The goal of this study is to propose the first direct comparison of Ga-68-DOTATATE PET/CT or PET/MR and Ga-68-DOTATOC PET/CT in patients with meningioma.

开始日期2025-03-01

申办/合作机构

Weill Medical College of Cornell University

[+1]

NCT06611891

/ Recruiting临床3期IIT

Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer

DOTABREAST: Evaluation of Somatostatin Receptor Expression in PET 68Ga-DOTATOC in Patients Followed for Metastatic Breast Cancer
This is a prospective, monocentric, non-controlled, non-randomized, open-label, interventional study.

开始日期2025-01-06

申办/合作机构

Centre Hospitalier Universitaire de Grenoble

NCT06256705

/ RecruitingN/AIIT

Multi-modal Characterisation of Gastroenteropancreatic Neuroendocrine Tumours (GEP-NETs) Treated with Targeted Radionuclide Therapy (TRT): Prospective Interventional Multicentre National Cohort

Operandi project aims to address unmet clinical needs in the current management of GEP-NETs treated with PRRT by exploring new opportunities provided by imaging-based (AI algorithms) and data augmentation, simultaneous 68Ga-DOTATOC PET-MRI imaging, and novel approaches to increase patient selection and PRRT efficacy (genomic profiling, radiopotentiators, and new radionuclides). The study aim to identify predictive and early markers indicative of PRRT effectiveness based on a large prospective cohort of GEP-NET patients. This cohort will be used to uncover relevant predictive signatures within the morphological, functional, and molecular imaging data using novel imaging-based AI approaches with a new patient imaging pathway including simultaneous 68Ga-DOTATOC PET-MRI.
Considering this global objective, the objective of this clinical research protocol is to provide clinical, molecular and imaging data in a prospective standardized study, notably by performing systematic PET-MRI at baseline, at mid course of PRRT and 1 year after PRRT initiation, in patients with advanced GEP-NETs treated with PRRT.

开始日期2024-03-25

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

100 项与镓[68Ga]伊索曲肽相关的临床结果

登录后查看更多信息

100 项与镓[68Ga]伊索曲肽相关的转化医学

登录后查看更多信息

100 项与镓[68Ga]伊索曲肽相关的专利（医药）

登录后查看更多信息

352

项与镓[68Ga]伊索曲肽相关的文献（医药）

2025-01-20·Theranostics

First-in-human study of an optimized, potential kit-type, SSTR antagonist ⁶⁸Ga-DATA^5m-LM4 in patients with metastatic neuroendocrine tumors

Article

作者: Rösch, Frank ; Greifenstein, Lukas ; Baum, Richard P ; Mueller, Corinna ; Zan, Elcin ; Landvogt, Christian ; Zhang, Jingjing ; Klega, Andre ; Jakobsson, Vivianne

Radiolabeled somatostatin receptor (SSTR) agonists ⁶⁸Ga-DOTA-TATE and ⁶⁸Ga-DOTA-TOC are widely applied for imaging of patients with neuroendocrine tumors (NETs). Preclinical and preliminary clinical evidence has indicated that SSTR antagonists perform better for NET imaging. In this study, we assessed the feasibility of using a new hybrid chelator DATA^5m ((6-pentanoic acid)-6-(amino)methyl-1,4-diazepinetriacetate))-conjugated kit-type SSTR antagonist ⁶⁸Ga-DATA^5m-LM4 for PET and evaluated the safety, biodistribution, and preliminary diagnostic efficacy of ⁶⁸Ga-DATA^5m-LM4 in patients with metastatic NETs. Methods: The DATA^5m-conjugated form of LM4, was labeled with ⁶⁸Ga. A total of 27 patients (19 men/8 women; mean age 61 years) with histopathologically confirmed well-differentiated NETs underwent ⁶⁸Ga-DATA^5m-LM4 PET/CT for the staging and restaging or patient selection for PRRT. All the patients underwent PET/CT scans 60 min after intravenous bolus injection of 1.85 MBq (0.05 mCi) per kilogram of body weight (151 ± 54 MBq mean ± SD) of ⁶⁸Ga-DATA^5m-LM4. Results: DATA5m-LM4 was successfully labeled with ⁶⁸Ga, achieving high yield and purity. After decay correction, radiochemical yields (RCYs) of 80-95% and radiochemical purities (RCP) greater than 98% were obtained. ⁶⁸Ga -DATA^5m-LM4 was well tolerated in all patients, without clinically relevant adverse effects. A significantly lower uptake in normal liver parenchyma was observed with ⁶⁸Ga-DATA^5m-LM4 compared to ⁶⁸Ga-DOTA-TATE PET/CT (3.90 ± 0.88 vs. 9.12 ± 3.64, P < 0.000001). Additionally, uptake in the thyroid gland, pancreas, and spleen was also lower (P < 0.05). 14 patients underwent ⁶⁸Ga-DOTA-TOC PET/CT. ⁶⁸Ga-DATA^5m-LM4 uptakes in the liver and spleen were significantly lower than those of ⁶⁸Ga-DOTA-TOC uptake (3.70 ± 0.79 vs. 5.33 ± 2.43, P = 0.0397; 11.88 ± 6.88 vs. 26.55 ± 16.07, P = 0.0022). Tumor lesions showed high uptake intensity on ⁶⁸Ga-DATA^5m-LM4 PET/CT, with the highest SUVmax up to 167.93 (mean ± SD, 44.47 ± 36.22). With SUVmean of healthy liver, kidneys, and blood pool as background to normalize the SUVmax of the single most intense lesion, tumor-to-background ratios were 20.32 ± 19.97 (range, 3.40 - 98.78) and 4.30 ± 3.03 (range, 0.65 - 14.70), 38.63 ± 35.97 (range, 4.1 - 173.12), respectively. Conclusion: This study demonstrated that the novel SSTR antagonist ⁶⁸Ga-DATA^5m-LM4 can be efficiently labeled with high radiochemical yield and purity, supported by a highly convenient production process. The tracer exhibited excellent imaging performance, with a highly favorable biodistribution characterized by high tumor contrast and minimal uptake in normal organs, particularly the liver, enabling superior lesion detection. The practical advantages of this straightforward labeling process, achieved without any apparent loss in diagnostic efficacy, offer a significant benefit over other competing antagonists. The ease of production, including the potential for a "kit-type" labeling method, makes ⁶⁸Ga-DATA^5m-LM4 an overall extraordinarily promising radiopharmaceutical for the staging and restaging of NET patients.

2025-01-01·European Journal of Nuclear Medicine and Molecular Imaging

Survival impact of [225Ac]Ac-DOTATOC alpha-therapy in a preclinical model of pancreatic neuroendocrine tumor liver micrometastases

Article

作者: Gaschet, Joëlle ; Gouard, Sébastien ; Chocteau, Florian ; Marionneau-Lambot, Séverine ; Esnault, Mathilde ; Faivre-Chauvet, Alain ; Chérel, Michel ; Morgenstern, Alfred ; Chouin, Nicolas ; Frampas, Éric ; Lugat, Alexandre ; Kraeber-Bodéré, Françoise ; Ansquer, Catherine ; Bourgeois, Mickaël ; Bruchertseifer, Frank

Although peptide radionuclide therapy (PRRT) using a somatostatin analog (SSA) radiolabeled with a beta- emitter: [¹⁷⁷Lu]Lu-DOTATATE has shown a good clinical efficacy in neuroendocrine tumors (NETs), most of the patients only achieved tumoral stabilization and rare but severe long-term hematological toxicities have been reported. One of the promising options to improve PRRT is targeted alpha therapy. It is therefore essential to propose animal models that can mimic systemic spread disease, especially microscopic disease such as early stage of NET liver metastases to explore targeted alpha therapy. Herein, we report the evaluation of efficacy and toxicity of [²²⁵Ac]Ac-DOTATOC in an original preclinical murine model simulating the development of well-characterized liver metastases of pancreatic NETs with SSTR overexpression.METHODSA mouse model of liver metastases of pancreatic NETs was developed by intraportal injection of AR42J cells and explored using [⁶⁸ Ga]Ga-DOTATOC and [¹⁸F]F-FDG PET/MRI. Biodistribution study and radiation dosimetry of [²²⁵Ac]Ac-DOTATOC were determined in subcutaneous tumor-bearing NMRI-nude mice. Efficacy and toxicity were determined by intravenous injection of increasing activities of [²²⁵Ac]Ac-DOTATOC 10 days after intraportal graft.RESULTSLiver tumors showed a high uptake of [⁶⁸ Ga]Ga-DOTATOC and no uptake of [¹⁸F]F-FDG confirming the well-differentiated phenotype. All groups treated with [²²⁵Ac]Ac-DOTATOC showed a significant increase in overall survival compared with DOTATOC-treated mice, especially those treated with the highest activities: 53 days with 240 kBq (p = 0.0001), and 58 days with 2 × 120 kBq (p < 0.0001) vs 28 days with non-radiolabeled DOTATOC. On blood tests, a transient and moderate decreased in white blood cells count after treatment and no severe hepatic or renal toxicity were observed after treatment which was consistent with pathological and radiation dosimetry findings.CONCLUSION[²²⁵Ac]Ac-DOTATOC exhibit a favorable efficacy and toxicity profile in a mouse model of liver micrometastatic pancreatic NET.

2024-07-01·Annals of Surgical Oncology

Radio-Guided Surgery with a New-Generation β-Probe for Radiolabeled Somatostatin Analog, in Patients with Small Intestinal Neuroendocrine Tumors

Article

作者: Morganti, Silvio ; Mirabelli, Riccardo ; Pisa, Eleonora ; Ferrari, Mahila E ; Fazio, Nicola ; Mattana, Francesco ; Bertani, Emilio ; Collamati, Francesco ; Bagnardi, Vincenzo ; Fumagalli Romario, Uberto ; Ceci, Francesco ; Frassoni, Samuele

BACKGROUNDRadio-guided surgery (RGS) holds promise for improving surgical outcomes in neuroendocrine tumors (NETs). Previous studies showed low specificity (SP) using γ-probes to detect radiation emitted by radio-labeled somatostatin analogs.OBJECTIVEWe aimed to assess the sensitivity (SE) and SP of the intraoperative RGS approach using a β-probe with a per-lesion analysis, while assessing safety and feasibility as secondary objectives.METHODSThis prospective, single-arm, single-center, phase II trial (NCT05448157) enrolled 20 patients diagnosed with small intestine NETs (SI-NETs) with positive lesions detected at ⁶⁸Ga-DOTA-TOC positron emission tomography/computed tomography (PET/CT). Patients received an intravenous injection of 1.1 MBq/Kg of 68Ga-DOTA-TOC 10 min prior to surgery. In vivo measurements were conducted using a β-probe. Receiver operating characteristic (ROC) analysis was performed, with the tumor-to-background ratio (TBR) as the independent variable and pathology result (cancer vs. non-cancer) as the dependent variable. The area under the curve (AUC), optimal TBR, and absorbed dose for the surgery staff were reported.RESULTSThe intraoperative RGS approach was feasible in all cases without adverse effects. Of 134 specimens, the AUC was 0.928, with a TBR cut-off of 1.35 yielding 89.3% SE and 86.4% SP. The median absorbed dose for the surgery staff was 30 µSv (range 12-41 µSv).CONCLUSIONThis study reports optimal accuracy in detecting lesions of SI-NETs using the intraoperative RGS approach with a novel β-probe. The method was found to be safe, feasible, and easily reproducible in daily clinical practice, with minimal radiation exposure for the staff. RGS might potentially improve radical resection rates in SI-NETs.CLINICAL TRIALS REGISTRATION⁶⁸Ga-DOTATOC Radio-Guided Surgery with β-Probe in GEP-NET (RGS GEP-NET) [NCT0544815; https://classic.CLINICALTRIALSgov/ct2/show/NCT05448157 ].

项与镓[68Ga]伊索曲肽相关的新闻（医药）

2025-03-07

·PipelineReview

ITM Presents Positive Topline Phase 3 COMPETE Trial Data with n.c.a. 177Lu-edotreotide (ITM-11), a Targeted Radiopharmaceutical Therapy, in Patients with Grade 1 or 2 Gastroenteropancreatic Neuroendocrine Tumors at the ENETS 2025 Conference

KRAKOW, Poland I March 6, 2025 I ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today presented positive topline data from its Phase 3 COMPETE trial in patients with Grade 1 or Grade 2 somatostatin receptor (SSTR)-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The trial results demonstrated that n.c.a. 177 Lu-edotreotide (also known as ITM-11 or 177 Lu-edotreotide), a proprietary, synthetic, targeted radiotherapeutic agent, met the primary endpoint and significantly prolonged progression-free survival in patients when compared to everolimus, a standard of care cancer treatment. The data were presented by study investigator Jaume Capdevila, MD, PhD, at the 22 nd Annual European Neuroendocrine Tumor Society (ENETS) 2025 Conference, held in Krakow, Poland from March 5-7, 2025. “ COMPETE is the first pivotal trial comparing a radiopharmaceutical drug candidate to a targeted molecular therapy without the routine use of accompanying somatostatin analogues in this GEP-NET patient population. These data show unequivocal support for 177 Lu-edotreotide’s potential benefit in extending PFS,” said Dr. Capdevila, senior medical oncologist at Vall d’Hebron University Hospital, Barcelona . “ Additionally, 177 Lu-edotreotide’s convenient dosing schedule and favorable safety results reinforce its potential as a compelling new treatment option .” COMPETE is a prospective, randomized, controlled, open-label Phase 3 trial that enrolled 309 patients with inoperable, progressive, Grade 1 or Grade 2 somatostatin receptor-positive neuroendocrine tumors of gastroenteric or pancreatic origin (Ki-67 ≤20%) in Europe, the United States, Australia and South Africa. The study objectives were to evaluate the efficacy and safety of 177 Lu-edotreotide compared to everolimus. 177 Lu-edotreotide is comprised of non-carrier-added (n.c.a.) lutetium-177, a therapeutic β-emitting radioisotope, and edotreotide, a somatostatin receptor agonist. It is the first radiopharmaceutical to be tested in the GEP-NET patient population using non-carrier-added lutetium, which has a higher isotopic purity than carrier-added lutetium. Patients were randomized 2:1 to receive 7.5 GBq of 177 Lu-edotreotide with a nephroprotective amino acid solution every three months for up to four cycles, or everolimus 10 mg daily for up to 30 months, or until disease progression. There were 207 patients on the 177 Lu-edotreotide arm and 102 on the everolimus arm. Dosimetry was used to assess the absorbed dose in tumors compared to that in healthy tissue to enhance safety and efficacy monitoring of the study drug in patients. Topline Clinical Results Summary “ The COMPETE results represent a major step forward in the development of new treatment options for people living with progressive, inoperable GEP-NETs. By extending progression-free survival by almost ten months compared to standard of care in this trial, 177 Lu-edotreotide showed the potential to significantly improve the treatment paradigm for physicians and their patients ,” said Jonathan Strosberg, MD, past president, North American Neuroendocrine Tumor Society and chair, GI Research Program, Moffitt Cancer Center and Research Institute in Tampa, FL . The median overall survival as of January 21, 2025 was 63.4 months for the 177 Lu-edotreotide arm and 58.7 months for the everolimus arm. While not statistically significant, the interim analysis showed a favorable trend for 177 Lu-edotreotide. Patients were permitted to start an alternative therapy after disease progression, potentially confounding the overall survival data. Overall survival data will continue to be updated. 177 Lu-edotreotide was observed to be well-tolerated and there were no unforeseen treatment-emergent adverse events. Additional data, including objective response rate, subgroup analyses, quality of life assessments and dosimetry, are currently being evaluated and expected to be submitted for presentations at future medical meetings. ITM is planning to submit a New Drug Application (NDA) to the FDA in 2025. “ These successful results validate our decision to design a pivotal Phase 3 trial directly comparing a targeted radiopharmaceutical against a targeted molecular therapy in Grade 1/2 GEP-NETS, underscoring our commitment to improving the lives of people living with this challenging cancer ,” said Andrew Cavey, MD, PhD, chief executive officer, ITM . “ With this successful readout, 177 Lu-edotreotide becomes the first drug candidate in ITM’s broad portfolio of early- to late-stage radiopharmaceuticals to deliver positive Phase 3 results and progress towards NDA submission and commercial launch preparations. Together, with our global isotopes manufacturing business, robust supply chain, and experienced clinical and commercial team, we believe we are uniquely positioned as a standout leader in the fast-growing radiopharmaceutical industry.” ENETS Oral Presentation Details Title : “Efficacy and safety of [ 177 Lu]Lu-edotreotide vs. everolimus in patients with grade 1 or grade 2 gastroenteropancreatic neuroendocrine tumours: COMPETE phase 3 trial” Date and Time : March 6, 2025; 10:05 am – 10:12 am CET Session and Room Number: Clinical science, Session 1: Theranostics in NENs – Integrating experience for a brighter future; Auditorium Hall (S1) Presenter: Jaume Capdevila, MD, PhD, study investigator and senior medical oncologist at Vall d’Hebron University Hospital, Barcelona Additional n.c.a. 177 Lu-edotreotide Clinical Trials 177 Lu-edotreotide is also being evaluated in a Phase 3 trial (COMPOSE) in patients with well-differentiated, aggressive Grade 2 or Grade 3, SSTR-positive GEP-NET tumors. The COMPOSE trial is a prospective, randomized, controlled, open-label trial evaluating the efficacy, safety and patient-reported outcomes of 177 Lu-edotreotide as first- or second-line treatment compared to physician’s choice standard of care chemotherapy. Additional clinical programs with 177 Lu-edotreotide include a Phase 1 pediatric trial in SSTR-positive tumors (KinLET) and a Phase 3 investigator-sponsored trial in lung and thymus neuroendocrine tumors (LEVEL). About GEP-NETS Neuroendocrine tumors (NETs) are a rare form of cancer, with an estimated 8 new cases per 100,000 individuals diagnosed each year in the U.S. and 9 cases per 100,000 in Europe. The incidence of NETs has steadily increased over recent decades, resulting, in part, from improved diagnosis. Gastroenteropancreatic neuroendocrine tumors (GEP-NETS) originate in the neuroendocrine system and are made up of nerve cells and hormone-producing cells. They can occur anywhere in the GI tract and pancreas, including the stomach, small intestine, colon, rectum, and appendix. There is still a high unmet medical need for treatment options, as many patients are asymptomatic and diagnosed at a late stage with metastatic disease. About n.c.a. 177 Lu-edotreotide 177 Lu-edotreotide is a radiolabeled peptide conjugate that delivers beta radiation specifically to SSTR-positive tumor cells, sparing healthy organs and tissue. The drug candidate, delivered intravenously, is comprised of non-carrier-added lutetium-177, a therapeutic β-emitting radioisotope, and edotreotide, a synthetic SSTR agonist. 177 Lu-edotreotide was granted orphan drug designation in the EU and the US, and fast track designation in the US for the treatment of GEP-NETs, based on positive results from a retrospective Phase 2 study with 177 Lu-edotreotide. About ITM Isotope Technologies Munich SE ITM, a leading radiopharmaceutical biotech company, is dedicated to providing a new generation of radiopharmaceutical therapeutics and diagnostics for hard-to-treat tumors. We aim to meet the needs of cancer patients, clinicians and our partners through excellence in development, production and global supply. With improved patient benefit as the driving principle for all we do, ITM advances a broad precision oncology pipeline, including multiple Phase 3 studies, combining the company’s high-quality radioisotopes with a range of targeting molecules. By leveraging our two decades of pioneering radiopharma expertise, central industry position and established global network, ITM strives to provide patients with more effective targeted treatment to improve clinical outcomes and quality of life. www.itm-radiopharma.com References: SOURCE: ITM Isotope Technologies Munich

临床结果临床3期孤儿药快速通道临床2期

2025-03-06

·药明康德

创新多肽偶联药物达3期临床主要终点，今年递交新药申请

▎药明康德内容团队编辑 ITM Isotope Technologies公司今日发布了其专有的靶向放射性疗法177Lu-edotreotide（亦称ITM-11），在治疗无法手术切除的进展性1级或2级胃肠胰神经内分泌肿瘤（GEP-NETs）患者的3期临床试验COMPETE中获得的积极结果。数据显示，与活性对照相比，177Lu-edotreotide显著提高患者的无进展生存期（PFS）。基于这些积极数据，该公司计划在今年递交新药申请（NDA）。 COMPETE是一项前瞻性、随机、含活性对照、开放标签的3期临床试验，旨在评估177Lu-edotreotide与依维莫司（everolimus）这一标准治疗方案相比的疗效和安全性。177Lu-edotreotide由镥177（一种发射β射线的放射性同位素）和edotreotide组成。Edotreotide是一种生长抑素受体（SSTR）激动剂。试验数据显示，177Lu-edotreotide组的中位PFS为23.9个月，而活性对照组这一数值为14.1个月，（HR=0.67，95% CI，0.48-0.95，p=0.022）。此外，与活性对照组相比，177Lu-edotreotide组与研究药物相关的不良事件（TEAE）发生率较低（82.5%比97.0%）。报告有1例与177Lu-edotreotide相关的2级严重TEAE——骨髓增生异常综合征，未发现意外的不良事件。神经内分泌肿瘤是一种罕见的癌症，GEP-NETs起源于神经内分泌系统，由神经细胞和激素分泌细胞组成。GEP-NETs可发生在胃肠道和胰腺的任何部位，包括胃、小肠、结肠、直肠和阑尾。由于许多患者无症状并在晚期出现转移性疾病时才被确诊，治疗选择仍存在巨大未满足的医疗需求。 177Lu-edotreotide是一种放射性同位素标记的肽偶联药物，能够将β射线靶向递送至SSTR阳性肿瘤细胞中，同时避免对健康器官和组织的损伤。基于一项回顾性2期研究的积极结果，它已获得欧盟和美国的孤儿药资格，并在美国获得治疗GEP-NETs的快速通道资格。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] ITM Presents Positive Topline Phase 3 COMPETE Trial Data with n.c.a. 177Lu-edotreotide (ITM-11), a Targeted Radiopharmaceutical Therapy, in Patients with Grade 1 or 2 Gastroenteropancreatic Neuroendocrine Tumors at the ENETS 2025 Conference. Retrieved March 6, 2025, from https://www.globenewswire.com/news-release/2025/03/06/3037982/0/en/ITM-Presents-Positive-Topline-Phase-3-COMPETE-Trial-Data-with-n-c-a-177Lu-edotreotide-ITM-11-a-Targeted-Radiopharmaceutical-Therapy-in-Patients-with-Grade-1-or-2-Gastroenteropancre.html 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

孤儿药临床2期临床3期放射疗法临床结果

2025-03-06

·FierceBiotech

ITM shares details of radiopharma\'s phase 3 win, reveals overall survival miss

When it came to the secondary endpoint of interim overall survival, the ITM-11 cohort reached 63.4 months while the everolimus group was not far behind at 58.7 months.\n ITM Isotope Technologies has provided more detail on how its lead radiotherapy bested the standard of care in a recent phase 3 study while revealing that the candidate was unable to prove a statistically significant benefit in median overall survival.The therapy, dubbed ITM-11, consists of a therapeutic β-emitting radioisotope called lutetium-177 along with a somatostatin receptor (SSTR) agonist called edotreotide. ITM already announced in January that a phase 3 study of 309 patients with SSTR-positive neuroendocrine tumors of the stomach or pancreas had shown that ITM-11 met the primary endpoint of prolonging progression-free survival (PFS) when compared to everolimus.Now, ITM is providing details of that phase 3 win—while acknowledging that another survival endpoint wasn’t quite as successful.Median PFS was “significantly longer” for ITM-11, at 23.9 months, compared to 14.1 months seen by the everolimus cohort, the radiopharma explained. Everolimus, which has been sold by Novartis as Afinitor, is a targeted molecular therapy approved for advanced neuroendocrine tumors and other indications. But when it came to the secondary endpoint of interim overall survival (OS), the ITM-11 cohort reached 63.4 months while the everolimus group was not far behind at 58.7 months. This gap was “numerically higher” but not statistically significant, the company admitted in its data release. To help explain this finding, ITM pointed out that patients had been permitted to start an alternative therapy after disease progression, which “potentially confound[ed] the overall survival data.”When it came to safety, 82.5% of the ITM-11 cohort experienced treatment-emergent adverse events compared to 97% of those who received everolimus. One grade 2 serious event of myelodysplastic syndrome was reported as related to ITM-11, the company said.After 20 years of building radioisotope expertise as a manufacturer and supplier, the German company has been pushing its own therapies into the clinic, with ITM-11 leading the charge. The company also has a phase 1 trial in children with SSTR-positive tumors ongoing, as well as a phase 3 study in lung and thymus neuroendocrine tumors.“These successful results validate our decision to design a pivotal phase 3 trial directly comparing a targeted radiopharmaceutical against a targeted molecular therapy … underscoring our commitment to improving the lives of people living with this challenging cancer,” ITM’s CEO Andrew Cavey, M.D., Ph.D., said in a release.“With this successful readout, [ITM-11] becomes the first drug candidate in ITM’s broad portfolio of early- to late-stage radiopharmaceuticals to deliver positive phase 3 results and progress towards NDA submission and commercial launch preparations,” Cavey added.

$ITM shares details of radiopharma\'s phase 3 win, reveals overall survival miss$

临床3期临床结果临床1期

100 项与镓[68Ga]伊索曲肽相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
-	镓[68Ga]伊索曲肽	V09IX	-

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
神经内分泌肿瘤	美国	UNIV IOWA HOSPS AND CLINICS PET IMAGING CENTER	2019-08-21
SSTR阳性胃肠胰神经内分泌肿瘤	欧盟	Advanced Accelerator Applications SA	2016-12-08
SSTR阳性胃肠胰神经内分泌肿瘤	列支敦士登	Advanced Accelerator Applications SA	2016-12-08
SSTR阳性胃肠胰神经内分泌肿瘤	挪威	Advanced Accelerator Applications SA	2016-12-08
SSTR阳性胃肠胰神经内分泌肿瘤	冰岛	Advanced Accelerator Applications SA	2016-12-08
胃肠胰神经内分泌肿瘤	-	Itm Isotope Technologies Munich SE	-

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
胃肠胰神经内分泌肿瘤	临床3期	-	江苏恒瑞医药股份有限公司	2023-11-01
细菌性心内膜炎	临床2期	法国	Centre Hospitalier Regional de Nancy	2022-05-16
类癌	临床1期	美国	University of Iowa	2015-09-01
生长抑素瘤	临床1期	美国	Icahn School of Medicine at Mount Sinai	2014-12-01
类癌	药物发现	美国	University of Iowa	2015-09-01
髓母细胞瘤	药物发现	美国	University of Iowa	2015-09-01
神经母细胞瘤	药物发现	美国	University of Iowa	2015-09-01
生长抑素受体阳性神经内分泌肿瘤	药物发现	美国	University of Iowa	2012-02-21

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05448157 (RGS GEP-NET, Pubmed)	临床2期	神经内分泌肿瘤 68Ga-DOTA-TOC	20	68Ga-DOTA-TOC	鹽廠窪鹽觸廠膚齋鏇繭(顧鹽積網鏇網鑰製廠窪) = 鬱窪築夢壓廠願鑰憲蓋餘夢鏇築糧顧鹽襯製願 (艱遞壓鏇廠選願網襯淵 ) 更多	积极	2024-04-23
THU036 (ENDO2023)	N/A	库欣综合征 ACTH	44	68Ga-DOTATOC PET/CT	窪齋範艱範衊顧範齋壓(網觸選鏇夢夢網窪遞鏇) = 鏇願簾網鏇觸範鏇製襯襯廠願簾遞膚鏇顧窪衊 (壓餘壓鏇艱繭齋壓夢夢 ) 更多	不佳	2023-10-05
				68 Ga-DOTATOC (Pituitary MRI)	窪齋範艱範衊顧範齋壓(網觸選鏇夢夢網窪遞鏇) = 齋蓋簾壓衊糧艱膚選獵襯廠願簾遞膚鏇顧窪衊 (壓餘壓鏇艱繭齋壓夢夢 ) 更多
EANM2021	N/A	神经内分泌肿瘤	84	68 Ga-DOTATOC (SRETVwb)	齋壓夢選觸膚憲膚鹹積(構觸鹽糧選選積顧醖選) = 顧醖襯窪獵築艱積構鏇製淵鹹衊獵構築鏇醖淵 (獵鏇遞範選構鏇遞範積 )	-	2021-09-24
				68 Ga-DOTATOC (TLSREwb)	糧憲夢積網網襯構衊蓋(醖鹹願蓋鑰範襯蓋夢齋) = 鹹鏇構網鹹簾繭壓醖築淵鑰鬱蓋廠積願蓋糧憲 (衊廠壓醖淵顧糧窪壓淵 )
NCT01869725 (CTgov)	临床2期	生长抑素瘤 \| 神经母细胞瘤 \| 髓母细胞瘤	68	contrast-enhanced magnetic resonance imaging+indium In 111 pentetreotide+gallium Ga 68-edotreotide	鬱膚構鏇糧鬱築淵選窪(衊齋醖鏇積獵築淵顧齋) = 餘鬱製餘獵壓鹽糧網鬱壓夢顧淵壓淵積齋鹹簾 (蓋鑰範願範顧鹹齋淵衊, 淵餘觸範艱齋構築餘壓 ~ 憲糧範鏇願簾艱積範衊) 更多	-	2021-09-22
SNMMI2021	N/A	-	-	68 Ga-DOTA-TOC (Patients with normal serum glucose level)	憲糧簾顧醖鹹觸網製鹹(壓獵製鹽鹹窪簾壓選壓) = 淵顧餘餘夢選遞製簾鹹廠淵網遞網夢糧鑰憲觸 (顧淵廠製鏇襯遞網顧鹹, 5.238)	-	2021-05-18
NCT01619865 (GA-68, CTgov)	临床1/2期	类癌 \| 神经母细胞瘤 \| 髓母细胞瘤 \| 生长抑素受体阳性神经内分泌肿瘤	223	68Ga-DOTATOC PET/CT	醖遞窪艱構壓構觸鑰獵(鹹憲糧襯鹽鹽膚齋獵壓) = 願廠醖淵網製積製鹽醖餘餘獵顧繭窪鹹醖網遞 (鏇艱齋憲鬱衊夢積網衊, 襯顧願鏇簾觸遞齋夢繭 ~ 糧獵遞夢糧鑰齋壓醖齋) 更多	-	2021-02-02
EANM2020	N/A	副神经节瘤 \| 嗜铬细胞瘤	33	68 Ga-DOTATOC68Ga-DOTATOC (68 Ga-DOTATOC-PET/CT)	艱襯積鹹繭醖製衊範鏇(膚網鏇獵選鹹衊鹽製鏇) = 壓構鏇積遞壓範觸壓醖獵積鏇窪繭獵簾遞廠壓 (夢簾壓醖積憲襯範夢窪 ) 更多	积极	2020-09-18
				18 F-DOPA68Ga-DOTATOC (18 F-DOPA-PET/CT)	艱襯積鹹繭醖製衊範鏇(膚網鏇獵選鹹衊鹽製鏇) = 窪夢憲選糧艱顧糧觸餘獵積鏇窪繭獵簾遞廠壓 (夢簾壓醖積憲襯範夢窪 ) 更多
EANM2019	N/A	神经内分泌肿瘤 68 Ga DOTATOC PET/CT	35	68 Ga DOTATOC PET/CT	積觸構淵願醖壓築繭鹹(顧壓網膚壓範網鹹觸齋) = 築築願遞觸艱糧鏇鏇願襯鹽簾鏇鏇醖夢觸簾鬱 (鏇網築憲鹽鏇製蓋築製 ) 更多	-	2019-09-18
				68 Ga DOTATOC (CT)	積觸構淵願醖壓築繭鹹(顧壓網膚壓範網鹹觸齋) = 鏇製構網網廠窪鹽艱憲襯鹽簾鏇鏇醖夢觸簾鬱 (鏇網築憲鹽鏇製蓋築製 )
NCT03136328 (CTgov)	临床3期	神经内分泌肿瘤	11	68Ga-DOTATOC	壓鏇壓願觸製構鬱鬱淵(觸鹹廠鹹選夢壓壓鹹鏇) = 醖廠衊醖遞鹽鬱願襯齋顧顧鏇壓衊範膚顧選鹽 (膚壓簾鹽觸獵鏇製夢廠, 願顧蓋廠膚膚築簾鹹鬱 ~ 繭壓淵遞簾願壓選壓繭) 更多	-	2019-01-30
SNMMI2018	N/A	-	-	68 Ga-DOTATOC (Galli Eo® 68Ge/68Ga generator)	積選積鏇鹽壓積顧淵憲(鹽鑰遞顧鹹獵壓壓遞繭) = 網鹽顧遞齋構鑰網製積鬱衊糧鬱齋蓋糧範繭憲 (鹽襯鹹齋獵鏇窪築構鹹 ) 更多	-	2018-05-23
				68 Ga-DOTATOC (GRP 3V synthesizer)	積選積鏇鹽壓積顧淵憲(鹽鑰遞顧鹹獵壓壓遞繭) = 顧壓膚鹽醖齋膚遞繭憲鬱衊糧鬱齋蓋糧範繭憲 (鹽襯鹹齋獵鏇窪築構鹹 ) 更多