCLC. For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. CONTACT : RayzeBio Clinical Trials EMAIL: clinicaltrials@rayzebio.com PHONE: 619-657-0302

Lu-177 DOTATATE + Sunitinib in PNETs << Back Testing the Addition of Sunitinib Malate to Lutetium Lu 177 Dotatate (Lutathera) in Pancreatic Neuroendocrine Tumors IDENTIFIER ( ClinicalTrials.gov ) : NCT05687123 DRUG/TREATMENT : Lu177 dotatate + sunitinib study PHASE : 1 STATUS : Recruiting SPONSOR : National Cancer Institute (NCI) DESCRIPTION: This phase I trial tests the safety, side effects, and dosimetry of sunitinib malate in combination with lutetium Lu 177 dotatate in treating patients with pancreatic neuroendocrine tumors. Sunitinib malate is in a class of medications called kinase inhibitors and a form of targeted therapy that blocks the action of abnormal proteins called VEGFRs that signal tumor cells to multiply. This helps stop or slow the spread of tumor cells. Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and not harm normal cells. It is also a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of tumor cells, known as somatostatin receptors, so that radiation can be delivered directly to the tumor cells and kill them. Giving sunitinib malate and lutetium Lu 177 dotatate in combination may be safer and more effective in treating pancreatic neuroendocrine tumors than giving either drug alone. For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. CONTACT : Principal Investigator: Nikolaos Trikalinos,Yale University Cancer Center LAO RELATED RESOURCES Clinical Trials Using Lutetium Lu 177 Dotatate - NCI

ALPHAMEDIX: Alpha PRRT with Pb-212 DOTAMTATE in NETs << Back ALPHAMEDIX - Targeted Alpha-emitter Therapy of PRRT Naive Neuroendocrine Tumor Patients CLINICALTRIALS.GOV IDENTIFIER: NCT05153772 DRUG/TREATMENT: AlphaMedix 212Pb-DOTAMTATE PHASE: 2 STATUS: Recruiting SPONSOR: Radiomedix, Inc. COLLABORATOR: Orano Med LLC Dr. Ebrahim Delpassand Discusses the AlphaMedix Trial (May 9, 2023) Dr. Heloisa Soares Discusses the AlphaMedix Trial (March 10, 2023) DESCRIPTION: Radiomedix is sponsoring a multicenter Phase 2 study of 212Pb-DOTAMTATE enrolling adult subjects with positive somatostatin positive neuroendocrine tumors with no prior history of peptide receptor radionuclide therapy (PRRT naive). In this open-label, multicenter, single-arm Phase 2 study, adult subjects with histologically confirmed NETs and positive somatostatin analog imaging, with no prior PRRT (PRRT naive) will be enrolled to receive 212Pb-DOTAMTATE. For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. CONTACT: Susan Cork EMAIL: scork@exceldiagnostics.com PHONE: 713-341-3203

COMPOSE: PRRT with Lu-177 EDOTREOTIDE versus “Standard of Care” in Well-Differentiated Aggressive G2 & G3 GEP-NETs << Back ITM (COMPOSE) Phase III Clinical Trial: 177 LU-EDOTREOTIDE VS. Best Standard of Care in Well-Differentiated Aggressive G2 & G3 GEP-NETs CLINICALTRIALS.GOV IDENTIFIER: NCT04919226 DRUG/TREATMENT: 177Lu-Edotreotide PRRT (Peptide Receptor Radionuclide Therapy) PRRT versus CAPTEM (Capecitabine and Temozolomide), Everolimus or FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin) PHASE: 3 STATUS: Recruiting SPONSOR: ITM Dr. Heloisa Soares Discusses COMPOSE: PRRT -LU-177 EDOTREOTIDE Dr. Will Pegna Discusses COMPOSE: PRRT - LU-177 EDOTREOTIDE Starting at 9:04 UPDATE (March 2025) The Neuroendocrine Cancer Foundation @NCFCancer (previously @LACNETS) interviews Mayo Clinic Medical Oncologist and #NetCancer expert Dr. Thor Halfdanarson at the 2025 ENETS Annual Medical and Scientific Conference in Krakow, Poland (March 5-7, 2025). Dr. Halfdanarson shares the breaking news of positive results from ITM’s phase 3 COMPETE trial, the first prospective, randomized phase 3 study comparing PRRT with an active treatment (everolimus). DESCRIPTION: ITM is sponsoring “COMPOSE,” an international phase III clinical study to evaluate the efficacy, safety and impact on quality of life of Targeted Radionuclide Therapy (PRRT) with no-carrier-added lutetium-177-edotreotide (n.c.a. 177Lu-edotreotide) compared to a standard therapy with either CAPTEM or everolimus or FOLFOX, in patients with well-differentiated advanced Grade 2 and Grade 3, somatostatin receptor-positive (SSTR+) neuroendocrine tumors of gastroenteric or pancreatic origin (G2 and G3 GEP-NETs). The study is being conducted predominantly in Europe, North America, India and Australia, in approximately 10 countries and 40 sites. For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. CONTACT: Dr. Nicolas Schneider or Amanda Rotger at ITM EMAIL: info-solucin@itm-radiopharma.com

Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) << Back Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) CLINICALTRIALS.GOV IDENTIFIER: NCT05997056 DRUG/TREATMENT: IV PHASE: 2 STATUS: Recruiting SPONSOR: Aadi Bioscience, Inc. DESCRIPTION: Dr. Scott Paulson Discusses the Nab-sirolimus Trial This is a prospective phase 2 single arm, open-label, multi-institutional study to determine the efficacy and safety prospective of nab-sirolimus and patients with functional or non-functional, well-differentiated, locally advanced unresectable in metastatic NETs of the GI tract, lung, or pancreas. For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. CONTACT/Principal Investigator: Aadi Bioscience Medical Information EMAIL: MedInfo@aadibio.com PHONE: 1-888-246-2234 Locations: Recruiting: United States at Texas Oncology in Dallas, Texas 75246 Contact: Christine Terraciano at christine.terraciano@usoncology.com Principal Investigator: Scott Paulson, MD Recruiting: United States at Hoag Memorial Hospital Presbyterian in Newport Beach, California 92663 Contact: Jason Ledesma at jason.ledesma@hoag.org Principal investigator: Michael Demeure, MD Not Yet Recruiting: United States, Denver, Colorado 80218

Lu-177 DOTATATE + Olaparib in GEP-NETs << Back Lu-177-DOTATATE in Combination With Olaparib in Inoperable Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs) CLINICALTRIALS.GOV IDENTIFIER: NCT04086485 DRUG/TREATMENT: Lu-177 DOTATATE + OLAPARIB PHASE I / II STATUS: Recruiting SPONSOR: National Cancer Institute (NCI) Dr. Del Rivero discusses Lu177-Dotatate + OLAPARIB DESCRIPTION: This phase 1-2 trial tests Lu-177-DOTATATE (Lutathera) in combination With olaparib (PARP inhibitor) in inoperable gastroenteropancreatic Neuroendocrine Tumors (GEP-NET). The objective is to learn if people with certain neuroendocrine tumors can take a combination of 2 drugs, Lu-177 DOTATATE and Olaparib, without having severe side effects, and if this treatment makes the tumors shrink. For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. PRINCIPAL INVESTIGATOR: Frank Lin, MD CONTACT: National Cancer Institute Joy Zou, RN EMAIL: joy.zou@nih.gov PHONE: 240-760-6153

Alpha PRRT with Pb-212 VMT << Back Targeted Alpha-Particle Therapy for Advanced SSTR2 Positive Neuroendocrine Tumors (212-Pb-VMT) IDENTIFIER ( ClinicalTrials.gov ) : NCT05636618 DRUG/TREATMENT : Alpha PRRT with 212Pb VMT PHASE : 1 / 2A STATUS : Recruiting SPONSOR : Perspective Therapeutics DESCRIPTION: June 2024: Dr. Aman Chauhan discusses the Alpha PRRT with Pb-212 VMT study. Perspective Therapeutics is sponsoring a phase 1 / 2A 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). During phase 1, there is a dose escalation period testing up to 4 escalating radioactivity dose cohorts of up to 8 subjects (administered at approximately 8-week intervals) at the assigned cohort radioactivity dose. Phase 1 studies the side effects, safety, and dosimetry. For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. CONTACT : Markus Puhlmann, MD, MBA at Perspective Therapeutics EMAIL: mpuhlmann@perspectivetherapeutics.com PHONE: (319) 665-2150

DAREON™-9: DLL-3 BiTE + Topotecan in Small Cell Lung Cancer (SCLC) << Back ! Widget Didn’t Load Check your internet and refresh this page. If that doesn’t work, contact us.

Lu-177 DOTATATE + Triapine in GEP-NETs << Back Phase 2 Trial: Testing the Effectiveness of an Anti-cancer Drug, Triapine, When Used With Targeted Radiation-based Treatment (Lutetium Lu 177 Dotatate), Compared to Lutetium Lu 177 Dotatate Alone for Metastatic Neuroendocrine Tumors DRUG/TREATMENT: LUTATHERA (Lu-177) + Triapine CLINICALTRIALS.GOV IDENTIFIER: NCT05724108 PHASE: 2 STATUS: Recruiting SPONSOR: National Cancer Institute (NCI) June 2024: Dr. Aman Chauhan discusses Phase 2 LUTATHERA (Lu-177) + Triapine study April 2023: Dr. Aman Chauhan discusses Phase 2 LUTATHERA (Lu-177) + Triapine study DESCRIPTION: This phase II trial compares the effect of adding triapine to lutetium Lu 177 dotatate versus lutetium Lu 177 dotatate alone (standard therapy) in shrinking tumors or slowing tumor growth in patients with neuroendocrine tumors that have spread from where they first started (primary site) to other places in the body (metastatic). Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for deoxyribonucleic acid synthesis and cell growth. Lutetium Lu 177 dotatate is a radioactive drug. It binds to a protein called somatostatin receptor, which is found on some neuroendocrine tumor cells. Lutetium Lu 177 dotatate builds up in these cells and gives off radiation that may kill them. It is a type of radioconjugate and a type of somatostatin analog. Giving triapine in combination with lutetium Lu 177 dotatate may be more effective at shrinking tumors or slowing tumor growth in patients with metastatic neuroendocrine tumors than the standard therapy of lutetium Lu 177 dotatate alone. For more information on eligibility criteria, trial locations, study details, etc., go to ClinicalTrials.gov to view this trial here. CONTACT/Principal Investigator: Aman Chauhan, MD EMAIL: axc3268@med.miami.edu RELATED RESOURCES Clinical Trials Using Lutetium Lu 177 Dotatate - NCI Dr. Chauhan's presentation slides can be downloaded here: Dr. Chauhan Presentation on Lu-177 DOTATATE + Triapine Trial .pptx Download PPTX • 16.18MB 2023 NANETS Abstract shows the combination of Triapine and Lu-177 DOTATATE was safe with preliminary efficacy signals.