Multicenter, Randomized, Parallel Group, Phase 2 to Establish the Efficacy and Safety of Combinations of CBP501, Cisplatin, and Nivolumab for ≥3rd Line Treatment of Patients With Exocrine Pancreatic Cancer and WBC <10,000/mm3 at Screening

Multicenter, randomized, open-label, parallel group phase 2 study to assess the efficacy and tolerance of four combinations of CBP501, cisplatin, and nivolumab administered once every 21 days to patients with stage IV exocrine pancreatic cancer and WBC < 10,000/mm3 at screening.

开始日期2021-12-18

申办/合作机构

CanBas Co., Ltd.

NCT03113188

/ Completed临床1期

Phase 1b Clinical Study of CBP501, Cisplatin and Nivolumab Administered Every 3 Weeks in Patients With Advanced Refractory Tumors

This is a multicenter, open-label, phase 1b study of CBP501/cisplatin/nivolumab combination administered once every 21 days to patients with advanced solid tumors.

开始日期2017-10-25

申办/合作机构

CanBas Co., Ltd.

NCT00942825

/ Completed临床2期

Phase II Study of a Triplet Combination of CBP501, Pemetrexed and Cisplatin as First Line Treatment in Patients With Stage IV Non-squamous Non Small Cell Lung Cancer (NSCLC)

This is a randomized, open-label, multicenter, phase II study to compare a triplet combination of CBP501, pemetrexed and cisplatin with pemetrexed/cisplatin when administered to patients with locally advanced (stage IIIB with malignant pleural effusion or pericardial effusion) or metastatic (stage IV) non-squamous NSCLC as consecutive i.v. infusions according to a once-every-3-weeks schedule.
The protocol will evaluate full-dose cisplatin and pemetrexed with or without CBP501. Patients will be randomized in a 1:1 ratio to pemetrexed, cisplatin and CBP501 (Arm A) or pemetrexed and cisplatin (Arm B). Randomization will be stratified according to whether or not patients are eligible for bevacizumab therapy.
Preclinical and clinical findings that support this protocol are:
CBP501 has exhibited interesting preclinical activity in various lung cancer cell lines.
Synergism was documented with CBP501/cisplatin in the preclinical studies with lung cancer cell lines.
The dose-limiting toxicity (DLT) of CBP501 was rapid onset allergic reaction, as was suggested by preclinical toxicology. Other toxicities were quite limited. No evidence of potentiation of either CBP501 or cisplatin toxicity was found in the combination phase I trial, and the toxicity of the combination, primarily related to cisplatin, is manageable. It is expected that CBP501 and pemetrexed will display non-overlapping toxicity profiles in combination, given that hematological toxicity and gastrointestinal toxicity are the principal toxicity types of the latter.
Given the acceptable safety of the cisplatin/ pemetrexed combination, it is anticipated that the addition of CBP501 to this combination can be evaluated without excessive risk in the phase II programs.
The phase I study of CBP501 in combination with pemetrexed/cisplatin (phase I part of the mesothelioma program) did not show DLTs or evidence of enhancement of toxicities with the triplet combination. The RD of CBP501 25 mg/m², cisplatin 75 mg/m² and pemetrexed 500 mg/m² is currently in use in the phase II study with first line mesothelioma patients.
Hints of activity were observed during the phase I study with CBP501 and cisplatin.
No pharmacokinetics (PK) interaction was documented between cisplatin and CBP501.

开始日期2009-04-01

申办/合作机构

CanBas Co., Ltd.

100 项与 CBP-501 相关的临床结果

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100 项与 CBP-501 相关的转化医学

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100 项与 CBP-501 相关的专利（医药）

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项与 CBP-501 相关的文献（医药）

2024-04-01·European journal of cancer (Oxford, England : 1990)

A multicenter, randomized phase 2 study to establish combinations of CBP501, cisplatin and nivolumab for ≥3rd-line treatment of patients with advanced pancreatic adenocarcinoma

Article

作者: Siegel, R ; Orr, D ; Cline, V J ; Enzler, T ; Kawabe, T ; Paulson, S ; Nguyen, A ; Zalupski, M ; Richards, D ; Misleh, J ; Pierce, E ; Larson, T ; Ruste, S A ; Johns, M ; Shumway, N ; Chaves, J ; Haun, A ; Sahai, V ; Messersmith, W

BACKGROUND:

There is no standard of care for ≥ 3rd-line treatment of metastatic pancreatic adenocarcinoma (PDAC). CBP501 is a novel calmodulin-binding peptide that has been shown to enhance the influx of platinum agents into tumor cells and tumor immunogenicity. This study aimed to (1) confirm efficacy of CBP501/cisplatin/nivolumab for metastatic PDAC observed in a previous phase 1 study, (2) identify combinations that yield 35% 3-month progression-free survival rate (3MPFS) and (3) define the contribution of CBP501 to the effects of combination therapy.

METHODS:

CBP501 16 or 25 mg/m² (CBP(16) or CBP(25)) was combined with 60 mg/m² cisplatin (CDDP) and 240 mg nivolumab (nivo), administered at 3-week intervals. Patients were randomized 1:1:1:1 to (1) CBP(25)/CDDP/nivo, (2) CBP(16)/CDDP/nivo, (3) CBP(25)/CDDP and (4) CDDP/nivo, with randomization stratified by ECOG PS and liver metastases. A Fleming two-stage design was used, yielding a one-sided type I error rate of 2.5% and 80% power when the true 3MPFS is 35%.

RESULTS:

Among 36 patients, 3MPFS was 44.4% in arms 1 and 2, 11.1% in arm 3% and 33.3% in arm 4. Two patients achieved a partial response in arm 1 (ORR 22.2%; none in other arms). Median PFS and OS were 2.4, 2.1, 1.5 and 1.5 months and 6.3, 5.3, 3.7 and 4.9 months, respectively. Overall, all treatment combinations were well tolerated. Most treatment-related adverse events were grade 1-2.

CONCLUSIONS:

The combination CBP(25)/(16)/CDDP/nivo demonstrated promising signs of efficacy and a manageable safety profile for the treatment of advanced PDAC.

CLINICAL TRIAL REGISTRATION:

NCT04953962.

2023-05-01·Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

Immunogenic cell death inducer peptides: A new approach for cancer therapy, current status and future perspectives

Review

作者: Aria, Hamid ; Rezaei, Marzieh

Immunogenic Cell Death (ICD) is a type of cell death that kills tumor cells by stimulating the adaptive immune response against other tumor cells. ICD depends on the endoplasmic reticulum (ER) stress and the secretion of Damage-Associated Molecular Patterns (DAMP) by the dying tumor cell. DAMPs recruit innate immune cells such as Dendritic Cells (DC), triggering a cancer-specific immune response such as cytotoxic T lymphocytes (CTLs) to eliminate remaining cancer cells. ICD is accompanied by several hallmarks in dying cells, such as surface translocation of ER chaperones, calreticulin (CALR), and extracellular secretion of DAMPs such as high mobility group protein B1 (HMGB1) and adenosine triphosphate (ATP). Therapeutic peptides can kill bacteria and tumor cells thus affecting the immune system. They have high specificity and affinity for their targets, small size, appropriate cell membrane penetration, short half-life, and simple production processes. Peptides are interesting agents for immunomodulation since they may overcome the limitations of other therapeutics. Thus, the development of peptides affecting the TME and active antitumoral immunity has been actively pursued. On the other hand, several peptides have been recently identified to trigger ICD and anti-cancer responses. In the present review, we review previous studies on peptide-induced ICD, their mechanism, their targets, and markers. They include anti-microbial peptides (AMPs), cationic or mitochondrial targeting, checkpoint inhibitors, antiapoptotic inhibitors, and "don't eat me" inhibitor peptides. Also, peptides will be investigated potentially inducing ICD that is divided into ER stressors, ATPase inhibitors, and anti-microbial peptides.

2017-10-03·Oncotarget

CBP501 induces immunogenic tumor cell death and CD8 T cell infiltration into tumors in combination with platinum, and increases the efficacy of immune checkpoint inhibitors against tumors in mice

Article

作者: Kufe, Donald W. ; Sato, Takuji ; VonHoff, Daniel D. ; Sakakibara, Keiichi ; Kawabe, Takumi

CBP501, a calmodulin-binding peptide, is an anti-cancer drug candidate and functions as an enhancer of platinum uptake into cancer cells. Here we show that CBP501 promotes immunogenic cell death (ICD) in combination with platinum agents. CBP501 enhanced a clinically relevant low dose of cisplatin (CDDP) in vitro as evidenced by upregulation of ICD markers, including cell surface calreticulin exposure and release of high-mobility group protein box-1. Synergistic induction of ICD by CDDP plus CBP501 as compared to CDDP alone was confirmed in the well-established vaccination assay. Furthermore, cotreatment of CDDP plus CBP501 significantly reduced the tumor growth and upregulated the percentage of tumor infiltrating CD8⁺ T cell in vivo. Importantly, the antitumor effect of CDDP plus CBP501 was significantly reduced by anti-CD8 antibody treatment. Based on this novel effect of CBP501, we analyzed the combination treatment with immune checkpoint inhibitors in vivo. Mice treated with CBP501 in combination with CDDP and anti-PD-1 or anti-PD-L1 showed an additive antitumor effect. These results support the conclusion that CBP501 enhances CDDP-induced ICD in vitro and in vivo. The findings also support the further clinical development of the CBP501 for enhancing the antitumor activity of immune checkpoint inhibitors in combination with CDDP.

项与 CBP-501 相关的新闻（医药）

2025-01-16

·凯莱英药闻

信达生物：靶向CLDN 18.2 ADC纳入突破性治疗药物品种，用于治疗晚期胰腺导管腺癌

欢迎关注凯莱英药闻今日，信达生物宣布，公司IBI343再次被中国国家药品监督管理局（NMPA）药品评审中心（CDE）纳入突破性治疗药物（BTD）品种名单，拟定适应症为至少接受过一种系统性治疗的CLDN18.2表达阳性的晚期胰腺导管腺癌。 IBI343是一款抗紧密连接蛋白18.2（CLDN18.2）抗体-依喜替康偶联物（ADC），目前处于III期临床阶段。该药物最早曾于2024年5月被CDE纳入BTD品种名单，用于至少接受过二种系统性治疗的CLDN18.2表达阳性的晚期胃/胃食管交界处腺癌。关于IBI343 IBI343是一款重组人源靶向CLDN18.2的ADC，与表达CLDN18.2的肿瘤细胞结合后，可发生CLDN18.2依赖性ADC内化，并释放毒素药物引起DNA损伤，导致肿瘤细胞凋亡。游离的毒素药物也可以通过质膜扩散到达并杀死相邻的肿瘤细胞，因此IBI343也具有“旁观者效应”。该药物在多种不同表达量的肿瘤细胞系上，展现了良好的Claudin 18.2特异性的体外杀伤活性，并在多种人源肿瘤异种移植小鼠模型上展现了良好的肿瘤抑制活性。基于糖基的定点偶联技术显著增强了整个ADC的稳定性。IBI343在恒河猴的GLP毒理实验中展现了良好的安全性，并在高至30 mg/kg的剂量下耐受性良好。 2024年6月，IBI343获美国食品和药物监督管理局（FDA）授予快速通道资格（FTD），拟用于至少接受过一种系统性治疗的CLDN18.2表达阳性的晚期胰腺导管腺癌。本次突破性治疗药物认定是基于一项正在中国、澳洲和美国进行的I期临床研究结果，该I期扩展队列的数据在2024年欧洲肿瘤内科学会亚洲年会（ESMO Asia）大会上以口头形式报道。研究显示：该药物的整体疗效出色，患者mPFS 达到5.3 个月。在可评估的4 3 例患者中，ORR 为32.6%，cORR 为23.2%，cDCR 为81.4%，mDOR 为7.0（4.0-NC）个月，6个月DOR 率为63%，mPFS 为5.3（4.1- 7. 4）个月。公司此前已在2024 ASCO 首次报道的小样本数据，在10 名胰腺胆管腺癌患者中，未确认ORR 为40%。本次更新扩大样本数据与此前相当，且新增cORR 及PFS 数据。安全性上，三级以上胃肠道不良反应事件为0。在所有患者中，常见的不良反应为贫血、中性粒细胞计数减少、食欲下降、恶心和白细胞计数减少。51.2%的受试者发生≥3 级TEAE，其中≥3 级恶心、呕吐发生率均为0。关于靶向CLDN18.2的ADC CLDN18.2属于CLDNs家族成员，属于CLDNs18的亚型，它是一种CD20样分化的蛋白，尽管在正常组织中表达高度受限，在多种原发性恶性肿瘤发生发展过程中往往出现异常高表达。最初，其被发现能持续、稳定地高表达于多种胃癌组织，但随后研究表明，其也能在乳腺癌、结肠癌、肝癌、头颈癌、支气管癌以及非小细胞肺癌等多种原发恶性肿瘤中异常激活和过度表达，尤其好发于消化系统恶性肿瘤，包括胃癌（70%），胰腺癌（50％），食管癌（30％）等。预计2025-2035 年，美国和中国CLDN18.2抗体市场规模将分别从2.52 亿美元、2.00 亿美元增长至40.36 亿美元、37.44 亿美元，CAGR分别为32.0%、33.5%；其中，胃癌将贡献主要市场增量，2025-2035 年美国和中国CLDN18.2 抗体在胃癌领域市场规模将分别从0.65 亿美元、1.33 亿美元增长至10.87亿美元、24.03 亿美元，CAGR 分别为32.5%、33.6%。美国和中国CLDN18.2 抗体市场规模（亿美元）据不完全统计，目前在研的CLDN18.2约百余种，仅安斯泰来的佐妥昔单抗一款药物获批，研究种类主要包括ADC、CAR-T、双抗、单抗；由于CLDN18.2在特定肿瘤组织中具备高度选择性并稳定表达，同时在健康组织中表达受限，因此其逐渐作为开发癌症ADC 疗法的理想靶标。目前全球尚无已上市靶向CLDN18.2 ADC 药物, 除信达外，以国内企业礼新、康诺亚/乐普、恒瑞、德琪、荣昌、科伦博泰、信诺维等研发势头最强。关于胰腺癌胰腺癌是当前世界范围内死亡率最接近发病率的恶性肿瘤，恶性度高，进展快，转移早，预后差，因此被称为“癌症之王”。据GCO 统计，2022 年国内胰腺癌年新发约11.9 万人，死亡达10.6 万人。常见胰腺癌主要由于外分泌细胞形成，其中胰腺导管癌（PDAC）占比约80%。目前，晚期1L 治疗方案仍旧比较有限，多采用以氟尿嘧啶（5-FU）或吉西他滨为基础的化疗方案。二线治疗中，临床选择更加有限，无法为患者带来显著的临床获益，目前mPF S 普遍在2-3.5 个月左右， mOS 在6 个月左右。三线治疗中，目前报道的5-FU+LV+Na l-IRI 联合疗法及CBP501+cisplatin+n ivolu mab 疗法mPFS 均为1.9 个月。因此，胰腺癌2/ 3 线治疗存较大未满足临床需求。胰腺癌疗效整理对比关于信达生物信达生物成立于2011年，致力于开发、生产和销售肿瘤、代谢及心血管、自身免疫、眼科等重大疾病领域的创新药物。公司已有13款产品获得批准上市，同时还有4个品种在NMPA审评中，3个新药分子进入III期或关键性临床研究，另外还有17个新药品种已进入临床研究。近年来，公司与国内外众多知名企业和科研院，包括礼来、罗氏、赛诺菲、Adimab、Incyte和MD Anderson等国际合作方达成30多项战略合作。参考资料 1、公司官网 2、中信建投感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“hxsjjf1618”。 “在看”点一下

突破性疗法临床结果临床1期ASCO会议抗体药物偶联物

2023-11-14

·SYNAPSE

CBP-501: Brief Review of its R&D progress and the clinical outcome in 2023 ESMO

Metastatic pancreatic adenocarcinoma (PDAC) is an aggressive disease without third line standard-of-care treatment option. However, the latest research trial study of CBP-501 for the treatment of metastatic PDAC reported at the ESMO Congress exhibits promising therapeutic benefits. CBP-501's R&D ProgressCBP-501 is a synthetic peptide drug that targets CaM (Calmodulin). It is being developed by CanBas Co., Ltd., an originator organization in the pharmaceutical industry. CBP-501 has shown potential therapeutic applications in various therapeutic areas, including neoplasms, digestive system disorders, endocrinology and metabolic diseases, and respiratory diseases. Specifically, it has demonstrated efficacy in treating pancreatic cancer and metastatic non-squamous non-small cell lung carcinoma. According to the Patsnap Synapse, the drug is currently in Phase 2, which is the highest phase of clinical development globally. And the clinical trial distribution for CBP-501 are primarily in the United States. The key indication is Advanced Malignant Solid Neoplasm. Detailed Clinical Outcome of CBP-501The randomized, parallel assignment, open-labeled clinical trial (NCT04953962) was aimed to establish the efficacy and safety of CBP501, cisplatin, and nivolumab for ≥ third-line treatment of patients with exocrine pancreatic cancer and WBC <10,000/mm3. In this study, patients with metastatic PDAC, who failed two lines of systemic therapy, with white blood cell count <10,000/mm3 were stratified by ECOG (0 vs 1) and liver metastasis (present vs absent) and randomized 1:1:1:1 to arm 1 - CBP501 25 mg/m2 + cisplatin 60 mg/m2 + nivolumab 240 mg; arm 2 - CBP501 16 mg/m2 + cisplatin 60 mg/m2 + nivolumab 240 mg; arm 3 - CBP501 25 mg/m2 + cisplatin 60 mg/m2; or arm 4 - cisplatin 60 mg/m2 + nivolumab 240 mg. Patients received 4 cycles of combination therapy then 6 cycles of nivolumab every 21 days if without disease progression (nivolumab arms only). The primary endpoint was 3-month progression-free survival rate (3M PFSR) in the ITT population. Secondary endpoints were safety, PFS, objective response rate (ORR) and overall survival (OS). The result showed that as of October 17, 2022, efficacy was evaluable in 36 patients. 3M PFSR were 44%, 22%, 11% and 33% in arms 1, 2, 3 and 4, respectively. ORR were 22% in arm 1 (2 partial responses), 0% in arms 2, 3 and 4. Median PFS were 2.8, 2.1, 1.5 and 1.5 months, respectively. Median OS was not reached in arm 1 and 7.0, 2.7 and 3.8 months in arms 2, 3 and 4. Most common AEs were infusion-related reaction in 18/25 (72%; grade 1-2) during CBP501 infusion, and anemia in 2/33 (6%; both grade 3). SAEs occurred in 14/33 (42%); 13 SAEs were unrelated to CBP501. SAE acute renal failure (arm 3, after 1 cycle) was assessed as possibly related to CBP501 and definitely related to cisplatin. It can be concluded that preliminary results indicate clinically meaningful improvement and tolerable safety of CBP501, cisplatin and nivolumab as 3rd line treatment for metastatic PDAC. How to Easily View the Clinical Results Using Synapse Database?If you want to know the other clinical results of popular conferences, please lick on the “Clinical Results” on the homepage of Patsnap Synapse, which provides multi-dimensional screening and filtering of drugs, indications, targets, companies, result evaluation, release date, popular conferences, etc. to help you quickly locate the data you need. Select the clinical meeting you are interested in, such as ESMO. In the results, you can quickly locate the data you want to view by indication, phase and drug name. A single result clearly shows important information such as registration number, phase, indication, Sponsor/Collaborator, biomarker, Trial number, dosing regimen and more. If you would like to view more information about this result, you can go to the result detail page by clicking on the title. Above the headings, we provide the original source of the outcome data. The basic information is supplemented with more information beyond the list, such as company, study. design, etc. In the important Outcome Measures section, we provide both list and flowchart forms, which are convenient for you to overview the comparison group information and core indicator data. Finally, if you need to download these results, you can conveniently check the check boxes on the left side of the list, or directly click the "Export" button to download the data for personalized analysis and file sharing. Click on the image below to embark on a brand new journey of drug discovery!

2023-01-02

·PRNewswire

Propulsion of Pancreatic Cancer Pipeline as Novel and Extensive 170+ Therapies Likely to Enter in the Treatment Domain | DelveInsight

The prevalence of pancreatic cancer has been rising since the past few years, which prompts the growing demand for treatment options. The increasing prevalence of cancer, the robust pipeline, and the growing research and development activities to develop novel therapies to treat Pancreatic Cancer drive the market. The companies developing the potential therapies in the last stage of development include FibroGen, Eli Lilly and Company, CARsgen Therapeutics, and several others. LAS VEGAS, Jan. 2, 2023 /PRNewswire/ -- DelveInsight's ' Pancreatic Cancer Pipeline Insight – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline pancreatic cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the pancreatic cancer pipeline domain. Key Takeaways from the Pancreatic Cancer Pipeline Report DelveInsight's pancreatic cancer pipeline report depicts a robust space with 150+ active players working to develop 170+ pipeline therapies for pancreatic cancer treatment. Key pancreatic cancer companies such as FibroGen, Innovent Biologics, CARsgen Therapeutics, Ascentage Pharma, NGM Biopharmaceuticals, TME Pharma AG, Lee's Pharmaceutical Limited, ImmunityBio, Inc., Rgene Corporation, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., CanBas Co. Ltd., Jiangsu HengRui Medicine Co., Ltd., Bristol-Myers Squibb, SynerGene Therapeutics, Inc., AbbVie, Silenseed Ltd, Galera Therapeutics, Inc., Helix BioPharma, Golden Biotechnology Corporation, Eli Lilly and Company, Innovent Biologics (Suzhou) Co. Ltd., Panbela Therapeutics, Inc., GlaxoSmithKline, Chia Tai Tianqing Pharmaceutical Group, Roche, Prestige Biopharma Limited, Everfront Biotech Co., Ltd., XBiotech, Inc., Incyte Corporation, Ability Pharmaceuticals SL, Lokon Pharma, HCW Biologics, Amplia Therapeutics Limited, BioLineRx, Ltd., Taiho Pharmaceutical, Sanofi, Scandion Oncology, Nelum, Celldex Therapeutics, Merus N.V., Seagen Inc., GC Cell Corporation, MetiMedi Pharmaceuticals, Lumicell, Nuvation Bio Inc., ENB Therapeutics, BioNTech SE, Bayer, Genentech, Inc., Rise Biopharmaceuticals, Inc., Prestige Biopharma Limited, iOnctura, Shanghai Unicar-Therapy Bio-medicine Technology, Shanghai Hengrui Pharmaceutical Co., Ltd., Hangzhou Neoantigen Therapeutics Co., Ltd., EUSA Pharma, Inc.,Agenus Inc., Arcus Biosciences, Inc.Amgen, Biomea Fusion, and others are evaluating pancreatic cancer drugs to improve the treatment landscape. Promising pancreatic cancer pipeline therapies in various stages of development include Pamrevlumab, Niraparib, CT041, APG-1387, BNT141, ENB003, NUV-868, MCLA-128, LUM015, tisotumab vedotin, OMT-111, tusamitamab ravtansine, SCO-101, NGM120, CDX-301, NLM-001, TAS 102, Olaptesed pegol, BL-8040, Gimatecan, AMP945, N-803, HCW9218, BLEX 404, delolimogene mupadenorepvec, Mitoxantrone Hydrochloride Liposome injection, ABTL0812, CBP501, Pemigatinib, SHR-1701, Fluzoparib, XB2001, Cabiralizumab, EF-009, SGT-53, ABBV-927, PBP1510, Vemurafenib, siG12D-LODER, Penpulimab, GC4711, GSK2256098, L-DOS47, SBP-101, Antroquinonol, LY3214996, Sintilimab, RP72, PBP1510, IOA-289, U87, MVT-5873, SHR-A1904, iNeo-Vac-P01, iNeo-Vac-P01, TQB2858, Siltuximab, AGEN1423, AB680, AMG 199, BMF-219, and others. In December 2022, Targovax ASA announced that it has entered into a collaboration agreement with The University of Kansas Cancer Center (KU Cancer Center) and Agenus Inc. to run a clinical trial testing mutant RAS vaccine TG01 in combination with PD-1 CPI balstilimab in pancreatic cancer following surgery and standard-of-care (SoC) chemotherapy. In December 2022, Bluestar Genomics, Inc. announced the initiation of the New Onset Diabetes Management for Earlier Detection (NODMED) trial, one of the largest clinical studies in pancreatic cancer to date. The trial will use Bluestar Genomics' proprietary epigenomic methods for the detection of the disease. In December 2022, iOnctura BV, a clinical-stage biotech developing novel cancer therapies, had been granted €17.5 million ($18.6 million) funding from the European Investment Council's (EIC) accelerator program to develop IOA-289 for pancreatic cancer.The EIC's funding consists of a grant of €2.5 million ($2.7 million) and €15 million ($16 million) of equity investment. In December 2022, In the Phase I/II CodeBreaK 100 trial, the KRAS G12C inhibitor sotorasib achieved meaningful anticancer activity with an acceptable safety profile in heavily pretreated patients with KRAS G12C-mutated metastatic pancreatic cancer, according to researchers at The University of Texas MD Anderson Cancer Center. The results of the trial, published in the The New England Journal of Medicine, indicate an objective response rate of 21.1% and a median time-to-response of 1.5 months, with 84% of patients experiencing disease control. Median progression-free survival was 4 months, and overall survival was 6.9 months. In December 2022, Oncolytics Biotech® Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to pelareorep in combination with Roche's anti-PD-L1 checkpoint inhibitor atezolizumab, and the chemotherapeutic agents gemcitabine and nab-paclitaxel, for the treatment of advanced/metastatic pancreatic ductal adenocarcinoma (PDAC). This represents pelareorep's second FDA Fast Track designation. In December 2022, RemeGen Co., Ltd. announced that its latest antibody-drug conjugate (ADC), RC118 for injection, has been granted two orphan drug designations (ODD) by the United States Food and Drug Administration (FDA) for gastric cancer (including gastroesophageal junction cancer) and pancreatic cancer. This marks the Company's fourth, having previously been granted ODD twice for Disitamab Vedotin (RC48) and Telitacicept (RC18) earlier this year. In December 2022, Panbela Therapeutics, Inc. announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products issued a positive opinion on Panbela's application for orphan designation of ivospemin ( SBP-101) in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (PDA). In September 2022, Qualigen Therapeutics, Inc. announced the presentation of two posters on QN-302 at the AACR 8th Special Conference on Pancreatic Cancer. The data presented include information on the compound's safety, tolerability, and efficacy in a pancreatic cancer model. The poster included preclinical toxicology data that showed QN-302 does not produce adverse toxicological reactions in mouse models at therapeutic doses. In in vitro tests, QN-302 inhibits acetylcholinesterase (AChE) by 53% and muscarinic receptor (M2) by 70% at 1 µM. Request a sample and discover the recent advances in pancreatic cancer drugs @ Pancreatic Cancer Pipeline Report The pancreatic cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage pancreatic cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the pancreatic cancer clinical trial landscape. Pancreatic Cancer Overview Pancreatic cancer develops in the pancreas tissues, an abdomen organ located behind the stomach's bottom portion. The pancreas secretes hormones that help control blood sugar and enzymes that aid digestion. Pancreatic cancer is a condition in which malignant (cancer) cells develop in pancreatic tissues. The pancreas can develop tumors in various ways, including malignant and noncancerous tumors. However, the precise causes of pancreatic cancer are unknown. Individuals diagnosed with pancreatic cancer before the tumor develops or spreads have an average life expectancy of pancreatic cancer of 3 to 3.5 years. Pancreatic cancer symptoms may include jaundice, dark urine, weight loss, loss of appetite, fatigue, and others. A pancreatic cancer diagnosis is difficult because symptoms are frequently confused with those of other disorders, such as irritable bowel syndrome. The extent of the cancer determines the treatment of pancreatic cancer options. Pancreatic cancer treatment options may include surgery, chemotherapy, radiation therapy, targeted therapy, or a combination of these. Learn more about the diseases and pancreatic cancer diet @ Pancreatic Cancer Tests A snapshot of the Pancreatic Cancer Pipeline Drugs mentioned in the report: Learn more about the emerging pancreatic cancer treatment options @ Pancreatic Cancer Clinical Trials Pancreatic Cancer Therapeutics Assessment The pancreatic cancer pipeline report proffers an integral view of pancreatic cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Pancreatic Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Inhalation, Intranasal, Intravenous, Oral, Parenteral, Subcutaneous Therapeutics Assessment By Molecule Type: Antibody, Antisense oligonucleotides, Immunotherapy, Monoclonal antibody, Peptides, Protein, Recombinant protein, Small molecule, Stem Cell, Vaccine Therapeutics Assessment By Mechanism of Action: Connective tissue growth factor inhibitors, Poly(ADP-ribose) polymerase 1 inhibitors, Poly(ADP-ribose) polymerase 2 inhibitors, Immunologic cytotoxicity, T lymphocyte replacements, Growth differentiation factor 15 inhibitors, Endothelin B receptor antagonists, Image enhancers Key Pancreatic Cancer Companies: FibroGen, Innovent Biologics, CARsgen Therapeutics, Ascentage Pharma, NGM Biopharmaceuticals, TME Pharma AG, Lee's Pharmaceutical Limited, ImmunityBio, Inc., Rgene Corporation, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., CanBas Co. Ltd., Jiangsu HengRui Medicine Co., Ltd., Bristol-Myers Squibb, SynerGene Therapeutics, Inc., AbbVie, Silenseed Ltd, Galera Therapeutics, Inc., Helix BioPharma, Golden Biotechnology Corporation, Eli Lilly and Company, Innovent Biologics (Suzhou) Co. Ltd., Panbela Therapeutics, Inc., GlaxoSmithKline, Chia Tai Tianqing Pharmaceutical Group, Roche, Prestige Biopharma Limited, Everfront Biotech Co., Ltd., XBiotech, Inc., Incyte Corporation, Ability Pharmaceuticals SL, Lokon Pharma, HCW Biologics, Amplia Therapeutics Limited, BioLineRx, Ltd., Taiho Pharmaceutical, Sanofi, Scandion Oncology, Nelum, Celldex Therapeutics, Merus N.V., Seagen Inc., GC Cell Corporation, MetiMedi Pharmaceuticals, Lumicell, Nuvation Bio Inc., ENB Therapeutics, BioNTech SE, Bayer, Genentech, Inc., Rise Biopharmaceuticals, Inc., Prestige Biopharma Limited, iOnctura, Shanghai Unicar-Therapy Bio-medicine Technology, Shanghai Hengrui Pharmaceutical Co., Ltd., Hangzhou Neoantigen Therapeutics Co., Ltd., EUSA Pharma, Inc.,Agenus Inc., Arcus Biosciences, Inc., Amgen, Biomea Fusion, and others. Key Pancreatic Cancer Pipeline Therapies: Pamrevlumab, Niraparib, CT041, APG-1387, BNT141, ENB003, NUV-868, MCLA-128, LUM015, tisotumab vedotin, OMT-111, tusamitamab ravtansine, SCO-101, NGM120, CDX-301, NLM-001, TAS 102, Olaptesed pegol, BL-8040, Gimatecan, AMP945, N-803, HCW9218, BLEX 404, delolimogene mupadenorepvec, Mitoxantrone Hydrochloride Liposome injection, ABTL0812, CBP501, Pemigatinib, SHR-1701, Fluzoparib, XB2001, Cabiralizumab, EF-009, SGT-53, ABBV-927, PBP1510, Vemurafenib, siG12D-LODER, Penpulimab, GC4711, GSK2256098, L-DOS47, SBP-101, Antroquinonol, LY3214996, Sintilimab, RP72,PBP1510, IOA-289, U87, MVT-5873, SHR-A1904, iNeo-Vac-P01, iNeo-Vac-P01, TQB2858, Siltuximab, AGEN1423, AB680, AMG 199, BMF-219, and others. Dive deep into rich insights for pancreatic cancer research; visit @ New Treatment for Pancreatic Cancer Table of Contents For further information on pancreatic cancer prevention, reach out @ Pancreatic Cancer Drug Treatment Related Reports Pancreatic Cancer Epidemiology Pancreatic Cancer Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted pancreatic cancer epidemiology in the 7MM. Pancreatic Cancer Market Pancreatic Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key pancreatic cancer companies, including FibroGen, NeoImmuneTech, NOXXON Pharma, Silenseed Ltd., Amgen, NGM Biopharmaceuticals, among others. Advanced Pancreatic Cancer Market Advanced Pancreatic Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key advanced pancreatic cancer companies, including AstraZeneca, Merck Sharp & Dohme LLC, Bayer, Roche, among others. Advanced Pancreatic Cancer Pipeline Advanced Pancreatic Cancer Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key advanced pancreatic cancer companies, including FibroGen, NeoImmuneTech, NOXXON Pharma, Silenseed Ltd., Amgen, NGM Biopharmaceuticals, among others. Metastatic Pancreatic Cancer Market Metastatic Pancreatic Cancer Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key metastatic pancreatic cancer companies, including Takeda Oncology, Salspera, Eli Lilly and Company, among others. Metastatic Pancreatic Cancer Pipeline Metastatic Pancreatic Cancer Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key metastatic pancreatic cancer companies, including Takeda Oncology, Salspera, Eli Lilly and Company, among others. Other Trending Oncology Reports Follicular lymphoma | Indolent lymphoma | Severe Toxicities In Lymphoma | Marginal Zone Lymphoma | Vulvar Squamous Cell Carcinoma | Cholangiocarcinoma | Metastatic Cutaneous Squamous cell Carcinoma | Nasopharyngeal Carcinoma | Ductal Carcinoma in Situ | Oncolytic Virus Cancer Therapy | Cancer Cachexia | Intratumoral Cancer Therapies | Brain Cancer Related Healthcare Blogs Upcoming Oncology Drugs Oncology Market Outlook Future of Oncology Market Related Cases Studies Competitive Intelligence Market Assessment Product Assessment Epidemiology Assessment Related Healthcare Services Healthcare Business Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

快速通道孤儿药临床结果免疫疗法

100 项与 CBP-501 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
胰腺癌	临床2期	美国	CanBas Co., Ltd.	2021-12-18
转移性非鳞状非小细胞肺癌	临床2期	美国	CanBas Co., Ltd.	2009-04-01
晚期恶性实体瘤	临床2期	美国	CanBas Co., Ltd.	2008-05-01
不可切除的胸膜恶性间皮瘤	临床2期	美国	CanBas Co., Ltd.	2008-05-01
子宫内膜癌	临床1期	美国	CanBas Co., Ltd.	2006-11-01
卵巢癌	临床1期	美国	CanBas Co., Ltd.	2006-11-01

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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


NCT04953962 (Pubmed) 人工标引	临床2期	胰腺癌三线	36	CBP501 25 mg/m2/CiCisplatinivoNivolumab	鏇齋夢憲齋鏇壓鹹廠蓋(夢構餘壓獵構鹽蓋願鬱) = 鹽構膚築遞鏇觸廠繭築製廠繭齋範製遞鹽糧廠 (衊願膚顧範鹽選夢願淵 ) 更多	积极	2024-04-01
				CBP501 16 mg/m2/CiCisplatinivoNivolumab	鏇齋夢憲齋鏇壓鹹廠蓋(夢構餘壓獵構鹽蓋願鬱) = 範獵製鏇選網夢鹽範憲製廠繭齋範製遞鹽糧廠 (衊願膚顧範鹽選夢願淵 ) 更多
NCT04953962 (ESMO 12023 \| ESMO 22023) 人工标引	临床2期	胰腺癌三线	36	CBP501 25 mg/m2 + cisplatin 60 mg/m2 + nivolumab 240 mg	膚遞鬱積構憲築願繭簾(選構製築膚齋醖窪淵遞) = 顧構鹹蓋獵願壓夢網齋襯製繭鏇選構製積鹽醖 (網繭鹹鹽範獵選簾範構 ) 更多	积极	2023-10-23
				CBP501 16 mg/m2 + cisplatin 60 mg/m2 + nivolumab 240 mg	膚遞鬱積構憲築願繭簾(選構製築膚齋醖窪淵遞) = 鬱鹽窪鬱憲醖餘艱簾築襯製繭鏇選構製積鹽醖 (網繭鹹鹽範獵選簾範構 ) 更多
NCT00700336 (CTgov)	临床1/2期	不可切除的胸膜恶性间皮瘤 \| 恶性胸膜间皮瘤 \| 晚期恶性实体瘤	69	cisplatin+CBP501+pemetrexed (Pemetrexed, Cisplatin, and CBP501: Phase 2)	築簾餘蓋範鹽鹽獵範齋(網鹹製鏇壓窪餘構夢夢) = 糧範構顧廠窪觸遞淵憲齋積齋餘膚繭網夢鑰觸 (獵鏇範構鹽獵餘齋鹽糧, 衊餘網簾糧襯鑰鑰遞衊 ~ 鏇廠醖淵艱積範網壓遞) 更多	-	2021-07-20
				cisplatin+pemetrexed (Pemetrexed and Cisplatin: Phase 2)	築簾餘蓋範鹽鹽獵範齋(網鹹製鏇壓窪餘構夢夢) = 夢糧憲鑰窪積淵夢觸齋齋積齋餘膚繭網夢鑰觸 (獵鏇範構鹽獵餘齋鹽糧, 糧鏇醖夢積獵網鹽網鏇 ~ 窪願壓範淵襯顧衊繭窪) 更多
NCT03113188 (ASCO 12020 \| ASCO 22020) 人工标引	临床1期	实体瘤	25	cisplatin+nivolumab+CBP501	鹽蓋製餘鬱鑰積醖範膚(鑰簾鑰範顧壓繭選積構) = 餘廠衊鏇願艱廠遞願網鹽夢築範構鑰壓齋醖鑰 (築鹹壓顧艱糧窪選積鏇 ) 更多	积极	2020-05-29
				cisplatin+nivolumab+CBP501	窪鬱積範積範鹽構構遞(窪鏇壓鬱獵餘夢網窪艱) = 鹽鏇鏇糧遞獵鑰構襯壓艱築艱鹹餘構遞積獵範 (範膚構廠製廠獵鹽選觸 ) 更多
NCT00942825 (CBP08-02, CTgov)	临床2期	转移性非鳞状非小细胞肺癌	195	Cisplatin+CBP501+Pemetrexed (A CBP501 +Cisplatin + Pemetrexed)	製憲構醖夢膚淵衊襯築(餘壓廠鏇選鏇獵衊遞觸) = 顧簾夢鑰夢襯憲繭鑰觸餘獵齋襯選廠鏇觸鏇顧 (積夢顧觸廠淵鏇顧鏇鹹, 範廠齋構繭積構繭糧鬱 ~ 糧夢廠衊膚淵願構鬱範) 更多	-	2017-05-24
				Cisplatin+Pemetrexed (B Cisplatin + Pemetrexed)	製憲構醖夢膚淵衊襯築(餘壓廠鏇選鏇獵衊遞觸) = 獵廠糧範窪廠築壓醖製餘獵齋襯選廠鏇觸鏇顧 (積夢顧觸廠淵鏇顧鏇鹹, 築糧鏇構選蓋觸艱願選 ~ 顧積膚範繭簾艱膚壓繭) 更多
ASCO2012	临床2期	恶性胸膜间皮瘤	65	pemetrexed/cisplatin plus CBP501 25 mg/m2 IV	夢鹽憲製選衊壓築鹽廠(鬱網積鏇觸顧醖窪觸鏇) = The most common toxicity of CBP501 is infusion-related urticaria, which is easily managed with diphenhydramine 窪觸鏇積餘繭鏇顧積鏇 (鬱齋遞獵築顧顧鑰齋網 )	-	2012-05-20
				pemetrexed/cisplatin alone
ASCO2008	临床1期	晚期恶性实体瘤	-	CBP501	顧壓獵淵鬱憲網淵艱淵(獵構齋壓壓衊夢觸鏇襯) = 淵觸鏇蓋夢構淵獵鬱餘廠壓憲構壓廠鹽築餘獵 (糧鹹襯膚壓顧選鹹積選 )	-	2008-05-20