A Phase-2, Open-label, Randomized, Parallel-Group, Three-Arm Study to Assess Efficacy and Safety of Cabazitaxel Lipid Tablet in Combination with Prednisone for the Treatment of Adult Men with Metastatic Castration-Resistant Prostate Cancer Previously Treated with a Docetaxel-containing Treatment Regimen

A total of 75 participants will be enrolled in the study, with 25 participants allocated per intervention group. In Group 1, participant will take 50 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 2, participant will take 100 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 3, participant will take 200 mg cabazitaxel every 3 weeks for 6 cycles (1 doses per cycle), 10 mg prednisone daily till the end of cycle 6.
The study comprises three phases: a 21-day screening phase, an 18-week intervention phase starting on Day 1 (baseline), and a post-intervention follow-up phase lasting up to 12 months from Day 1. The total duration of participation for each individual will be approximately one year.
Key efficacy assessments include CT scans/MRI, bone scans, PSA, ALP, LDH, symptomatic skeletal events, and pain evaluations. Key safety assessments encompass the monitoring of adverse events (AEs), ECOG performance status, physical examinations, vital sign measurements, clinical laboratory tests, peripheral neuropathy evaluation, 12-lead ECG, and echocardiogram (ECHO) assessments.
Pharmacokinetic parameters will also be evaluated.

开始日期2025-05-01

申办/合作机构

Jina Pharmaceuticals, Inc.

NCT06867042

/ Not yet recruiting临床2期

A Double-blind, Randomized, Multicenter, Parallel, Placebo-controlled Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Tacrolimus Lipid Suspension for Enema in Adult Subjects with Mild to Moderately Active Left-sided/Distal Ulcerative Colitis Who Had an Inadequate Response to the Treatment

The study will evaluate the effectiveness, safety and tolerability of tacrolimus lipid suspension for enema in adult patients with mild to moderately active ulcerative colitis who had an inadequate response or intolerance of at least 1 of aminosalicylates (5-ASAs), corticosteroids, azothiopurine, mercaptopurine and methotrexate and need an alternative therapy. There will be approximately 150 male and female subjects of 18 and 65 years of age enrolled. Patients will be randomized into two groups where Tacrolimus Lipid Suspension for Enema or Placebo (Tacrolimus-free) Lipid Suspension for Enema will be administered rectally once daily for 28 days.

开始日期2025-04-01

申办/合作机构

Jina Pharmaceuticals, Inc.

[+1]

NCT06867562

/ Not yet recruiting临床3期

A Phase-3, Randomized, Parallel Group, Open-label, Multicenter, Two-Arm Treatment Study to Evaluate the Efficacy and Safety of Weekly Paclitaxel Lipid Suspension Compared with Weekly Conventional Paclitaxel in the Patients with Platinum-Resistant/Refractory Recurrent High-grade Serous Epithelial Ovarian Cancer Including Fallopian Tube And/or Primary Peritoneal Cancer

This is a phase-3, open-label, multicenter, two-arm treatment study to evaluate the efficacy and safety of weekly Paclitaxel Lipid Suspension compared with weekly conventional paclitaxel in participants with platinum-resistant/refractory recurrent high-grade serous epithelial ovarian cancer.
Paclitaxel Lipid Suspension or conventional paclitaxel will be administered intravenously at a dose level of 80 mg/m2 on Day 1, Day 8 and Day 15 of each 28 days cycle.
The primary objective is to establish the non-inferiority of Paclitaxel Lipid Suspension in comparison with conventional paclitaxel for Injection in participants with platinum-resistant/refractory recurrent advanced high-grade serous epithelial ovarian cancer including fallopian tube and/or primary peritoneal cancer.
Participants in both arms will be dosed with the drug until disease progression as assessed by investigator and/or unacceptable toxicity.

开始日期2025-04-01

申办/合作机构

Jina Pharmaceuticals, Inc.

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项与 Jina Pharmaceuticals, Inc. 相关的文献（医药）

2025-02-10·Journal of Clinical Oncology

Efficacy and safety of nanosomal docetaxel lipid suspension in Indian patients with metastatic castration-resistant prostate cancer (mCRPC): A multicenter, open-label, single-arm phase 4 study.

作者: Mohapatra, Prabrajya NARAYAN ; Nemade, Bhushan Tapiram ; Kulkarni, Padmaj Sudhakar ; Chaturvedi, Alok ; Mishra, Sourav Kumar ; Das, Chandan Krushna ; Ahmad, Imran ; Reddy, Rakesh ; Ali, Shoukath M ; Parimkayala, Radhika ; Ghadyalpatil, Nikhil ; Bunger, Deepak ; Sheikh, Saifuddin ; Rajani, Anil ; Ganta, Ranga Raman ; Sood, Rajeev ; Paithankar, Mahesh ; Vaswani, Bharat ; Ahmad, Ateeq ; James, Francis

168Background: Docetaxel combined with prednisone is the first line chemotherapy to improve overall survival in metastatic castration resistant prostate cancer (mCRPC). Nanosomal docetaxel lipid suspension (NDLS) is a novel formulation that eliminates the need for polysorbate 80 and ethanol, reducing infusion-related reactions and the requirement for steroid premedication. This phase 4 trial aims to assess the efficacy and safety of NDLS in patients with mCRPC. Methods: In this multicenter, open-label, single-arm trial, patients with confirmed mCRPC and at least one measurable lesion were enrolled. Exclusions included those with brain lesions or a history of hypersensitivity to taxanes. NDLS was administered at 75 mg/m 2 every three weeks for 10 cycles without steroid premedication. The primary endpoint was the overall response rate (ORR) upon completion of 10 cycles. Results: Between July 2018 and July 2023, 86 patients (safety set) received the study drug. The modified intention-to-treat (mITT) set (included 77 patients who received at least one dose and had at least one efficacy evaluation). The mean age of the mITT set was 67 (±6.2) years, with a median prostate specific antigen (PSA) value of 31.3 ng/mL. At the end of 10 cycles, the overall response rate (ORR) was 16.9% (95% CI: 9.31, 27.14), and the disease control rate (DCR) was 44.2% (95% CI: 32.84, 55.93). A ≥50% reduction in serum PSA was observed in 36 (46.8%) patients. The visual analog score (VAS) decreased significantly from baseline with a mean difference of 12.8 mm (P<0.0001). Median progression free survival (PFS) was 12 months (95% CI: 8.12, 18.12), and the overall survival rates at 1 and 2 years were 31.2% and 19.5% respectively. Adverse events were reported in 64 (84.4%) patients, with only one patient experiencing a grade ≥3 adverse event. Common grade 1/2 adverse events (≥10% of patients) included diarrhea, vomiting, asthenia, alopecia, headache, anemia, fever, infections, and pain. Conclusions: NDLS showed efficacy and safety in patients with metastatic castration-resistant prostate cancer. Clinical trial information: CTRI/2018/02/012212 . Efficacy outcomes at cycle 10 completion.ParametermITT set (N=77)PR, n (%)13 (16.9)SD, n (%)21 (27.3)ORR, (95% CI)16.9% (9.31, 27.14)DCR, (95% CI)44.2% (32.84, 55.93)BOR, (95% CI)26.0% (16.64, 37.23)≥50% reduction in serum PSA, n (%)36 (46.8)Change from baseline for VAS (mm), mean (±SD)12.8 (±22.11) (p<0.0001)Median PFS (months), (95% CI)12 (8.12, 18.12)Median OS (months)Not reached

PR: partial response; SD: stable disease; BOR: Best overall response.

2024-01-20·Journal of Clinical Oncology

Safety and efficacy of nanosomal docetaxel lipid suspension (NDLS) in patients with advanced gastric adenocarcinoma.

作者: Ghosh, Joydeep ; Raghu Raman, Ramaiyer ; Nemade, Bhushan Tapiram ; Ahmad, Imran ; Panda, Soumya Surath ; Reddy, Rakesh ; Ali, Shoukath M ; Ostwal, Vikas S. ; Sheikh, Saifuddin ; Paithankar, Mahesh ; Seshachalam, Arun ; Patel, Lav ; Bunger, Deepak ; Srinivas, B. J. ; Rajani, Anil ; Kota, Rajesh ; Agarwal, Amit ; Ahmad, Ateeq ; SHARMA, ATUL ; K, Lakshmi Priyadarshini

348 Background: Nanosomal docetaxel lipid suspension (NDLS) was developed to overcome toxicity issues associated with conventional docetaxel. Docetaxel, cisplatin, 5-fluorouracil (5-FU; DCF) or modified DCF (mDCF) is one of the recommended first-line regimens for patients with metastatic gastric adenocarcinoma (GAC). However, majority of the patients experienced grade 3/4 toxicities with DCF regimen using conventional docetaxel. The present study evaluated the safety and efficacy of NDLS-based mDCF/DCF regimens in patients with metastatic GAC. Methods: In this multicentric, open-label, clinical trial, patients with previously untreated metastatic GAC were enrolled. Patients received either mDCF [NDLS 40 mg/m2 on day 1 (D1), C 40 mg/m2 on D2 or D3, 5-FU 400 mg/m2 bolus on D1, leucovorin 400 mg/m2 on D1, 5-FU 1000 mg/m2/day continuous infusion D1 & 2; q2w] for 9 cycles, or DCF [NDLS 75 mg/m2 on D1, C 75 mg/m2 on D1, 5-FU 750 mg/m2/day for 5 days given as continuous infusion; q3w] for 6 cycles. Prophylactic GCSF (Granulocyte Colony Stimulating Factor)/Peg-GCSF support was allowed in all patients. The primary endpoint was overall response rate (ORR) at week 18. Secondary endpoints were disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety outcomes. Patients were followed up to 1 year. Results: Fifty-two patients were enrolled, with mean (±SD) age of 52 (±9.6) years & male:female ratio of 32:20. Thirty-eight patients qualified for modified intent-to-treat (mITT) analysis for efficacy evaluation (mDCF: 33; DCF:5). At week 18, ORR was 57.9% & DCR was 81.6% in mITT population. In the per-protocol population (n=26), ORR was 61.5% at 18 weeks (mDCF:63.6%; DCF:50%). Safety set included all 52 patients. Any grade adverse events (AEs) were reported in 90.4% (n=47) of the patients; with 40.4% experiencing grade 3/4 AEs. All-grade AEs reported in ≥10% of the patients included anemia, neutropenia, abdominal pain, diarrhea, nausea, vomiting, fatigue, mucositis, decreased appetite, peripheral neuropathy; with majority of AEs being grade 1/2. Most common grade 3/4 AE was neutropenia; observed in 17.3% (n=9) patients (mDCF: 14%; DCF: 33.3%). Conclusions: NDLS-based regimens demonstrated efficacy & improved safety profile in the treatment of metastatic GAC. Clinical trial information: CTRI/2018/01/011450 . [Table: see text]

2024-01-01·Therapeutic Advances in Medical Oncology

Treatment with nanosomal paclitaxel lipid suspension versus conventional paclitaxel in metastatic breast cancer patients – a multicenter, randomized, comparative, phase II/III clinical study

Article

作者: Nagarkar, Rajnish Vasant ; Srinivasan, Krishnan ; Rajani, Anil ; Chaturvedi, Alok ; Mukherjee, Kalyan Kusum ; Ali, Shoukath M. ; Satheesh, Chiradoni Thungappa ; Vithalani, Nikunj K. ; Ahmad, Imran ; Mehta, Ajay Omprakash ; Paithankar, Mahesh ; Maksud, Tanveer ; Taran, Rakesh ; Patel, Ronak ; Bunger, Deepak ; Sonawane, Satish Ramkrishna ; Sheikh, Saifuddin ; Shrivastav, Shanti Prakash ; Patel, Lav ; Singh, Jitendra Kumar ; Ahmad, Ateeq ; Vikranth, Mummaneni

Background: A novel nanosomal paclitaxel lipid suspension (NPLS), free from Cremophor EL (CrEL) and ethanol, was developed to address the solvent-related toxicities associated with conventional paclitaxel formulation. Objective: To evaluate the efficacy and safety of NPLS versus CrEL-based paclitaxel (conventional paclitaxel) in patients with metastatic breast cancer (MBC). Design: A prospective, open-label, randomized, multiple-dose, parallel, phase II/III study. Methods: Adult (18–65 years) female patients with MBC who had previously failed at least one line of chemotherapy were randomized (2:2:1) to NPLS 175 mg/m2 every 3 weeks (Q3W, n = 48, arm A), NPLS 80 mg/m2 every week (QW, n = 45, arm B) without premedication or conventional paclitaxel (Taxol®, manufactured by Bristol-Myers Squibb, Princeton, NJ, USA) 175 mg/m2 Q3W ( n = 27, arm C) with premedication. In the extension study, an additional 54 patients were randomized (2:1) to arm A ( n = 37) or arm C ( n = 17). Results: Pooled data from the primary study and its extension phase included 174 patients. The primary endpoint was the overall response rate (ORR). As per intent-to-treat analysis, ORR was significantly better in the NPLS QW arm as compared to conventional paclitaxel [44.4% (20/45) versus 22.7% (10/44), ( p = 0.04)]. An improvement in ORR with NPLS Q3W versus conventional paclitaxel arm [29.4% (25/85) versus 22.7% (10/44)] ( p = 0.53) was observed. Disease control rates observed were improved with NPLS Q3W versus conventional paclitaxel Q3W (77.7% versus 72.7%, p = 0.66) and with NPLS QW versus conventional paclitaxel Q3W (84.4% versus 72.7%, p = 0.20), although not significant. A lower incidence of grade III/IV peripheral sensory neuropathy, vomiting, and dyspnea was reported with NPLS Q3W versus conventional paclitaxel Q3W arms. Conclusion: NPLS demonstrated an improved tumor response rate and a favorable safety profile versus conventional paclitaxel. NPLS 80 mg/m2 QW demonstrated a significantly better response versus conventional paclitaxel 175 mg/m2 Q3W. Trial registration: Clinical Trial Registry-India (CTRI), CTRI/2010/091/001344 Registered on: 18 October 2010 (https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MjEzNQ==&Enc=&userName=CTRI/2010/091/001344), CTRI/2015/07/006062 Registered on: 31 July 2015 (https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTE2Mjc=&Enc=&userName=CTRI/2015/07/006062)

项与 Jina Pharmaceuticals, Inc. 相关的新闻（医药）

2024-01-18

·CPHI制药在线

FDA批准的癌症新药Nirogacestat，NCCN指南1类推荐

关注并星标CPHI制药在线美国国家综合癌症网络（National Comprehensive Cancer Network，NCCN）日前公布的最新版相关指南显示，基于FDA日前的批准，作为硬纤维瘤患者全身治疗选择的γ分泌酶抑制剂Nirogacestat（Ogsiveo），被授予首选的1类推荐。 Nirogacestat被纳入美国重磅NCCN指南并且1类推荐，成为本药的又一重要里程碑，为临床用药增添新证。NCCN软组织肉瘤指南（2023-12月发布）图片来源：NCCN官网 1.1 Nirogacestat简介 Nirogacestat于2023年11月27日首次美国获批上市，FDA 此前授予该药用于治疗硬纤维瘤的突破性疗法、快速通道和孤儿药资格。根据FDA新闻稿，该药是首个被批准用于治疗硬纤维瘤患者的药物。Nirogacestat结构（二氢溴酸盐）图片来源：FDA批准说明书【公司】Spring Works Therapeutics 【具体适应症】Nirogacestat适用于需要全身治疗的进行性硬纤维瘤成年患者。【作用机制】Nirogacestat是一种γ分泌酶抑制剂，可阻止Notch的蛋白水解激活受体。当失调时，Notch可以激活促进肿瘤生长的途径。【剂型规格】片剂，50mg 【用法用量】建议剂量为150mg，每日两次口服，直到疾病进展或不可接受的毒性。【国内外注册】2023-11-27美国批准；暂未检索其他国家获批上市记录；中国暂无原研和仿制注册/临床进展。 1.2 核心临床情况 Nirogacestat获得FDA批准的主要依据是III期的DeFi (NCT03785964)试验积极结果，该药不仅达到了改善无进展生存期 (PFS) 的主要终点，在次要终点客观缓解率(ORR)和患者报告的结局（PROs）方面也显示出统计学意义和临床意义的改善。研究简介：DeFi试验，一个国际、多中心、在142名患有硬纤维瘤不适合手术的成年患者中进行的随机 (1:1)、双盲、安慰剂对照试验。入组及给药方案：患者被随机接受口服150 mg Nirogacestat或安慰剂，每天两次，直到疾病进展或不可接受的毒性。研究终点：主要终点是PFS；次要终点包括ORR、PROs等。研究结果：有效性方面，Nirogacestat达到了PFS的主要终点，表明与安慰剂相比具有统计显著性改善，疾病进展风险降低了71%。根据RECISTv1.1确认的ORR，治疗组为41%，而安慰剂组为8%；治疗组的完全缓解率为7%，安慰剂组为0%。Nirogacestat主要疗效结果图片来源：FDA批准说明书安全性方面，nirogacestat耐受性良好，安全性可控。任何级别的不良反应（AEs）在治疗组和安慰剂组安全人群中的发生率为69%对72%。治疗组常见的任何级别不良事件包括腹泻（84%）、恶心（54%）、疲劳（51%）和低磷血症（42%）；安慰剂组中常见的任何级别不良事件包括恶心（39%）、疲劳（36%）、腹泻（35%）和呕吐（19%）。 1.3 核心专利情况美国橙皮书收录了该产品的12项专利，涉及化合物/晶型、组合物/制剂及用途等技术领域。Nirogacestat专利情况图片来源：美国OB 注：DS代表该产品的专利，一般包括化合物、晶型/盐；DP代表该产品的组合物/制剂专利；U代表该产品的适应症用途。进一步查看，该产品核心化合物/晶型专利如下：Nirogacestat中美核心专利情况参考来源：OB、欧专局、中国专利局作为最核心及壁垒最高的的化合物专利，最迟于2025年8月18日到期，相关企业可参考关注。 1.4 硬纤维瘤可关注新药硬纤维瘤是一种难以治愈的具有局部侵袭性的软组织肿瘤，可导致严重的发病率。具体来说，硬纤维瘤（侵袭性纤维瘤病、韧带样纤维瘤病、纤维瘤病）是一种源于成纤维细胞的软组织肿瘤，以浸润性生长为主要特征，具有高度复发倾向而无转移行为。疾病主要特点如下：（1）罕见：5-6例/100,0000人/年；（2）好发年龄：30-40岁；（3）发病部位：腹壁、腹腔内、腹外；（4）肿瘤本身病程差异较大；（5）近年来整体治疗方式变化较大。硬纤维瘤目前的治疗主要包括随诊观察、手术切除、放疗/化疗治疗以及靶向药物治疗。靶向药物作为近年来的新兴治疗手段，在硬纤维瘤的治疗中也取得了一定的疗效。硬纤维瘤在研新药情况参考来源：美国临床试验登记网、公开平台等；图形自制 BMS-986115是由百时美施贵宝研发的一种小分子药物，是一种γ-分泌酶抑制剂。目前该药物最高研发阶段为临床三期，用于治疗硬纤维瘤。此前，该药获FDA授予快速通道认定，用于治疗进展性硬纤维瘤。 Endoxifen是由Jina Pharmaceuticals Inc研发的一种小分子药物，是一种ERs调节剂。目前该药物最高研发阶段为临床三期，用于治疗躁狂症。该药物的硬纤维瘤正在开展I期试验。 Tegatrabetan是由艾尔建研发的一种小分子药物，是一种Wnt信号途径抑制剂和CTNNB1抑制剂。目前该药物最高研发阶段为临床二期，用于治疗肝细胞癌；I期包括硬纤维瘤、实体瘤、非霍奇金淋巴瘤、肝胚细胞瘤、骨肉瘤、黑色素瘤、结直肠癌、卵巢上皮癌、神经母细胞瘤、肾母细胞瘤、胰腺癌、胰腺导管癌、尤因肉瘤和子宫内膜癌。 1.5 γ分泌酶抑制剂后继者 Notch信号通路在生物体的早期发育中程序性地操控细胞的命运和组织的分化。γ分泌酶抑制剂，可阻断Notch受体的蛋白水解激活。当失调时，Notch可以激活有助于肿瘤生长的通路。随着γ分泌酶结构的解析和在体内功能的研究进展，其作为癌症和阿尔兹海默症的潜在治疗靶点吸引了跨国制药巨头的目光，有多个γ分泌酶抑制剂进入了临床阶段。 BMS-986115与Nirogacestat同机制同适应症，亦是一种γ-分泌酶抑制剂，用于治疗硬纤维瘤。 Osugacestat是由百时美施贵宝和葛兰素史克研发的一种小分子γ-分泌酶抑制剂，目前该药物最高研发阶段为临床二期，用于治疗三阴性乳腺癌和腺样囊性癌。 BMS-932481是由百时美施贵宝研发的一种一种小分子γ-分泌酶抑制剂。目前该药物最高研发阶段为临床一期，用于治疗阿尔茨海默病。γ分泌酶抑制剂在研新药情况参考来源：美国临床试验登记网、公开平台等；图形自制 Nirogacestat，作为首个获批上市且目前唯一的硬纤维瘤药物，目前又被纳入重磅NCCN指南1类推荐，为硬纤维瘤患者带来新的治疗希望。无论是治疗同领域还是机制药物，Nirogacestat的进度都遥遥领先同类药物，期待该药后续市场表现和解决未满足的临床需求。作者简介：药丸，中国药科大学硕士毕业，具有法律及药学教育背景，拥有法律资格证和专利代理师资格证，致力研究药学和专利，做一颗有价值的药丸。参考资源： 1-NCCN. Clinical Practice Guidelines in Oncology. Soft tissue sarcoma, version 3.2023. 2024-01-12访问；https://www.nccn.org/patients/guidelines/content/PDF/sarcoma-patient.pdf 2-https://www.onclive.com/view/nccn-adds-nirogacestat-to-guidelines-for-patients-with-soft-tissue-sarcoma 3-Gounder M, Ratan R, Alcindor T, et al. Nirogacestat, a γ-secretase inhibitor for desmoid tumors. N Engl J Med. 2023;388(10):898-912. doi:10.1056/NEJMoa2210140 4-硬纤维瘤诊疗的国际专家共识及其解读 5-γ-分泌酶小分子抑制剂和调节剂的作用机制研究 6-Nirogacestat获批说明书 7-Nirogacestat美国OB智药研习社2月课程预告来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

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药物(靶点)	适应症	全球最高研发状态

非那雄胺/米诺地尔 ( 5α-reductase x Potassium channel x VGKCs )	脱发更多	批准上市
内昔芬 ( ER x PKC )	躁狂更多	临床3期
JIN-2016	肿瘤更多	无进展
JIN-2017	肿瘤更多	无进展