A Phase 1 Trial for Evaluation of Safety and 177Lu Radiation Dosimetry of CTT1403: A Peptidomimetic Inhibitor of Prostate Specific Membrane Antigen, in Metastatic Castration Resistant Prostate Cancer (mCRPC)

The purpose of this study is to find the highest dose level of study drug, CTT1403, that can be safely administered to patients with metastatic castration resistant prostate cancer (mCRPC).

开始日期2019-04-01

申办/合作机构

Cancer Targeted Technology LLC

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100 项与 CTT-1403 相关的临床结果

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100 项与 CTT-1403 相关的转化医学

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100 项与 CTT-1403 相关的专利（医药）

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项与 CTT-1403 相关的文献（医药）

2026-03-01·NUCLEAR MEDICINE AND BIOLOGY

Development of an automated one-step radiolabeling procedure for a PSMA-targeted radiotherapeutic for prostate cancer

Article

作者: Ho, Khanh-Van ; Ocak, Meltem ; Ling, Xiaoxi ; Simón, Jaime ; Langton-Webster, Beatrice C ; Berkman, Clifford E ; Fulton, Melody D ; Bomba, Hunter N ; Anderson, Carolyn J ; Carroll, Valerie N ; Pun, Michael ; Sikligar, Kanishka

BACKGROUND:

CTT1403 (¹⁷⁷Lu-CTT2001), an irreversible phosphoramidate PSMA inhibitor developed by Cancer Targeted Technology, was initially synthesized using a two-step radiolabeling method and has previously been evaluated in first-in-human studies. This two-step approach protected the phosphoramidate pharmacophore-containing a temperature- and pH-labile PN bond-from the harsh conditions required for lutetium-177 (¹⁷⁷Lu) chelation. Although the final chemical structure of CTT1403 is identical regardless of the radiolabeling route, it was not clear that CTT2001 could tolerate one-step labeling conditions while preserving PSMA-binding integrity. Therefore, the aim of the study was to develop, optimize, and automate a one-step radiolabeling method for CTT1403 and to confirm that the resulting product is biologically equivalent and exhibits comparable in vitro and in vivo behavior to CTT1403 produced by the original two-step process.

METHODS:

CTT2001 was synthesized and radiolabeled with ¹⁷⁷Lu using an optimized one-step procedure that was subsequently automated on a Trasis AllinOne synthesizer. Radiochemical purity, stability, cellular uptake/internalization, and biodistribution in PC3-PIP tumor-bearing mice were evaluated.

RESULTS:

CTT1403 synthesized via the one-step method demonstrated cellular uptake and internalization in PC3-PIP cells, as well as in vivo biodistribution in PC3-PIP tumor-bearing mice, that were comparable to those of the two-step-labeled product. The one-step procedure was successfully automated on the Trasis All-in-One synthesizer, producing CTT1403 with a radiochemical yield of 86.5 ± 4.27% (n = 3), a molar activity of 30.3 ± 1.11 MBq/nmol, and a radiochemical purity of 97.6 ± 0.80% (n = 3) in a total synthesis time of 38 min. The final product remained stable for at least 24 h at -4 °C and -20 °C.

CONCLUSIONS:

The one-step radiolabeling method yields CTT1403 that is biologically equivalent to the two-step product and can be reliably produced using fully automated synthesis. This streamlined, efficient, and reproducible approach supports routine clinical manufacturing of CTT1403.

2020-04-01·Molecular imaging and biology3区 · 医学

Preclinical Dosimetry, Imaging, and Targeted Radionuclide Therapy Studies of Lu-177-Labeled Albumin-Binding, PSMA-Targeted CTT1403

3区 · 医学

Article

作者: Anderson, Carolyn J ; Geruntho, Jonathan J ; Rigatti, Lora H ; Salamacha, Nathan ; Wu, Yijen ; Laymon, Charles M ; Windish, Hillarie P ; Kurland, Brenda F ; Ling, Xiaoxi ; Shen, Ding ; Choy, Cindy J ; Langton-Webster, Beatrice ; Berkman, Clifford E ; Latoche, Joseph D

PURPOSE:

Prostate-specific membrane antigen (PSMA) continues to be the hallmark biomarker for prostate cancer as it is expressed on nearly all prostatic tumors. In addition, increased PSMA expression correlates with castration resistance and progression to the metastatic stage of the disease. Recently, we combined both an albumin-binding motif and an irreversible PSMA inhibitor to develop the novel PSMA-targeted radiotherapeutic agent, CTT1403. This molecule was novel in the field of PSMA-targeted agents as its key motifs resulted in extended blood circulation time and tumor uptake, rapid and extensive internalization into PSMA+ cells, and promising therapeutic efficacy. The objective of this study was to perform IND-enabling translational studies on CTT1403 in rodent models.

PROCEDURES:

A dose optimization study was performed in PC3-PIP (PSMA+) tumor-bearing mice. Treatment groups were randomly selected to receive one to three 14-MBq injections of CTT1403. Control groups included (1) saline, (2) non-radioactive [¹⁷⁵Lu]CTT1403, or (3) two injections of 14 MBq CTT1751, a Lu-177-labeled non-targeted albumin-binding moiety. Tumor growth was monitored up to 120 days. Small-animal single photon emission tomography/X-ray computed tomography imaging was performed with CTT1403 and CTT1751 in PC3-PIP tumor-bearing mice to visualize infiltration of the Lu-177-labeled agent into the tumor. In preparation for a first-in-human study, human absorbed doses were estimated based on rat biodistribution out to 5 weeks to determine a safe CTT1403 therapy dose in humans.

RESULTS:

Two to 3 injections of 14 MBq CTT1403 yielded significant tumor growth inhibition and increased survival compared with all control groups and mice receiving 1 injection of 14 MBq CTT1403. Five of 12 mice receiving 2 or 3 injections of CTT1403 survived to the 120-day post-treatment study endpoint. Dosimetry identified the kidneys as the dose-limiting organ, with an equivalent dose of 5.18 mSv/MBq, resulting in a planned maximum dose of 4.4 GBq for phase 1 clinical trials.

CONCLUSIONS:

The preclinical efficacy and dosimetry of CTT1403 suggest that this agent has significant potential to be safe and effective in humans.

2017-01-01·Theranostics1区 · 医学

¹⁷⁷Lu-Labeled Phosphoramidate-Based PSMA Inhibitors: The Effect of an Albumin Binder on Biodistribution and Therapeutic Efficacy in Prostate Tumor-Bearing Mice

1区 · 医学

ArticleOA

作者: Choy, Cindy J ; Ling, Xiaoxi ; Beyer, Sophia K ; Berkman, Clifford E ; Anderson, Carolyn J ; Latoche, Joseph D ; Langton-Webster, Beatrice ; Geruntho, Jonathan J

Prostate-specific membrane antigen (PSMA) continues to be an active biomarker for small-molecule PSMA-targeted imaging and therapeutic agents for prostate cancer and various non-prostatic tumors that are characterized by PSMA expression on their neovasculature. One of the challenges for small-molecule PSMA inhibitors with respect to delivering therapeutic payloads is their rapid renal clearance. In order to overcome this pharmacokinetic challenge, we outfitted a ¹⁷⁷Lu-labeled phosphoramidate-based PSMA inhibitor (CTT1298) with an albumin-binding motif (CTT1403) and compared its in vivo performance with that of an analogous compound lacking the albumin-binding motif (CTT1401). The radiolabeling of CTT1401 and CTT1403 was achieved using click chemistry to connect ¹⁷⁷Lu-DOTA-N₃ to the dibenzocyclooctyne (DBCO)-bearing CTT1298 inhibitor cores. A direct comparison in vitro and in vivo performance was made for CTT1401 and CTT1403; the specificity and efficacy by means of cellular uptake and internalization, biodistribution, and therapeutic efficacy were determined for both compounds. While both compounds displayed excellent uptake and rapid internalization in PSMA+ PC3-PIP cells, the albumin binding moiety in CTT1403 conferred clear advantages to the PSMA-inhibitor scaffold including increased circulating half-life and prostate tumor uptake that continued to increase up to 168 h post-injection. This increased tumor uptake translated into superior therapeutic efficacy of CTT1403 in PSMA+ PC3-PIP human xenograft tumors.

项与 CTT-1403 相关的新闻（医药）

2026-03-15

·核联盛

一文读懂｜肿瘤放射性配体疗法的全球研发布局图谱

前言放射性配体疗法（RLT）作为肿瘤靶向治疗领域的重要方向，其研发布局与临床进展备受关注。为全面梳理该领域的研发现状，研究截至 2025 年 3 月构建了涵盖69 种商业化临床开发阶段 RLT 的综合数据库，通过多源数据检索、人工交叉核验的严谨方式，系统收录了药物研发主体、放射性核素、靶向基团、作用靶点、肿瘤适应症及试验阶段等核心信息，剔除非符合判定标准的研究对象，确保数据的准确性与完整性。基于该全面且规范的数据库，展开肿瘤放射性配体疗法的研发布局分析，为行业了解 RLT 研发全貌、把握领域发展趋势提供详实参考。原文 The landscape for radioligand therapies in oncology By Jerrick To, Rachel Magid, Jon Cleland, Val Panier & John Wu Nature Reviews Drug Discovery 24, 584-585 (2025) doi: https://doi.org/10.1038/d41573-025-00096-w 肿瘤放射性配体疗法的研发布局-数据库构建与分析截至 2025 年 3 月，我们构建了包含69 种处于商业化临床开发阶段的放射性配体疗法（RLT）的综合数据库。核心数据来源：本研究初始研究对象均从 EvaluatePharma 数据库中筛选得出。我们以“辐射”“放射性核素”“放射性药物” 为关键词，在 EvaluatePharma 总数据库的 “作用机制”“药理分类” 或 “治疗亚类” 字段中进行检索，筛选出相关研究对象。验证过程：我们通过企业官网、企业报告及学术文献，对初步筛选得到的数据库进行人工交叉核验，以此对研究对象进行放射性配体疗法分类。不符合放射性配体疗法判定标准的放射性药物研究对象均被排除，排除标准包括：非全身给药、无明确的配体靶向基团（如 Xofigo / Ra-223、仅基于纳米颗粒或脂质体的制剂）、仅用于诊断目的。开发阶段：已获批研究对象为目前已上市的药物；临床阶段研究对象为当前处于 I-Ⅲ期临床试验的药物，相关信息均来自企业官网和 / 或 ClinicalTrials.gov。对于联合无缝试验（如Ⅰ/Ⅱ 期或 Ⅰ/Ⅲ 期）中的研究对象，我们根据企业披露信息，或结合试验起止时间评估其当前研究节点，将其归至特定试验阶段；处于监管审评阶段的研究对象归为Ⅲ 期。放射性核素：放射性配体疗法研究对象的放射性核素信息均来自企业官网及披露文件。我们根据核素衰变链中产生的更具创新性或临床价值的粒子类型，对放射性核素进行分类。图1中未纳入已在临床验证的前代放射性配体疗法及其他放射性药物中使用的核素（I- 123、I-131、Y- 90）；不同放射性核素对应的临床阶段放射性配体疗法详细分类情况见补充图 1。靶向基团：靶向基团类型依据企业官网或公开文献中的明确分类确定；对于未明确标注靶向基团类型的研究对象，若其化学结构已知，则通过结构分析判定类型。肽类靶向基团依据具有明确结构的多个肽键和氨基酸序列识别，以此与非肽类小分子靶向基团区分。传统抗体指未经过特殊工程改造或修饰的抗体；工程化蛋白及抗体衍生物包括单重链抗体、单域抗体、抗原结合片段（Fabs）、纳米抗体、小蛋白、双特异性抗体及四聚体抗体。作用靶点：放射性配体疗法研究对象的作用靶点信息均来自企业官网及披露文件。基于美国食品药品监督管理局（FDA）的获批信息，我们将靶点分为三类：放射性配体疗法验证靶点、其他疗法验证靶点（已有获批疗法针对该靶点）、探索性靶点（尚无任何获批疗法对其进行验证）。肿瘤类型：各放射性配体疗法研究对象的靶向肿瘤类型信息来自企业官网和ClinicalTrials.gov。对于早期Ⅰ期研究对象，其靶向肿瘤类型通过查阅对应在研试验的入组标准进一步确定（注：多数Ⅰ期研究对象参与的是篮式试验，同时研究多种肿瘤类型）。若靶向肿瘤类型仅基于生物标志物确定（如SSTR2 +肿瘤、FAP+肿瘤），未明确具体肿瘤类型，则标注为“未指定”。在可行的情况下，将肿瘤类型归为更广泛的类别（如“黑色素瘤及皮肤肿瘤”包括黑色素瘤、默克尔细胞癌、葡萄膜黑色素瘤）。新一代技术评估：我们将2000年代获批的放射性配体疗法定义为初代产品（Zevalin / 替伊莫单抗、Bexxar /托西莫单抗及I [131I]托西莫单抗）；近期获批并商业化的放射性配体疗法为现一代产品（Lutathera / Lu [177Lu]奥曲肽、Pluvicto/ Lu [177Lu]维泊妥肽）；临床阶段在研产品则归为新一代放射性配体疗法。我们通过查阅科学文献，评估不同技术的潜在应用价值及面临的挑战。图 1 不同放射性核素对应的临床阶段放射性配体疗法 A.临床阶段放射性配体疗法中使用的放射性核素，按粒子发射类型及获批放射性药物中的临床验证情况分类（I-131、Y- 90、I-123 用于非靶向放射治疗或放射性诊断）。 B.临床阶段放射性配体疗法中主要新型放射性核素的发射粒子及衰变链。标注各放射性核素的半衰期（µs =微秒，ms =毫秒，s =秒，h =小时，d =天）。表 1 商业化临床阶段的放射性配体疗法企业研究对象放射性核素靶向基团作用靶点肿瘤类型试验阶段 Abdera Therapeutics ABD-147 Ac - 225 工程化抗体 / 蛋白 DLL3 肺神经内分泌肿瘤 Ⅰ期 Actinium Iomab-B I - 131 传统抗体 CD45 骨髓清髓 Ⅲ期 Actinium Actimab-A Ac - 225 传统抗体 CD33 急性髓系白血病 Ⅱ期 AdvanCell ADVC001 Pb - 212 非肽类小分子 PSMA 前列腺癌 Ⅰ期 Akysis AKY-1189 Ac - 225 工程化抗体 / 蛋白 Nectin-4 膀胱癌、乳腺癌、非小细胞肺癌、结直肠癌、宫颈癌 Ⅰ期 Ariceum SS0110（Lu-177） Lu - 177 肽类 SSTR2 肺神经内分泌肿瘤 Ⅰ期 Ariceum SS0110（Ac-225） Ac - 225 肽类 SSTR2 肺神经内分泌肿瘤、黑色素瘤及皮肤肿瘤 Ⅰ期 Ariceum ATT001 I - 123 非肽类小分子 PARPi 胶质母细胞瘤 Ⅰ期 ArtBio AB001 Pb - 212 非肽类小分子 PSMA 前列腺癌 Ⅰ期 AstraZeneca FPI-1434 Ac - 225 传统抗体 IGF-1R 子宫内膜癌、宫颈癌、卵巢癌、乳腺癌、头颈部肿瘤、黑色素瘤及皮肤肿瘤 Ⅰ期 AstraZeneca FPI-2068 Ac - 225 工程化抗体 / 蛋白 EGFR/cMET 头颈部肿瘤、非小细胞肺癌、结直肠癌、胰腺癌 Ⅰ期 AstraZeneca FPI-2265 Ac - 225 非肽类小分子 PSMA 前列腺癌 Ⅱ期 Bayer BAY3546828 Ac - 225 传统抗体 PSMA 前列腺癌 Ⅰ期 Bayer BAY3563254 Ac - 225 非肽类小分子 PSMA 前列腺癌 Ⅰ期 Bivision JH020002（JH02）Lu-177 Lu - 177 肽类 PSMA 前列腺癌 Ⅰ期 Blue Earth Therapeutics 177Lu-rhPSMA-10.1 Lu - 177 非肽类小分子 PSMA 前列腺癌 Ⅰ期 Bristol Myers Squibb RYZ801 Ac - 225 肽类 GPC3 肝癌 Ⅰ期 Bristol Myers Squibb RYZ101 Ac - 225 肽类 SSTR2 胃肠胰神经内分泌肿瘤、肺神经内分泌肿瘤、乳腺癌 Ⅲ期 Cancer Targeted Technology CTT1403 Lu - 177 非肽类小分子 PSMA 前列腺癌 Ⅰ期 CellBion 177Lu-PSMA-DGUL Lu - 177 非肽类小分子 PSMA 前列腺癌 Ⅱ期 Clarity 67Cu-SAR-bisPSMA Cu - 67 非肽类小分子 PSMA 前列腺癌 Ⅱ期 Clarity 67Cu-SAR-Bombesin Cu - 67 肽类 GRPR 前列腺癌 Ⅰ期 Clarity 67Cu-SARTATE Cu - 67 肽类 SSTR2 神经母细胞瘤 Ⅰ期 Convergent Therapeutics CONV01-α Ac - 225 传统抗体 PSMA 前列腺癌 Ⅱ期 Curium 177Lu-PSMA I&T Lu - 177 非肽类小分子 PSMA 前列腺癌 Ⅲ期 Eli Lilly PNT2001 Ac - 225 非肽类小分子 PSMA 前列腺癌 Ⅰ期 Eli Lilly PNT6555 Lu - 177 肽类 FAP 胰腺癌、肉瘤、食管癌、结直肠癌、黑色素瘤、头颈部肿瘤、胆管癌 Ⅰ期 FutureChem 177Lu-FC705（Ludotadipep） Lu - 177 小分子 PSMA 前列腺癌 Ⅱ期 GlyTherix 177Lu-Miltuximab Lu - 177 传统抗体 GPC-1 前列腺癌、膀胱癌 Ⅰ期 HengRui HRS-4357 未披露未披露 PSMA 前列腺癌 Ⅱ期 ITM ITM-11 Lu - 177 肽类 SSTR2 胃肠胰神经内分泌肿瘤 Ⅲ期 ITM ITM-23 Tb - 161 非肽类小分子 PSMA 前列腺癌 Ⅰ期 ITM ITM-63 Tb - 161 肽类 SSTR2 胃肠胰神经内分泌肿瘤 Ⅰ期 ITM ITM-31 Lu - 177 工程化抗体 / 蛋白 CAXII 胶质母细胞瘤 Ⅰ期 ITM ITM-91 Lu - 177 肽类 CAIX 肾癌、胰腺癌、结直肠癌 Ⅰ期 J&J JNJ-69086420 Ac - 225 传统抗体 hK2 前列腺癌 Ⅰ期 Lantheus PNT2002 Lu - 177 非肽类小分子 PSMA 前列腺癌 Ⅲ期 Lantheus PNT2003 Lu - 177 肽类 SSTR2 胃肠胰神经内分泌肿瘤 Ⅲ期（已提交上市申请） Modulation MTI-201 Ac - 225 未披露 MC1R 黑色素瘤及皮肤肿瘤 Ⅰ期 Molecular Targeting Technologies 177Lu-EBTATE Lu - 177 肽类 SSTR2 胃肠胰神经内分泌肿瘤、肺神经内分泌肿瘤、甲状腺癌、头颈部肿瘤 Ⅱ期 Monopar MNPR-101-Lu Lu - 177 传统抗体 uPAR 膀胱癌、乳腺癌、肺神经内分泌肿瘤、非小细胞肺癌、结直肠癌、卵巢癌、胰腺癌 Ⅰ期 Novartis Pluvicto Lu - 177 非肽类小分子 PSMA 前列腺癌已上市 Novartis Lutathera Lu - 177 肽类 SSTR2 胃肠胰神经内分泌肿瘤已上市 Novartis AAA817（Ac-PSMA-617） Ac - 225 非肽类小分子 PSMA 前列腺癌 Ⅱ期 Novartis AAA603（177Lu-NeoB） Lu - 177 肽类 GRPR 乳腺癌、胶质母细胞瘤 Ⅱ期 Novartis FXX489（Lu-NNS309） Lu - 177 未披露未披露胰腺癌、非小细胞肺癌、乳腺癌、结直肠癌 Ⅰ期 Novartis AAA614（Lu-FAP-2286） Lu - 177 肽类 FAP 非小细胞肺癌、胰腺癌、乳腺癌 Ⅰ期 Novartis GIZ943（Lu-EVS-459） Lu - 177 未披露 FRα 卵巢癌、非小细胞肺癌 Ⅰ期 Novartis AAA802（225Ac-PSMA-R2） Ac - 225 非肽类小分子 PSMA 前列腺癌 Ⅱ期 Orano Med AlphaMedix Pb - 212 肽类 SSTR2 胃肠胰神经内分泌肿瘤 Ⅱ期 Orano Med 212Pb-GRPR Pb - 212 肽类 GRPR 前列腺癌、乳腺癌 Ⅰ期 PentixaPharm PentixaTher PT-002（Lu-177） Lu - 177 肽类 CXCR4 白血病 Ⅰ期 PentixaPharm PentixaTher PT-002（Y-90）钇 - 90 肽类 CXCR4 淋巴瘤、多发性骨髓瘤 Ⅰ期 Perspective Therapeutics 212pb-VMT-α-NET Pb - 212 肽类 SSTR2 胃肠胰神经内分泌肿瘤 Ⅰ期 Perspective Therapeutics VMT01 Pb - 212 肽类 MC1R 黑色素瘤及皮肤肿瘤 Ⅰ期 Philogen OncoFAP Lu - 177 非肽类小分子 FAP FAP + 实体瘤 Ⅰ期 Precirix CAM-H2 I - 131 工程化抗体 / 蛋白 HER2 乳腺癌、胃癌、胃食管结合部癌 Ⅰ期 Radiopharm Therapeutics RAD204 Lu - 177 工程化抗体 / 蛋白 PD-L1 非小细胞肺癌 Ⅰ期 Ratio Therapeutics N/A Ac - 225 非肽类小分子 FAP 肉瘤 Ⅰ期 Sinotau XTR008（177Lu Oxodotreotide） Lu - 177 肽类 SSTR2 除 G1/G2 级胃肠胰神经内分泌肿瘤外的神经内分泌肿瘤 Ⅱ期 Sinotau XTR010 未披露未披露未披露前列腺癌未披露 Sinotau XTR017 / XT-117 Lu-177 Lu - 177 未披露 FAP 未指定 Ⅰ期 Telix TLX591 Lu - 177 传统抗体 PSMA 前列腺癌 Ⅲ期 Telix TLX250 Lu - 177 传统抗体 CAIX 肾癌 Ⅱ期 Telix TLX101 I - 131 非肽类小分子 LAT-1 胶质母细胞瘤 Ⅱ期 Telix TLX592 Ac - 225 传统抗体 PSMA 前列腺癌 Ⅰ期 Telix TLX66 Y- 90 传统抗体 CD66 骨髓清髓 Ⅱ期 Y-mAbs GD2-SADA Lu - 177 工程化抗体 / 蛋白 GD2 肺神经内分泌肿瘤、黑色素瘤及皮肤肿瘤、肉瘤、神经母细胞瘤 Ⅰ期 Y-mAbs CD38-SADA Lu - 177 工程化抗体 / 蛋白 CD38 非霍奇金淋巴瘤 Ⅰ期

2020-08-07

·cancertargetedtechnology

NIH grants $1.44M to Cancer Targeted Technology to Support the Ongoing Prostate Cancer Clinical Trial of a Promising New Radiotherapeutic, CTT1403

Published: August 07, 2020 09:30 AM Eastern Daylight Time SEATTLE--(BUSINESS WIRE) Cancer Targeted Technology (CTT), a privately-held Seattle-based biotechnology company, announced that the NIH awarded CTT $1.44M on the second year of a competitive Small Business Innovation Research (SBIR) Phase IIB grant. The three year grant commenced in 2019 and totals $3.3M and this second year of funding supports the current CTT1403 clinical trial. The clinical trial, conducted at University of California, San Francisco with Dr. Rahul Aggarwal as Principal Investigator, is a 30-40 patient dose escalation/expansion trial in men with advanced castration-resistant prostate cancer. The trial is designed to show safety and efficacy of CTT1403 and is halfway through the initial dose escalation phase. To date there have been no safety issues with the drug and the pharmacokinetic data support the longer circulation time of CTT1403 in the blood stream as compared to other PSMA agents currently in clinical trials. "These PSMA-targeted agents are already transforming how prostate cancer is diagnosed and treated and we are very pleased that the NIH continues to support the development of these exciting new agents. CTT1403, with its longer circulating time and better tumor targeting characteristics, offers distinct advantages in this treatment arena providing the patient with cost and treatment benefits,” commented Dr. Beatrice Langton-Webster, CTT’s CEO and Principal Investigator on the grant. The unique chemical structure for CTT1403 was conceived of by Dr. Cliff Berkman, Professor at Washington State University (WSU). CTT1403 targets Prostate Specific Membrane Antigen (PSMA) which is over-expressed on prostate cancer. Two features make CTT1403 unlike other PSMA-targeted drugs currently in development: 1) Due to a unique core scaffold, CTT’s molecules bind irreversibly to PSMA and this distinctive mode of binding enables rapid uptake of the drug within the tumor; and 2) CTT1403 is engineered to increase the circulation time of the drug in the body which further substantially increases the dose of drug that accumulates at the tumor sites. CTT1403 is labeled with the radionuclide Lutetium-177 and once delivered to the tumor, the radionuclide acts to destroy the tumor cells. CTT completed two clinical trials at UCSF with CTT1057, the companion PET diagnostic imaging agent to CTT1403, with excellent safety and imaging results for both prostate cancer and renal cell carcinoma. CTT1057 is undergoing further development for prostate cancer by CTT’s licensing partner AAA/Novartis. CTT1057 and CTT1403 serve as a theranostic pair to both diagnose and treat solid tumors that express PSMA, and are being used together in the current clinical trial. More information on the trial can be found at clinicaltrials.gov. View source version on businesswire.com https://www.businesswire.com/news/home/20200807005027/en Contacts Cancer Targeted Technology Dr. Beatrice Langton-Webster bealw@cancertargetedtechnology.com

临床2期

2018-11-06

·cancertargetedtechnology

Cancer Targeted Technology Files Investigational New Drug Application for CTT1403, a Novel Radiotherapeutic Drug for Prostate Cancer

November 06, 2018 09:30 AM Eastern Standard Time SEATTLE--(BUSINESS WIRE)--Cancer Targeted Technology (CTT), a privately-held Seattle-based biotechnology company, announced today that it filed an Investigational New Drug Application (IND) with the FDA to move forward a radiotherapeutic drug, CTT1403, into human clinical trials for prostate cancer. CTT1403 is a peptidomimetic drug that targets Prostate Specific Membrane Antigen (PSMA). PSMA is over-expressed on prostate cancer and this expression increases as the cancer metastasizes and becomes hormone-resistant. Unlike other drugs, CTT’s molecules bind irreversibly to PSMA. This distinctive mode of binding enhances uptake and results in rapid and extensive internalization of these drugs by tumor cells, leading to increased uptake within the tumor. CTT1403 is labeled with the radionuclide 177-Lutetium and, unlike other PSMA-targeted drugs in clinical development, contains a unique albumin binding component. The albumin binding moiety on CTT1403 acts to increase the circulation of the drug in the body and further substantially increases the dose of drug that accumulates at the tumor sites. Once targeted to the tumor, the radionuclide on CTT1403 leads to tumor cell destruction. CTT1403 has shown excellent safety results to date in animal studies and CTT1403 treatment results in prolonged survival of animals with prostate cancer tumors. "We are very excited with the potential for CTT1403 to make a difference in men with advanced stage prostate cancer. This is a highly innovative molecule that combines excellent PSMA-targeting characteristics, already proven effective in prostate cancer, with the ability to enhance circulation time allowing for greater anti-tumor effects,” stated Dr. Beatrice Langton-Webster, CTT’s CEO and Principal Investigator for the clinical program. The unique chemical structure for CTT1403 was designed by Dr. Cliff Berkman, Professor of Chemistry at Washington State University (WSU) and consultant to CTT as its Chief Scientific Officer. The work to discover and progress CTT1403 through preclinical development to IND was funded by a $2.3M Small Business Innovation Research contract from the NIH. CTT recently completed clinical trials of CTT1057, the companion PET diagnostic to CTT1403, with excellent safety and imaging results. CTT1057 is undergoing further development and commercialization by CTT’s licensing partner AAA/Novartis. CTT1057 and CTT1403 can act as a theranostic pair to both diagnose and treat prostate cancer. Phase I clinical trials for CTT1403 are expected to start January, 2019. Contacts Cancer Targeted Technology Dr. Beatrice Langton-Webster bealw@cancertargetedtechnology.com

临床申请临床1期

100 项与 CTT-1403 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
转移性去势抵抗性前列腺癌	临床1期	美国	Cancer Targeted Technology LLC	2019-04-01
前列腺癌	临床1期	美国	Cancer Targeted Technology LLC	-

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03822871 (CTgov)	临床1期	转移性去势抵抗性前列腺癌	17	CTT1043 (0.75 GBq Cohort)	構獵齋鹹製遞憲淵窪繭 = 選淵範醖鹽觸壓顧夢襯鬱鑰壓蓋壓範壓艱淵選 (鹹繭範鏇顧壓築鹹襯襯, 範廠淵衊糧齋選壓窪鏇 ~ 鏇窪襯糧夢積積積齋製) 更多	-	2024-03-21
				CTT1043 (1.5 GBq Cohort)	構獵齋鹹製遞憲淵窪繭 = 襯鏇襯餘壓構襯膚壓鏇鬱鑰壓蓋壓範壓艱淵選 (鹹繭範鏇顧壓築鹹襯襯, 遞繭構築夢積蓋淵淵憲 ~ 鑰醖觸壓鹹獵繭窪願網) 更多
CTT1403 (SNMMI2020)	临床1期	PSMA阳性肿瘤 prostate specific membrane antigen	6	CTT1403 0.75 GBq	蓋鹹選簾選窪網糧鬱簾(顧顧廠衊糧遞築齋廠顧) = 網鹹積鑰膚顧壓鑰窪積衊淵簾淵鬱醖襯鑰構衊 (糧淵繭淵觸範繭鬱獵鏇, 0.36) 更多	积极	2020-05-15
				CTT1403 1.5 GBq	蓋鹹選簾選窪網糧鬱簾(顧顧廠衊糧遞築齋廠顧) = 糧鹹積夢構襯鬱願廠齋衊淵簾淵鬱醖襯鑰構衊 (糧淵繭淵觸範繭鬱獵鏇, 0.36) 更多