Background:
There are no approved drugs to treat recurrent thymoma and thymic carcinoma. New therapies are needed for people with these cancers. Researchers want to see if the drug PT-112 can help. PT-112 kills cancer cells. It also helps the body s immune system fight cancer.
Objective:
To see if the study drug PT-112 can cause tumors to shrink.
Eligibility:
People ages 18 and older who have thymoma or thymic cancer and whose disease returned or progressed after treatment with at least one platinum-containing chemotherapy, or who have refused standard treatment.
Design:
Participants will be screened with:
Review of medical history and medications
Physical exam
Blood and urine tests
CT or MRI scans of parts of the body, including the brain
Participants will get PT-112 in 28-day cycles, on days 1 and 15 of of the first cycle and on day 1 of each cycle after that. They will get the drug by infusion through a catheter. The catheter is a small plastic tube put into a vein. On days they receive the drug, participants will have physical exams and blood and urine tests. They will have an ECG to test heart function on day 1 of each cycle.
Participants will have scans every 8 weeks.
Participants may choose to have tumor biopsies on day 1 of cycles 1 and 3. Biopsies may be guided by an ultrasound or CT scan.
Participants will continue treatment as long as they can handle the side effects and their disease does not get worse, for up to 8 years.
Participants will have follow-up visits 2 weeks and 4 weeks after they stop therapy. Then the study team will check on participants every 3 months until 8 years after the participant joined the study.

开始日期2022-04-06

申办/合作机构

National Cancer Institute

NCT05357196

/ Unknown status临床1/2期

An Open-label Phase I/II Clinical Trial of PT-112 Combine With Gemcitabine Injection for Advanced Solid Tumors

Phase I dose escalation period: solid tumors, including but not limited to biliary tract cancer, pancreatic cancer, ovarian cancer, thymoma, neuroendocrine carcinoma and other advanced solid tumors.
Phase II trial period: biliary tract cancer

开始日期2020-04-13

申办/合作机构

SciClone Pharmaceuticals LLC

CTR20190817

/ Recruiting临床1/2期

一项PT-112联合吉西他滨注射液治疗晚期实体瘤患者的开放性I/II期临床研究

评估PT-112注射液联合吉西他滨注射液治疗晚期实体瘤患者的安全性和耐受性。估PT-112注射液联合吉西他滨注射液以II期推荐剂量治疗晚期胆道癌患者的抗肿瘤作用。

开始日期2020-04-13

申办/合作机构

赛生医药研发（上海）有限公司

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100 项与 PT-112 相关的临床结果

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100 项与 PT-112 相关的转化医学

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100 项与 PT-112 相关的专利（医药）

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项与 PT-112 相关的文献（医药）

2022-07-01·eClinicalMedicine

Phase I study of PT-112, a novel pyrophosphate-platinum immunogenic cell death inducer, in advanced solid tumours

Article

作者: Camidge, D Ross ; Jimeno, José ; Price, Matthew R ; Infante, Jeffery R ; Karp, Daniel D ; Bryce, Alan H ; Ames, Tyler D

BackgroundPT-112, the first pyrophosphate-platinum conjugate, causes immunogenic cell death in experimental models, leading to recruitment of tumour-infiltrating lymphocytes. PT-112 also associates with bone (osteotropism), likely driven by its pyrophosphate moiety. This is the first-in-human study of PT-112 monotherapy, exploring its safety and efficacy in a patient population where standard of care therapies were exhausted and novel treatment options are needed.MethodsPatients with progressing, advanced solid tumours received PT-112 intravenously (1 h) on days 1, 8, 15 of a 28-day cycle in an open-label, multi-centre 3 + 3 dose-escalation trial, conducted at four US research sites. The primary objective was to assess safety and pharmacokinetics, and to identify a recommended phase 2 dose (RP2D). Eligibility criteria included: age ≥18 years, Eastern Collaborative Oncology Group (ECOG) Performance Status of 0-1, and disease evaluable by Response Evaluation Criteria in Solid Tumours (RECIST) v1·1 or by informative tumour markers. Patients receiving ≥1 dose of PT-112 were included in the safety and pharmacokinetic analyses, with the exploratory efficacy analysis including patients receiving ≥1 dose at 125 mg/m². This study is registered at ClinicalTrials.gov, number NCT02266745, with the dose-escalation portion of the study closed.FindingsBetween July 7th, 2014 and September 18th, 2018, 66 heavily pre-treated patients (median 4 prior lines, IQR 2-6) were enrolled and treated across 11 doses (12-420 mg/m²). Treatment-related adverse events included fatigue (23 patients, 35%), nausea (16 patients, 24%), and peripheral neuropathy (14 patients, 21%). Grade 3 events were experienced by 18 patients (27%), with no grade 4-5 events observed. The recommended phase 2 dose was determined to be 360 mg/m². Nine (17%) of the 54 efficacy evaluable patients achieved progression-free survival ≥6 months. Durable partial responses were induced in non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and thymoma. Radiographic and serum marker reductions were observed among ten patients with metastatic castration resistant prostate cancer, four of whom survived two years or longer.InterpretationPT-112 is safe and well-tolerated in a heavily pre-treated population. Prolonged responses were noted against thymoma and lung cancer, along with radiographic and serum marker improvement in prostate cancer. Given the heterogeneous patient population, subsequent studies will be needed to characterize the risk/benefit ratio in more homogenous settings. Further development of PT-112 is ongoing, as single-agent and in combination with immune checkpoint inhibition.FundingFunding was provided by Promontory Therapeutics Inc.

2020-01-01·OncoImmunology2区 · 医学

PT-112 induces immunogenic cell death and synergizes with immune checkpoint blockers in mouse tumor models

2区 · 医学

ArticleOA

作者: Yamazaki, Takahiro ; Galluzzi, Lorenzo ; Ames, Tyler D. ; Buqué, Aitziber

PT-112 is a novel platinum-pyrophosphate conjugate under clinical development for cancer therapy. PT-112 mediates cytostatic and cytotoxic effects against a variety of human and mouse cancer cell lines in vitro. The cytotoxic response to PT-112 is associated with the emission of danger signals underpinning the initiation of anticancer immunity, including calreticulin exposure on the surface of dying cells, as well as ATP and HMGB1 secretion. Consistently, mouse cancer cells succumbing to PT-112 in vitro can be used to provide syngeneic, immunocompetent mice with immunological protection against a subsequent challenge with living tumor cells of the same type. Moreover, PT-112 administration synergizes with PD-1 or PD-L1 blockade in the control of mouse cancers in immunologically competent settings, as it simultaneously recruits immune effector cells and depletes immunosuppressive cells in the tumor microenvironment. Finally, PT-112 employed intratumorally in the context of immune checkpoint inhibition initiates a robust immune response that has systemic outreach and limits the growth of untreated, distant lesions. Thus, PT-112 induces the immunogenic demise of cancer cells, and hence stands out as a promising combinatorial partner of immune checkpoint blockers, especially for the treatment of otherwise immunologically cold tumors.

2018-01-01·European Journal of Medicinal Chemistry1区 · 医学

Photoactive platinum(II) complexes of nonsteroidal anti-inflammatory drug naproxen: Interaction with biological targets, antioxidant activity and cytotoxicity

1区 · 医学

Article

作者: Verma, Madhu ; Srivastava, Payal ; Patra, Ashis K ; Singh, Khushbu ; Sivakumar, Sri

The effect on the therapeutic efficacy of Pt(II) complexes on combining non-steroidal anti-inflammatory drugs (NSAIDs) is an attractive strategy to circumvent chronic inflammation mediated by cancer and metastasis. Two square-planar platinum(II) complexes: [Pt(dach)(nap)Cl] (1) and [Pt(dach)(nap)₂] (2), where dach = (1R,2R)-dichloro(cyclohexane-1,2-diamine) and NSAID drug naproxen (nap), have been designed for studying their biological activity. The naproxen bound to the Pt(II) centre get released upon photoirradiation with low-power UV-A light as confirmed by the significant enhancement in emission intensities of the complexes. The compounds were evaluated for their photophysical properties, photostability, reactivity with 5'-guanosine monophophosphate (5'-GMP), interactions with CT-DNA and BSA, antioxidant activity and reactive oxygen species mediated photo-induced DNA damage properties. ESI-MS studies demonstrated the formation of bis-adduct with 5'-GMP and the formation of Pt^II-DNA crosslinks by gel electrophoretic mobility shift assay and ITC studies. The interaction of the complexes 1 and 2 with the CT-DNA exhibits potential binding affinity (K_b ∼ 10⁴ M^-1, K_app∼ 10⁵ M^-1), implying intercalation to CT-DNA through planar naphthyl ring of the complexes. Both the complexes also exhibit strong binding affinity towards BSA (K_BSA∼ 10⁵ M^-1). The complexes exhibit efficient DNA damage activity on irradiation at 365 nm via formation of singlet oxygen (¹O₂) and hydroxyl radical (^•OH) under physiological conditions. Both the complexes were cytotoxic in dark and exhibit significant enhancement of cytotoxicity upon photo-exposure against HeLa and HepG2 cancer cells giving IC₅₀ values ranging from 8 to 12 μM for 1 and 2. The cellular internalization data showed cytosolic and nuclear localization of the complexes in the HeLa cells.

项与 PT-112 相关的新闻（医药）

2024-11-04

·新药前沿

抗癌小分子免疫疗法终于到来了

抗癌小分子免疫疗法终于到来了机制探索核糖体是细胞内蛋白质合成重要的细胞器，影响细胞的正常功能。核糖体在核仁中通过核糖体生物合成(RiBi)过程制造，是细胞生长和分裂所需蛋白质合成的关键。癌细胞需要更高水平的核糖体活性才能存活并促进恶性肿瘤。几乎所有类型的癌症都表现出大量和/或增加的核仁数量，从而促进癌细胞对RiBi抑制的敏感性更高。因此，与健康细胞相比，癌细胞更容易受到RiBi抑制的影响。 RiBi抑制会导致癌细胞应激，并导致死亡癌细胞释放受损相关分子模式（DAMP）。这些DAMP是免疫原性细胞死亡(ICD)的标志，包括钙网蛋白转位、ATP分泌以及HMGB1和免疫刺激细胞因子（如I型干扰素）的释放。 ICD是一种独特的癌细胞死亡形式，可激活免疫反应。相比之下，细胞凋亡通常是耐受性的，不会导致免疫反应。 DAMP与树突状细胞上的特定模式识别受体(PRR)结合，导致肿瘤特异性抗原的呈递和效应T细胞的激活。从而启动适应性免疫反应，并将活化淋巴细胞浸润到肿瘤微环境(TME)。新药开发 Promontory Therapeutics公司开发的PT-112单独治疗或与已上市的检查点抑制剂联合使用可增加TME中的细胞毒性T细胞(CTL)。这意味着免疫细胞群向抗癌环境发生有利转变。 PT-112通过抑制核仁中的RiBi会导致细胞器应激（ER和线粒体），从而释放特定的DAMP。除了适应性免疫反应外，PT-112还通过NK细胞的参与激活先天免疫反应。这种免疫激活的级联反应会产生强大且可能持久的免疫反应。根据临床前模型，PT-112代表了潜在的同类最佳（First in Class）ICD诱导剂。 PT-112是肿瘤领域首个进入临床开发阶段中焦磷酸偶联物。PT-112具有众多优势，包括耐受性、向骨性和抑制RiBi，从而导致ICD。顺铂（CDDP）、卡铂和奥沙利铂等铂类化疗药物虽然已广泛用于临床治疗多种肿瘤，如肺癌、卵巢癌和结直肠癌。然而，铂类衍生物具有相当大的毒性，且获得性耐药发生率较高。 R,R-1,2环己二胺-焦磷酸-铂(II)(PT-112)就是在这样的背景下开发出来的，其具体目的是改变药物的细胞作用机制，以提高其疗效，同时限制其毒性。从化学角度来看，PT-112与其他铂衍生物不同，因为Pt2+离子被二氨基环己烷和焦磷酸盐部分螯合。焦磷酸盐以双阴离子状态存在于血浆中，使PT-112具有更好的药代动力学和药效学特性，包括在肺、肝和骨骼中（小鼠中）有相当大的蓄积趋势。在剂量递增I期临床试验中，多名这些器官中存在原发性或转移性病变的患者，在接受几种常规和/或试验性治疗均失败后，在全身给药PT-112后出现了强劲而持久的反应。 PT-112正在进行治疗转移性去势抵抗性前列腺癌(mCRPC)、胸腺瘤的2期试验，并已完成复发或难治性多发性骨髓瘤(RRMM)的1期试验，并正处于针对非小细胞肺癌（NSCLC）和其他适应症的不同探索阶段。 “新药前沿”格言可靠地脚踏实地，更接近事实。往期推荐 01 First in Class心衰靶点RXFP1诺华、BMS失利后，礼来、AZ继续前行 02 让癌细胞分裂时“毙命”，KIF18A靶点启航本文由「新药前沿」微信公众号根据公开资料整理编辑，欢迎个人转发至朋友圈。媒体或机构转载授权请在「新药前沿」微信公众号留言公众号名称，审核通过后开通白名单获取转载授权，转载请标识来源。免责声明：本文仅作信息交流之目的，非投资建议或者治疗方案推荐，「新药前沿」微信公众号不对任何主体因使用本文内容而导致的任何损失承担责任。限于作者水平和专业知识所限，如有谬误，欢迎指正！

免疫疗法

2024-05-09

·药融圈

2次私有化的Biotech

▲5月30-31日第八届广州生物医药创新者峰会扫码立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。药融云数据（www.pharnexcloud.com）监测显示：赛生药业控股有限公司（6600.HK）（简称：赛生药业）是一家拥有产品开发和商业化集成平台的生物制药公司，战略上专注于在中国规模较大、增长迅速且存在巨大未被满足医疗需求的治疗领域，包括肿瘤科及重症感染。凭借赛生药业的产品开发及商业化实力，公司在重点治疗领域均衡和优质的上市产品及具有较佳潜力的在研产品的开发及商业化组合方面已建立良好的往绩记录。第一次私有化赛生药业前身是 SciClone US，最早成立于1990年，早期创始人为创始人Thomas E. Moore和Nelson M. Schneider；于1992 年在美国纳斯达克上市，是一家老牌上市公司。2013年新的中国管理团队加入公司，后公司在2017年被私有化。(2017年6月7日，由德福资本/GL发起、中银投资、鼎晖投资、上达资本、Boying Investment组成的买方财团Silver Biotech与SciClone US签订合并协议，以每股11.18美元的现金对价，收购SciClone US所有发行在外的普通股。)港股上市2021上市招股书，所示图片进展2021 年“全新”的赛生药业于中国香港上市，当时募集资金总额约为21.80亿港元。目前赛生药业三大业务：自有特色产品日达仙（胸腺法新的原研产品）(港股上市前2017~2019年间，日达仙分别实现销售额人民币11.26亿元、人民币11.68亿元和人民币13.49亿元)；授权引入候选新药产品（肿瘤与抗感染领域）；销售合作推广分销服务（辉瑞及百特成熟产品）。具体到新药引进/License-in合作开发方面：根据赛生药业2022年8月与美纳里尼亚太公司达成的许可及合作协议，赛生药业可根据美纳里尼与 Melinta Therapeutics, Inc. 此前签订的相关协议，在中国境内独家开发和商业化Vaborem®（注射用美罗培南韦博巴坦）。2023年3月，赛生药业递交的Vaborem®临床试验申请获得了中国国家药品监督管理局（NMPA）批准。Vaborem®在中国开展的III期临床试验于2023年7月完成首例受试者入组给药，并于2024年1月完成全部受试者入组。药融云数据www.pharnexcloud.com；截图来源该研究是在中国开展的一项随机、双盲双模拟、阳性药物对照(辉瑞的注射用哌拉西林钠他唑巴坦钠 )、多中心的III期临床试验，旨在评价Vaborem®在复杂性尿路感染（包括急性肾盂肾炎）患者中的有效性和安全性，由复旦大学附属华山医院王明贵教授和上海交通大学医学院附属仁济医院郑军华教授担任主要研究者，在全国27家研究中心共入组了108例受试者。该研究结果，及同时开展的一项在中国健康志愿者中评估Vaborem®药代动力学特征的研究结果，将用于桥接国外临床试验数据，并支持Vaborem®在中国的上市申请。其他新药布局：ORSERDU®（艾拉司群）ORSERDU®（艾拉司群）是一款口服选择性雌激素受体降解剂，用于治疗既往至少接受过一线内分泌治疗后疾病进展的雌激素受体1基因（ESR1）突变的雌激素受体（ER）阳性、人类表皮生长因子受体2（HER2）阴性晚期或转移性乳腺癌的绝经后女性和成年男性。Vibativ®(telavancin)Vibativ®是新型脂糖肽类抗生素，用于治疗金黄色葡萄球菌所致的医院获得性细菌性肺炎（HABP）与呼吸机相关细菌性肺炎（VABP），以及复杂性皮肤及皮肤软组织感染（cSSSIs）。RRx-001RRx-001是一款具有First-in-Class（FIC）潜质的小分子药物，具有多种作用机制，包括CD47-SIRPα靶向、RONs生成以及表观遗传调节。RRx-001可以对多种肿瘤微环境异常起到调节作用，包括：下调CD47-SIRPα, 使肿瘤相关巨噬细胞（TAM）复极化，由抗炎症M2表型转为促炎症 M1表型；通过表观遗传抑制活性激活抑癌基因，逆转化疗耐药；使肿瘤血管正常化以增加化疗药物渗透，产生代谢产物RONs导致肿瘤细胞坏死。OmburtamabOmburtamab是一种放射性核素碘131标记的靶向B7-H3（CD276）的单克隆抗体，靶向实体肿瘤中表达B7-H3的细胞，并结合到B7-H3分子上的生物功能的关键区域--FG环依赖型构象。药融云数据www.pharnexcloud.com；截图来源PEN-866PEN-866是一款小分子偶联药物，药物的一端为可靶向结合被激活的HSP90蛋白，另一端为拓扑异构酶抑制剂（SN-38）。PEN-866的独特桥接设计及细胞毒素释放机理使得SN-38可以特异性地在肿瘤部位聚集，同时随着连接分子的持续分解，持久地在肿瘤部位释放，并最终造成DNA的破坏及肿瘤的消退。PT-112这是一种创新型铂类小分子药物，通过细胞凋亡、免疫特性及高耐受性来抗肿瘤效果。PT-112的设计初衷是为了减少传统铂类药化疗中的毒性及耐药性。ABTL-0812这是一种具有独特作用机制的潜在候选药物。ABTL-0812通过与核受体PPARα和γ偶联来抑制PI3K/Akt/mTOR (PAM) 通路，从而诱导与Akt结合并阻碍其激活的假激酶TRIB3，并导致mTOR发生抑制，从而导致自噬依赖性癌细胞死亡。HSP90-PI3K偶联物HSP90-PI3K偶联物是一款小分子偶联药物，由磷脂酰肌醇3-激酶（PI3K）抑制剂、连接体与热休克蛋白90（HSP90）结合构成。再次被提出要约私有化2023财年，赛生药业营收为31.56亿元，同比增长约为14.8%；净利润同比增长增31.2%至11.2亿元。此前在2024年3月28日，德福资本及赛生药业联合公告：3月19日，要约人(Silver Pegasus Investment Limited)根据公司法第86条以协议安排方式将赛生药业私有化，要求董事会向计划股份持有人提呈建议，其中涉及注销计划股份，作为代价，就每股计划股份以现金向计划股东支付注销价（以换取每股计划股份现金18.8港元），并撤销股份于联交所的上市地位。注销价18.8港元较不受干扰日期收市价每股14.04港元溢价约33.90%，较最后交易日(2024年3月18日)收市价每股16.04港元溢价约17.21%。药融圈密切关注后续进展。参考：NMPA/CDE；药融云数据，www.pharnexcloud.com；FDA/EMA/PMDA；相关公司公开披露；www.sciclone.com；http://www.sciclone.com/Modules/research.aspx；https://pharma.bcpmdata.com/database/1/detail/39/Wsbrmo4B6rPXm79Mnp50?aliasId=d361ca6640；https://quote.eastmoney.com/hk/06600.html；等等。本文仅用于向医疗卫生专业人士提供科学信息，不代表平台立场，不作任何用药推荐活动推荐 5月 • 第八届大湾区生物医药创新者峰会关键词：小分子，XDC，多肽及GLP-1热点话题，80+行业专家（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

引进/卖出临床3期医药出海并购

2024-03-08

·PRNewswire

Promontory Therapeutics Completes Enrollment of Phase 2 Trial of PT-112 in Late-Line Patients with Metastatic Castration-Resistant Prostate Cancer

Ongoing clinical trial has reached target enrollment of 109 patients across clinical sites in the United States and France Open-label dose optimization and proof of concept study of PT-112 monotherapy includes interim data results, with top-line read-out and conference presentations expected in late 2024 NEW YORK, March 8, 2024 /PRNewswire/ -- Promontory Therapeutics Inc., a clinical stage pharmaceutical company advancing immunogenic small molecule approaches in oncology, has completed enrollment of its Phase 2 clinical trial of lead therapeutic candidate, PT-112, reaching its target enrollment of 109 patients with late-line metastatic castration-resistant prostate cancer (mCRPC) (ClinicalTrials.gov Identifier: NCT02266745). The study is evaluating PT-112 in patients who have been treated with at least three prior life-prolonging therapies for mCRPC, and who exhibited radiographic evidence of disease progression at study entry. Patients with bone-only metastatic disease are also included in the study. These requirements create a representative treatment population following standard of care of androgen receptor signaling inhibitors, taxane chemotherapies, and any other drug approved by FDA on the basis of overall survival. The clinical trial enrolled patients across leading sites in the United States (23) and France (9). "This clinical trial is the largest study to date of PT-112 and will establish the optimal dose in line with the FDA's Project Optimus, as well as proof of concept in our late-line mCRPC patient population," said Promontory Therapeutics Chief Medical Officer Johan Baeck, MD. "Data from our earlier Phase 1/2 studies have shown that PT-112 is clinically safe and active, and promotes immunogenic cancer cell death induced by the inhibition of ribosomal biogenesis, which is a promising mechanism of action for late-stage patients with prostate cancer — an 'immune-cold' disease with no broadly approved and effective immunotherapy." Promontory Therapeutics plans for a Type C meeting with the FDA in the second half of 2024, followed by an End-of-Phase 2 meeting with FDA and further engagement with European regulatory authorities. In addition to safety and efficacy findings among late-stage metastatic patients, the study aims to generate meaningful supportive data via correlative research, including on immune activation by PT-112 monotherapy as evaluated by the propagation of new T cell populations, as well as reductions in circulating tumor cells and ctDNA. "Promontory is grateful to our clinical partners across the U.S. and France, including Gustave Roussy Paris, for completing enrollment of this critical Phase 2 study. We are confident in PT-112's potential as an effective treatment for patients with mCRPC who have progressed on androgen receptor directed therapy, chemotherapy or radioligand therapy and who lack any effective immunotherapy," said Promontory Therapeutics Chief Executive Officer Robert Fallon. "We look forward to presenting topline safety, efficacy, and correlative data at relevant research and medical conferences later this year." About PT-112 PT-112 is the first small-molecule conjugate of pyrophosphate in clinical development in oncology. PT-112 has numerous advantages — including its tolerability and inhibition of ribosomal biogenesis which leads to immunogenic cell death, through the release of damage associated molecular patterns that bind to dendritic cells and lead to downstream immune effector cell recruitment in the tumor microenvironment. PT-112 represents a highly potent inducer of this immunological form of cancer cell death. Further, PT-112 harbors a property known as osteotropism, or the propensity of the drug to reach its highest concentrations in certain areas of the bone, making it a candidate for treatment of patients with cancers that originate in, or metastasize to, the bone. The ﬁrst in-human study of PT-112 demonstrated an attractive safety proﬁle and evidence of long-lasting responses among heavily pre-treated patients and data were published in eClinicalMedicine, part of The Lancet. The combination Phase 1b dose escalation study of PT-112 with PD-L1 checkpoint inhibitor avelumab in solid tumors was reported in a mini-oral presentation at the ESMO 2020 Virtual Congress, and the Phase 2a dose confirmation cohort in non-small cell lung cancer patients was reported at ESMO I-O 2022. The Phase 1 study in patients with relapsed or refractory multiple myeloma presented at ASH 2020 is the third completed Phase 1 study of PT-112. Monotherapy Phase 2 development is ongoing in mCRPC, and includes the Phase 2 proof of concept study in thymic epithelial tumors under the company's formal CRADA with the NCI. Interim data from the NCI study were published at ASCO 2023. About Promontory Therapeutics Promontory Therapeutics Inc. is a privately held, clinical stage pharmaceutical company focused on small molecule immunotherapy, based in New York City. Clinical data generated across three Phase 1 studies have demonstrated single-agent and combination anti-cancer activity and an attractive tolerability proﬁle, and two Phase 2 studies of PT-112 are underway. The company's research and development work has been conducted in the United States, Europe and Asia. The company sponsored the completed clinical study of PT-112 in combination with the PD-L1 inhibitor avelumab, and has an active Phase 2 trial under formal CRADA collaboration with the National Cancer Institute (NCI), utilizing PT-112 in thymic epithelial tumors, rare cancers with no FDA approved drug, where PT-112 has received Orphan Drug designation. Promontory Therapeutics is also a company member of the Paris-Saclay Cancer Cluster, Europe's emerging bio-cluster for oncology, and was a 2023 Nominee for Best Startup by the Prix Galien USA. To learn more about Promontory Therapeutics, visit the company's website here. CONTACTS: Promontory Therapeutics Brooke Raphael, MS VP, Strategy & Operations Tel: +1 (646) 974-6453 Email: [email protected] Investors: Stan Musial Tel: +1 (646) 222-6932 Email: [email protected] ICR Westwicke Media: Alexis Feinberg Tel: +1 (203) 939-2225 Email: [email protected] SOURCE Promontory Therapeutics Inc.

免疫疗法临床2期临床1期孤儿药临床结果

100 项与 PT-112 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
胸腺上皮肿瘤	临床2期	美国	National Cancer Institute	2022-04-06
肝细胞癌	临床2期	中国	SciClone Pharmaceuticals International (Cayman) Development Limited	2018-03-07
肝细胞癌	临床2期	中国	Lyophilization Technology, Inc.	2018-03-07
肝细胞癌	临床2期	中国	赛生医药江苏有限公司	2018-03-07
晚期恶性实体瘤	临床2期	法国	Promontory Therapeutics, Inc.	2014-07-01
晚期恶性实体瘤	临床2期	美国	Promontory Therapeutics, Inc.	2014-07-01
转移性去势抵抗性前列腺癌	临床2期	美国	Promontory Therapeutics, Inc.	2014-07-01
转移性去势抵抗性前列腺癌	临床2期	法国	Promontory Therapeutics, Inc.	2014-07-01
多发性骨髓瘤	药物发现	-	Promontory Therapeutics, Inc.	2018-02-07
非小细胞肺癌	药物发现	中国台湾	SciClone Pharmaceuticals International (Cayman) Development Limited	2016-08-01

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临床结果

适应症

分期

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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


NCT05104736 (Corporate Publications) 人工标引	临床2期	胸腺上皮肿瘤	11	PT-112	(憲衊廠鑰鹹願襯鏇顧夢) = 願簾願鑰選製衊築網遞鑰鹹鑰窪淵鬱夢鏇淵觸 (築獵顧構觸觸鹹簾遞觸 ) 更多	积极	2023-10-05
NCT05104736 (ASCO2023) 人工标引	临床2期	胸腺上皮肿瘤	10	PT-112	(鏇願顧艱構醖壓淵繭構) = 製鏇艱窪鬱淵獵壓鑰憲壓淵衊構築願窪鹹憲餘 (構鹽夢壓壓壓膚觸繭鬱 ) 更多	积极	2023-05-26
NCT03409458 (ESMO_IO2022) 人工标引	临床2期	非小细胞肺癌	18	PT-112+Avelumab 800 mg	(憲獵網獵選蓋繭構繭積) = Common treatment-related adverse events (TRAEs) were anemia (50%), fatigue (50%), thrombocytopenia (44%), nausea (44%) and anorexia (44%). 衊淵簾憲醖獵繭蓋鑰鏇 (簾顧蓋積醖選壓鏇膚淵 )	积极	2022-12-08
NCT02266745 (Pubmed) 人工标引	临床2期	晚期恶性实体瘤末线	66	PT-112	(夢壓衊蓋衊壓遞壓鬱獵) = 壓選鹹衊構獵衊選網糧製積蓋鹹製鑰鬱齋齋願 (願構遞膚遞艱醖選鑰遞 ) 更多	积极	2022-05-27
NCT03409458 (ESMO2020)	临床1期	实体瘤	36	PT-112 + Avelumab	(鏇鑰製範膚窪膚願積遞) = 28% 膚簾築積窪廠遞廠簾壓 (夢鹹觸鹹築蓋獵醖鹽襯 ) 更多	积极	2020-09-18
NCT03409458 \| NCT02266745 (ASCO_GU2020)	临床1/2期	转移性去势抵抗性前列腺癌	68	PT-112 monotherapy	(糧衊簾觸鏇製夢觸廠願) = The most common PT-112 TRAEs were fatigue (40%, Gr ≤2) with mono-Tx; fatigue (39%, Gr ≤2) with PAVE. 積襯鏇鏇鹽遞壓積構壓 (艱壓築構鹹窪淵壓製鬱 ) 更多	积极	2020-02-19
NCT03409458 \| NCT02266745 (ASCO_GU2020)	临床1/2期	转移性去势抵抗性前列腺癌	68	PT-112 in combination with avelumab		积极	2020-02-19
NCT02266745 (ESMO2018)	临床1期	HR阳性/HER2低表达实体瘤	62	PT-112	簾製襯鏇淵簾製鹽範願(夢夢夢積襯繭衊願觸積) = no significant acute neurotoxicity was reported in 533 infusions 鏇獵積艱艱製範繭構鹽 (顧膚繭繭膚積夢鹽簾鹹 ) 更多	积极	2018-10-22