A Phase I, Double Blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Orally Administered 'Ivaltinostat' Capsule in Healthy Male Volunteers

A Phase I, Double blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Orally Administered 'CG-745' Capsule in Healthy Male Volunteers

开始日期2023-03-09

申办/合作机构

Machaon Biotherapeutics

NCT05249101

/ Recruiting临床1/2期

A Phase 1b/2, Dose-escalation, Randomized, Multicenter Study of Maintenance Ivaltinostat Plus Capecitabine or Capecitabine in Patients with Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on FOLFIRINOX

This study is a Phase 1b/2, dose-escalation, randomized, multicenter study to assess the efficacy, safety, tolerability, and PK of ivaltinostat in combination with capecitabine and capecitabine monotherapy in patients with metastatic pancreatic adenocarcinoma whose disease has not progressed on a first line fluoropyrimidine-based chemotherapy (e.g., FOLFIRINOX).
In Phase 1b, 3 dose levels of ivaltinostat will be studied in combination with a fixed dose of capecitabine to determine the RP2D of ivaltinostat.
In Phase 2, patients will be randomized in a 1:1 ratio to the combination of ivaltinostat and capecitabine or to capecitabine monotherapy. A fixed dose for capecitabine 1000 mg/m2 orally twice daily will be taken on Days 1 to 14, and the RP2D of ivaltinostat will be administered intravenously once a week for 2 weeks, followed by 1 week of rest. One cycle consists of 21 days. Tumor response during study treatment will be assessed every 6 weeks up to Cycle 10, then every 9 weeks afterwards using RECIST v1.1 criteria.

开始日期2022-08-15

申办/合作机构

CG Pharmaceuticals, Inc.

NCT05345912

/ Completed临床1期

A Randomized, Double Blind, Placebo-controlled, Dose-escalation, Crossover Study to Compare and Evaluate the Pharmacokinetics and Safety of 'CG-745 IV' Intravenous Formulation and 'CG-750' Capsule Formulation in Healthy Male Adults

A randomized, placebo-controlled, dose-escalation, crossover study.

开始日期2019-12-16

申办/合作机构

CG Invites Co., Ltd.

100 项与 Ivaltinostat 相关的临床结果

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100 项与 Ivaltinostat 相关的转化医学

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100 项与 Ivaltinostat 相关的专利（医药）

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项与 Ivaltinostat 相关的文献（医药）

2024-04-01·British Journal of Clinical Pharmacology

Pharmacokinetics, pharmacodynamics and safety of oral formulation (CG‐750) of ivaltinostat, a histone deacetylase inhibitor, compared to IV formulation (CG‐745)

Article

作者: Huh, Ki Young ; Lee, SeungHwan ; Kim, Byungwook ; Yu, Kyung-Sang

AimsCG‐750 is an oral formulation of ivaltinostat, a newly developing histone deacetylase (HDAC) inhibitor. This study aimed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD) and safety of an oral formulation (CG‐750) of ivaltinostat compared to an intravenous (IV) formulation (CG‐745).MethodsA randomized, double‐blind, placebo‐controlled study was conducted in three cohorts. Subjects received either CG‐745 (Cohorts 1 and 3: 125 mg; Cohort 2: 250 mg) or placebo followed by CG‐750 (Cohort 1: 125 mg; Cohort 2: 375 mg; Cohort 3: 750 mg) or placebo. Blood samples for PK and PD assessment were collected up to 72 h post‐dose. Histone H3 acetylation at sites K9, K9/K14 and K27 was assessed for area under the % acetylation induction versus time curve (AUEC).ResultsA total of 25 subjects were randomized, and 23 subjects completed the study (Cohort 1, n = 6; Cohort 2, n = 6; Cohort 3, n = 6; placebo, n = 5). The mean bioavailability of CG‐750 was 10.6% (range: 4.18%–21.33%) and displayed linear PK in the dose range of 125–750 mg. The comparison of AUEC between formulations and the evaluation of the dose–AUEC relationship were inconclusive, due to the small sample sizes and significant variability observed in PD markers. All adverse events (AEs) were transient and of mild or moderate intensity.ConclusionsThe oral formulation of ivaltinostat (CG‐750) was generally well tolerated after a single dose. CG‐750 displayed a mean bioavailability of 10.6%.

2022-11-01·International Journal of Cancer

A phase I/II study of ivaltinostat combined with gemcitabine and erlotinib in patients with untreated locally advanced or metastatic pancreatic adenocarcinoma

Article

作者: Park, Jeong Youp ; Park, Seung Woo ; Jo, Jung Hyun ; Jung, Dawoon E. ; Lee, Hee Seung ; Park, Soo Been ; Bang, Seungmin ; Song, Si Young ; Chung, Moon Jae ; Cho, Sangsook

AbstractThis phase I/II study evaluated the safety and efficacy of a new histone deacetylase (HDAC) inhibitor, ivaltinostat, in combination with gemcitabine and erlotinib for advanced pancreatic ductal adenocarcinoma (PDAC). Patients diagnosed with unresectable, histologically confirmed PDAC who had not undergone previous therapy were eligible. Phase I had a 3 + 3 dose escalation design to determine the maximum tolerable dose (MTD) of ivaltinostat (intravenously on days 1, 8 and 15) with gemcitabine (1000 mg/m2 intravenously on days 1, 8 and 15) and erlotinib (100 mg/day, orally) for a 28‐day cycle. In phase II, patients received a six‐cycle treatment with the MTD of ivaltinostat determined in phase I. The primary endpoint was the objective response rate (ORR). Secondary endpoints included overall survival (OS), disease control rate (DCR) and progression‐free survival (PFS). The MTD of ivaltinostat for the phase II trial was determined to be 250 mg/m2. In phase II, 24 patients were enrolled. The median OS and PFS were 8.6 (95% confidence interval [CI]: 5.3‐11.2) and 5.3 months (95% CI: 3.7‐5.8). Of the 16 patients evaluated for response, ORR and DCR were 25.0% and 93.8% with a median OS/PFS of 10.8 (95% CI: 8.3‐16.7)/5.8 (95% CI: 4.6‐6.7) months. Correlative studies showed that mutation burden detected by cfDNA and specific blood markers such as TIMP1, pro‐MMP10, PECAM1, proMMP‐2 and IGFBP1 were associated with clinical outcomes. Although the result of a small study, a combination of ivaltinostat, gemcitabine and erlotinib appeared to be a potential treatment option for advanced PDAC.

2021-10-01·Hypertension1区 · 医学

Inhibition of HDACs (Histone Deacetylases) Ameliorates High-Fat Diet–Induced Hypertension Through Restoration of the MsrA (Methionine Sulfoxide Reductase A)/Hydrogen Sulfide Axis

1区 · 医学

Article

作者: Kim, InKyeom ; Jang, GiBong ; Jung, Jin Ki ; Park, Kwon Moo ; Kim, Jee In ; Yoon, Ga-Eun

Hydrogen sulfide (H 2 S) is an endogenous gaseous antioxidant and antihypertensive molecule produced during the homocysteine metabolism. MsrA (methionine sulfoxide reductase A) enables the metabolism of homocysteine by reducing methionine sulfoxide to methionine. Although HDAC (histone deacetylase) inhibition has been reported to show blood pressure lowering effects, their effects on endogenous H 2 S production are largely unknown. Here, we assessed the relevance of MsrA in high-fat diet (HFD)-induced hypertension and the effect of HDAC inhibition on MsrA expression, H 2 S production, and hypertension. Male C57BL/6 mice were fed a normal diet or HFD. HFD increased blood pressure and activities of HDAC3 and 6 but downregulated MsrA in the mesenteric arteries and the serum H 2 S level. HFD upregulated 4 hydroxynonenal, TNF (tumor necrosis factor)-α, and IL (interleukin)-6, and vasocontractile proteins. The histone H3 acetylation of the MsrA promoter was decreased by HFD. In hypertensive HFD-fed mice, administration of the HDAC inhibitor CG200745 lowered blood pressure and increased serum H 2 S level. CG200745 increased acetylation of histone H3 and MsrA levels in the mesenteric arteries while downregulating oxidative stress, inflammation, and vasocontractile proteins. Silencing of MsrA in the vascular smooth muscle cells recapitulated HFD-induced in vivo hypertensive effects. CG200745 increased the histone H3 acetylation of the MsrA promoter, MsrA expression, and H 2 S production in vascular smooth muscle cells, supporting the in vivo results. Collectively, HFD-induced downregulation of MsrA plays a pivotal role in HFD-induced hypertension by reducing H 2 S levels. MsrA expression is epigenetically regulated by HDAC inhibitors, providing HDAC inhibitors as a therapeutic option and MsrA and H 2 S as novel therapeutic targets. Graphic Abstract: An online graphic abstract is available for this article.

项与 Ivaltinostat 相关的新闻（医药）

2025-01-26

·药明康德

疾病控制率超95%的CLDN 18.2靶向疗法；可穿越血脑屏障的变构小分子痴呆症疗法…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 靶向CLDN18.2的抗体偶联药物（ADC）ATN-022用于治疗晚期或转移性胃癌，在一项1/2期临床试验中表现亮眼，CLDN 18.2高表达患者的疾病控制率（DCR）达95.2%。 2. 在研环肽疗法certepetide联合标准治疗（SoC）化疗及免疫治疗一线治疗局部晚期不可切除的胰腺导管腺癌（PDAC），16例接受4个周期治疗的患者中有9例达到部分缓解（PR），1例达到完全缓解（CR）。 3. 小分子TREM2激动剂VG-3927在1期临床试验中获得积极数据，在阿尔茨海默病（AD）患者脑脊液（CSF）中实现了高达约50%的游离TREM2（sTREM2）显著剂量依赖性降低。药明康德内容团队整理 ATN-022：公布在中国和澳大利亚开展的1/2期临床试验的新数据 Antennova公司在美国临床肿瘤学会胃肠道肿瘤研讨会（ASCO GI 2025）上公布了其正在中国和澳大利亚进行的1/2期研究CLINCH的最新数据，该研究评估了其靶向CLDN18.2的抗体偶联药物ATN-022在晚期或转移性胃癌患者中的治疗效果。Claudin是正常组织紧密连接中重要的一种蛋白质，具有4个跨膜结构域，它参与细胞旁通透性和电导等过程的调节。CLDN18.2在包含胃癌在内的消化道癌症中高度表达。因此，CLDN18.2为治疗胃癌、胰腺癌等实体肿瘤的有效靶标。截至2024年11月22日的数据，在剂量扩展研究中，CLDN 18.2表达为免疫组化（IHC）染色2+≥20%，且至少有1次肿瘤评估的21例胃癌患者中，总缓解率（ORR）达42.9%，DCR达95.2%，包括9例PR和11例疾病稳定（SD）的患者。在10例以1.8–2.4 mg/kg的有效剂量治疗，CLDN 18.2表达为IHC染色2+<20%的胃癌患者中，ORR为30.0%，包括1例CR和2例PR患者（均确认为CLDN 18.2表达为IHC染色2+<5%），DCR为50.0%。截至截止日期，CR患者已持久缓解超过14个月。总体来说，ATN-022在晚期胃癌患者中表现出可控的安全性和初步的抗肿瘤活性，且在不同CLDN18.2表达水平的患者中均显示出潜力，支持进一步在胃癌患者中进行临床研究。 Certepetide（LSTA1）：公布1b/2a期临床试验的初步数据 Lisata Therapeutics公司与非营利性临床研究组织WARPNINE Incorporated公布了1b/2a期临床试验iLSTA的初步结果。该试验评估了Lisata公司的在研环肽疗法certepetide联合标准治疗化疗及免疫治疗作为一线治疗，用于治疗局部晚期不可切除的胰腺导管腺癌患者的效果。Certepetide旨在激活一种肿瘤特异性的转运系统，使与之联合使用的全身性抗癌药物能够更有效地穿透肿瘤并在肿瘤内蓄积。此外，certepetide还被证明可以调节肿瘤微环境，使肿瘤对免疫疗法更加敏感。此次公布的结果显示，根据RECIST标准可评估的16例患者中，有5例在2个治疗周期后达到PR，其余11例患者达到SD。经过4个治疗周期后，16例患者中有9例患者达到PR，1例患者达到CR，其余6例患者保持SD。在完成4个治疗周期的17例患者中，有14例患者的CA19-9水平下降，其中6名患者的CA19-9水平降低>90%，8名患者降低>50%。5例接受重复活检的患者的结果显示，所有患者的肿瘤浸润淋巴细胞显著增加，基质浸润率为15%至50%。 VG-3927：公布1期临床试验的中期数据 Vigil Neuroscience公司宣布，其用以治疗阿尔茨海默病的在研小分子疗法VG-3927在1期临床试验中获得积极数据。VG-3927是一种口服生物利用度强的小分子TREM2激动剂。其作为激动剂和正变构调节剂（PAM）的新型作用模式可能会放大其在病灶部位的作用，从而强烈调节小胶质细胞并可能增强神经保护。VG-3927旨在增强小胶质细胞对聚集淀粉样蛋白和tau的保护性反应，同时不增加炎症反应。由于VG-3927不与sTREM2结合，与抗体TREM2激动剂相比，该疗法可最大限度地提高受体活化和小胶质细胞功能，这可能会增加其进入AD病灶的机会。此外，VG-3927没有Fc结构域，该结构域与免疫系统中与淀粉样蛋白相关成像异常（ARIA）风险增加相关的元素有关。此次公布的分析显示，VG-3927的脑部渗透性高，并展现出支持每日一次给药的良好且可预测的药代动力学（PK）特征。值得注意的是，该疗法在CSF中实现了高达约50%的sTREM2显著剂量依赖性降低，且显示出强劲的PK/药效学（PD）关系、持久的靶点结合能力以及TREM2激动剂活性。根据此积极结果，该公司预计于2025年第三季度启动VG-3927的2期试验。根据新闻稿，VG-3927是首个准备进入2期临床的每日一次口服TREM2小分子激动剂。 Ozekibart（INBRX-109）：公布1期临床试验的初步数据 Inhibrx Biosciences公司公布了ozekibart（INBRX-109）联合FOLFIRI治疗晚期或转移性不可切除的结直肠癌（CRC）的1期临床试验的初步疗效和安全性数据。Ozekibart是一种经过精密设计的四价死亡受体5（DR5）激动剂抗体，旨在利用DR5激活诱导的肿瘤偏向性细胞死亡。2021年1月，美国FDA授予ozekibart快速通道资格，用于治疗转移性或不可切除的传统软骨肉瘤患者。2021年11月，FDA授予ozekibart用于治疗软骨肉瘤的孤儿药资格。此次公布的结果显示，在10名疗效可评估的患者中，观察到1例CR、3例PR和6例SD，46.2%的患者实现了持续≥180天的疾病控制，中位无进展生存期（PFS）为7.85个月。值得注意的是，达到CR的患者既往接受过3线治疗，其中2例PR发生在既往接受基于FOLFIRI治疗后失败的患者中。安全性方面，大多数治疗伴发不良事件（TEAE）为低级别，≥3级TEAE的发生率为30.8%。 Ivaltinostat：公布1b/2期联合治疗试验数据 CG Pharmaceuticals公司公布了ivaltinostat用于治疗转移性PDAC的1b/2期临床试验结果。在这项1b期研究中，28名接受过至少一线治疗的局部晚期或转移性PDAC患者接受了3种不同剂量的ivaltinostat联用卡培他滨。Ivaltinostat是一种表观遗传靶向的HDAC抑制剂，与其他同类在研药物相比，ivaltinostat显示出优异的安全性和药代动力学特性。截至2024年12月28日的数据，28名患者中有7名仍然存活，18名死亡（全部由于停止研究后疾病进展，没有与研究治疗直接相关的死亡），1名失访，2名退出研究。存活时间最长的患者已存活27个月，最长治疗持续时间为20个月。在总共28名患者中，65%显示SD或没有疾病证据，14%出现疾病进展，22%未接受评估。 ATTO-1310：1期临床试验完成首例患者给药 Attovia Therapeutics公司宣布，其用于治疗不明原因慢性瘙痒症（CPUO）等瘙痒症的全身治疗药物ATTO-1310的首次人体1期研究已完成首例受试者给药。ATTO-1310基于该公司专有的生物制品平台ATTOBODY开发，是一种新型皮下（SQ）给药、半衰期延长（HLE）的抗IL-31疗法。该公司的ATTOBODY平台通过专有的连接技术能够将两个与同一靶点蛋白两个不同表位结合的抗体片段连接起来，构成双互补位生物制品（biparatopic biologics）。ATTOBODY具有多种优势，包括可与靶点以皮摩尔的亲和力结合，并且亲和力可以调节，从而获得优化的药代动力学特征。此外，它具有模块化结构，可以将不同ATTOBODY模块结合在一起构建多特异性生物制品。此外，ATTOBODY可以和各种不同延长半衰期的片段融合，根据需要延长生物制品的半衰期，甚至具有每三个月给药一次的潜力。 CG001419：启动1期临床试验给药 Cullgen公司宣布启动CG001419的人体试验。该公司的泛素介导的小分子诱导靶标消除技术（uSMITE）平台能够让药物设计范式超越功能位点抑制，让“难以靶向”的酶和蛋白质调控成为可能。其开发的CG001419是一种潜在“first-in-class”的口服泛TRK蛋白降解剂，旨在选择性降解突变型和野生型TRK蛋白。该疗法正在被开发为一种非阿片类、非非甾体抗炎药的新镇痛疗法，并有望降低与其他药物治疗疼痛相关的成瘾风险。 ▲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（可上下滑动查看） [1] Antennova Presents Latest Phase I/II Data on ATN-022 in Advanced/Metastatic Gastric Cancer, Including an ORR of 42.9%, at ASCO GI 2025. Retrieved January 24, 2025, from https://www.prnewswire.com/news-releases/antennova-presents-latest-phase-iii-data-on-atn-022-in-advancedmetastatic-gastric-cancer-including-an-orr-of-42-9-at-asco-gi-2025--302356818.html [2] Inhibrx Biosciences Announces Preliminary Data from the Phase 1 Trial of ozekibart (INBRX-109) for the Treatment of Colorectal Cancer. Retrieved January 24, 2025, from https://www.prnewswire.com/news-releases/inhibrx-biosciences-announces-preliminary-data-from-the-phase-1-trial-of-ozekibart-inbrx-109-for-the-treatment-of-colorectal-cancer-302356540.html [3] Lisata Therapeutics and WARPNINE Announce Encouraging Preliminary Results from the Phase 1b/2a iLSTA Trial Evaluating Certepetide in Locally Advanced Non-Resectable Pancreatic Ductal Adenocarcinoma. 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Retrieved January 23, 2025 from https://www.globenewswire.com/news-release/2025/01/23/3014360/0/en/LAPIX-Therapeutics-Doses-First-Patient-In-Phase-1b-Clinical-Trial-of-LPX-TI641-for-Rheumatoid-Arthritis-RA-and-Psoriatic-Arthritis-PsA.html [10] Kiromic BioPharma Reports Tumor Volume Decrease in Two Patients Enrolled in Deltacel-01. Retrieved January 24, 2025, from https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-reports-tumor-volume-decrease-two-patients [11] EXUMA Biotech Announces Phase 1 Results for its Autologous HER2 Directed, Tumor Metabolism Regulated (TMR) CAR-T Product at ASCO GI 2025. Retrieved January 24, 2025, from https://www.prnewswire.com/news-releases/exuma-biotech-announces-phase-1-results-for-its-autologous-her2-directed-tumor-metabolism-regulated-tmr-car-t-product-at-asco-gi-2025-302358845.html [12] Century Therapeutics Announces Investigator-Initiated Phase 1/2 Trial of its iPSC-derived iNK Cell Therapy CNTY-101 in B-cell Mediated Autoimmune Diseases Sponsored by Internationally Renowned Key Opinion Leaders. Retrieved January 24, 2025, from https://investors.centurytx.com/news-releases/news-release-details/century-therapeutics-announces-investigator-initiated-phase-12 [13] ORYZON announces first patient dosed in an Investigator-initiated Phase I study of iadademstat in myelodysplastic syndrome. Retrieved January 24, 2025, from https://www.oryzon.com/en/news-events/news/oryzon-announces-first-patient-dosed-investigator-initiated-phase-i-study [14] Attovia Therapeutics Announces First Participant Dosed in First-in-Human Phase 1 Study of ATTO-1310, its Novel Half-life Extended Anti-IL-31 ATTOBODY for the Treatment of Chronic Pruritus. Retrieved January 24, 2025, from https://www.globenewswire.com/news-release/2025/01/23/3014175/0/en/Attovia-Therapeutics-Announces-First-Participant-Dosed-in-First-in-Human-Phase-1-Study-of-ATTO-1310-its-Novel-Half-life-Extended-Anti-IL-31-ATTOBODY-for-the-Treatment-of-Chronic-Pr.html [15] BlossomHill Therapeutics Doses Patients in the First Cohort of the Phase 1/2 SOLARA Clinical Trial of BH-30643 for EGFR- and HER2-Mutated Non-Small Cell Lung Cancer. Retrieved January 24, 2025, from https://www.businesswire.com/news/home/20250122706462/en 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

临床结果ASCO会议抗体药物偶联物免疫疗法临床2期

2025-01-24

·PRNewswire

CG Pharmaceuticals: Progress of U.S. Phase 1b/2 Metastatic Pancreatic Cancer Clinical Trial at the ASCO Gastrointestinal Symposium

ORINDA, Calif., Jan. 23, 2025 /PRNewswire/ -- CG Pharmaceuticals (CG Pharma), a clinical biopharmaceutical company located in the San Francisco Bay Area, was established as an independent entity in 2024 after licensing ivaltinostat from CG Invites. The company has since been conducting various research projects on ivaltinostat in the U.S. including the metastatic pancreatic cancer (mPDAC) clinical trial (NCT05249101). The results of the completed Phase 1b study and the progress report of Phase 2 will be presented at the ASCO Gastrointestinal Symposium on Friday, January 24. In the Phase 1b study, a total of 28 patients with locally advanced or metastatic PDAC who had received at least one prior line of therapy were administered ivaltinostat at 3 different dose levels (60, 125 and 250 mg/m² on days 1 and 8) in combination with capecitabine (1000 mg/m², administered twice daily on days 1-14) of a 21-day cycle. Treatment-emergent adverse event (TEAE) profile was similar across dose levels, with the most common TEAEs (primarily grade 1-2) including fatigue, nausea, palmar-plantar erythrodysesthesias, constipation, and diarrhea. No serious adverse events that were related to ivaltinostat occurred in any of the 3 dose cohorts. At the time of data cutoff (12/28/2024), there were 7 patients still alive, 18 deaths (all due to disease progression after discontinuation from study; no deaths directly related to study treatment), 1 patient lost to follow-up, and 2 study withdrawals. The longest-surviving patient has been alive for 27 months and the maximum duration of treatment was 20 months. Two thirds (65%) from a total of 28 patients showed stable disease or no evidence of disease, 14% experienced disease progression, and 22% were not evaluated. The safety and efficacy results of the Phase 1b clinical study demonstrated that ivaltinostat can be effectively combined with cytotoxic chemotherapy to treat mPDAC. With the RP2D of ivaltinostat established at 250 mg/m2 from Phase 1b, this combination is now being evaluated in the Phase 2 randomized portion of the study comparing ivaltinostat plus capecitabine versus capecitabine alone in the maintenance setting for patients with mPDAC who underwent first line fluoropyrimidine-based therapy for at least four months without disease progression in terms of Progression-Free Survival and Overall Survival. The ongoing Phase 2 trial began patient enrollment in January 2024 and has already achieved over 62% of its target enrollment across 17 U.S. clinical trial sites. CG Pharma anticipates completing Phase 2 patient enrollment and follow-ups this year, with a final clinical study report expected by mid-2026. Ivaltinostat: A Promising New Approach Ivaltinostat, an epigenetic-targeting HDAC inhibitor, has shown exceptional safety and pharmacokinetic profiles compared to other investigational agents in its class. Metastatic pancreatic cancer remains a deadly malignancy with limited treatment options, underscoring the urgent need for innovative therapies like ivaltinostat. Leadership Statements: Dr. Joong Myung Cho, founder of CrystalGenomics and majority shareholder of CG Pharma, highlighted the significance of addressing unmet medical needs through the development of new therapies like ivaltinostat: "For 40 years, I have been dedicated to developing innovative treatments for diseases with limited therapeutic options. Our Phase 2 trial for metastatic pancreatic cancer is progressing smoothly, and we look forward to sharing top-line results soon." Dr. Gene Cho, CG Pharma's Vice President of Global Strategy, remarked: "We are actively engaging with partners and investors to support CG Pharma's success. Exciting updates are forthcoming." Forward-Looking Statement Disclosure: This press release may contain certain forward-looking statements relating to the goals, business strategy, financial and market position, product development, and projections for the Company. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statements can be guaranteed, and actual results may differ. The information in this release is provided only as of the written date, and CG Pharmaceuticals undertakes no obligation to update any forward-looking statements contained in this release, except as required by law. Contact: Gene Young Cho, Ph.D. Vice President of Global Strategy at CG Pharmaceuticals, Inc. Phone: 925-259-7333 Mobile: 925-899-9637 Email: [email protected] SOURCE CG Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床1期临床2期临床结果

2024-05-29

·PRNewswire

CG Pharmaceuticals Prepares to Showcase Its Ongoing Phase 2 Study for Ivaltinostat in Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)

ORINDA, Calif., May 29, 2024 /PRNewswire/ -- CG Pharmaceuticals, a company dedicated to advancing innovative therapies to improve the lives of patients with cancer, prepares to showcase its advancements in metastatic PDAC therapy. The study design of a randomized multi-center Phase 2 US clinical trial, which is actively enrolling patients, is scheduled to be presented on June 1st, 1:30 – 4:30 PM CDT at the ASCO Annual Meeting (ClinicalTrials.gov NCT05249101). "Metastatic PDAC continues to be an aggressive cancer with limited treatment options. We are pleased that CG Pharmaceuticals is investing in pancreatic cancer research and look forward to the results of their trial," said Anna Berkenblit, MD, MMSc, Chief Scientific and Medical Officer at the Pancreatic Cancer Action Network (PanCAN). "Clinical trials are an important aspect of accelerating new developments that improve outcomes for pancreatic cancer patients. PanCAN recommends that patients with PDAC consider participating in clinical trials." In the Phase 1b study, 28 patients with locally advanced or metastatic PDAC who had received at least one prior line of therapy were administered ivaltinostat at three dose levels (60, 125, and 250 mg/m²) in combination with capecitabine. The study demonstrated a favorable safety profile, with no treatment-related serious adverse events. At the time of data cutoff (5/6/2024), 16 patients were alive with 3 patients continuing treatment, and 7 patients were treated for longer than 6 months with the longest duration of treatment of 16 months. The Phase 2 study compares the efficacy of ivaltinostat/capecitabine combination therapy versus capecitabine monotherapy in metastatic PDAC patients who have shown no evidence of disease progression after first-line chemotherapy. Efficacy endpoints include progression-free survival, objective response rate, disease control rate, and overall survival. About Ivaltinostat: Ivaltinostat is a potential first-in-class novel therapeutic candidate for PDAC that inhibits enzymatic activity of histone deacetylase and has been evaluated for solid tumors and hematologic malignancies. CG Pharmaceuticals continues to make strides in its mission to provide innovative treatment options for metastatic PDAC patients. Forward-Looking Statement Disclosure: This press release may contain certain forward-looking statements relating to the goals, business strategy, financial and market position, product development, and projections for the Company. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them. No forward-looking statements can be guaranteed, and actual results may differ. CG Pharmaceuticals undertakes no obligation to update any forward-looking statements contained in this release, except as required by law. CG Pharmaceuticals Contact: Douglas An Head of Finance and IR Representative [email protected] SOURCE CG Pharmaceuticals, Inc.

临床2期临床1期临床结果

100 项与 Ivaltinostat 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB12259

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
转移性胰腺腺癌	临床2期	美国	CG Pharmaceuticals, Inc.	2022-08-15
急性髓性白血病	临床2期	韩国	CG Invites Co., Ltd.	2022-01-30
新型冠状病毒感染	临床2期	韩国	CG Invites Co., Ltd.	2022-01-30
肝细胞癌	临床2期	韩国	CG Invites Co., Ltd.	2022-01-30
骨髓增生异常综合征	临床2期	韩国	CG Invites Co., Ltd.	2022-01-30
胰腺导管腺癌	临床2期	韩国	CG Invites Co., Ltd.	2022-01-30
特发性肺纤维化	临床前	美国	CG Invites Co., Ltd.	2023-01-03
转移性胰腺癌	临床前	韩国	CG Invites Co., Ltd.	2016-03-01
晚期恶性实体瘤	临床前	韩国	CG Invites Co., Ltd.	2010-09-01

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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


NCT05249101 (ASCO_GI2025) 人工标引	临床1期	转移性胰腺腺癌维持	28	Ivaltinostat + Capecitabine	(鹽選築鹹顧膚鬱壓選積) = 餘鏇鏇簾鏇鹽鏇憲壓築遞齋遞齋壓壓觸選鹹襯 (襯壓鹹製淵齋廠範築夢 ) 更多	积极	2025-01-23
NCT05249101 (ASCO_GI2024) 人工标引	临床1期	转移性胰腺腺癌维持	32	Ivaltinostat + capecitabine	(遞範醖鑰觸餘鹹遞窪艱) = 觸積選網繭鏇鏇選鹹廠鹽壓繭築夢鹹範蓋衊遞 (網醖憲繭艱顧獵鬱廠構 ) 更多	积极	2024-01-18
SP071 (ERA2018)	N/A	高血压	-	CG200745	(膚顧築觸窪夢願網築鏇) = 築鹹鑰鹽糧遞蓋願襯觸夢廠壓獵網衊衊觸選夢 (選構醖網積構糧蓋膚簾 )	积极	2018-05-18
SP071 (ERA2018)	N/A	高血压	-	CG200745 (Control)	(膚顧築觸窪夢願網築鏇) = 鹽壓願鬱憲獵糧廠艱鏇夢廠壓獵網衊衊觸選夢 (選構醖網積構糧蓋膚簾 )	积极	2018-05-18
ASCO2012	临床1期	HR阳性/HER2低表达实体瘤	-	CG200745	(鑰獵糧襯憲築醖憲鹹鹹) = 構築鏇衊衊鹹襯鬱獵觸衊築鹽選艱遞蓋膚鏇製 (繭繭廠築選憲範簾蓋壓 ) 更多	-	2012-05-20