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NIS793 联合标准护理 (SOC) 化疗治疗一线转移性胰腺导管腺癌 (mPDAC) 的疗效和安全性研究 - daNIS-2

2026年4月27日 更新者：Novartis Pharmaceuticals

一项随机、双盲、III 期研究，比较 NIS793 联合吉西他滨和 Nab-紫杉醇与安慰剂联合吉西他滨和 Nab-紫杉醇一线治疗转移性胰腺导管腺癌 (mPDAC) - daNIS-2

本研究的目的是评估 NIS793 联合吉西他滨/白蛋白结合型紫杉醇与吉西他滨/白蛋白结合型紫杉醇和安慰剂联合治疗一线转移性胰腺导管腺癌 (mPDAC) 的疗效和安全性。

本研究旨在探索转化生长因子 β (TGFβ) 联合吉西他滨/白蛋白结合型紫杉醇的阻断是否可以减少 PDAC 中的纤维化、恢复化疗敏感性并最终改善总生存期 (OS) 和其他临床相关结果。

研究概览

地位

完全的

条件

干预/治疗

详细说明

这是一项随机、双盲、多中心、双臂、III 期研究，分为两部分：

  • 安全磨合部分：将进行开放标签安全磨合部分，以确认 NIS793 与吉西他滨和白蛋白结合型紫杉醇联合使用的推荐第 3 阶段剂量 (RP3D)。 每个剂量水平将招募最多约 10 名参与者，以达到至少 6 名可评估的参与者；但是，如果不推荐起始剂量并且测试了较低的剂量水平，则将招募 10 名额外的参与者。 打开随机化部分的决定将基于剂量确认和可用的安全性、相关 PK 以及来自试运行部分的其他相关数据
  • 随机部分：登记的参与者将被随机分配到两个治疗组。

研究治疗将以 28 天的治疗周期进行。 参与者将接受治疗，直到不可接受的毒性、根据 RECIST 1.1 的疾病进展、撤回同意或协议中指定的任何其他治疗中断条件。

研究类型

介入性

注册 (实际的)

511

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
      • Beijing、中国、100730
        • Novartis Investigative Site
      • Beijing、中国、100021
        • Novartis Investigative Site
      • Beijing、中国、100036
        • Novartis Investigative Site
      • Shanghai、中国、200032
        • Novartis Investigative Site
      • Shanghai、中国、200127
        • Novartis Investigative Site
      • Shanghai、中国、200433
        • Novartis Investigative Site
      • Shanghai、中国、200025
        • Novartis Investigative Site
      • Tianjin、中国、300480
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou、Guangdong、中国、510000
        • Novartis Investigative Site
    • Heilongjiang
      • Harbin、Heilongjiang、中国、150081
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing、Jiangsu、中国、210029
        • Novartis Investigative Site
    • Liaoning
      • Dalian、Liaoning、中国、116001
        • Novartis Investigative Site
    • Shandong
      • Jining、Shandong、中国、272000
        • Novartis Investigative Site
    • Shanxi
      • Xian、Shanxi、中国、710061
        • Novartis Investigative Site
    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310022
        • Novartis Investigative Site
  • 以色列
      • Jerusalem、以色列、9112001
        • Novartis Investigative Site
      • Ramat Gan、以色列、5265601
        • Novartis Investigative Site
      • Tel Aviv、以色列、6423906
        • Novartis Investigative Site
  • 俄罗斯
      • Omsk、俄罗斯、644013
        • Novartis Investigative Site
      • Saint Petersburg、俄罗斯、196603
        • Novartis Investigative Site
  • 加拿大
    • Ontario
      • Brampton、Ontario、加拿大、L6R 3J7
        • Novartis Investigative Site
      • Cambridge、Ontario、加拿大、N1R 3G2
        • Novartis Investigative Site
      • Toronto、Ontario、加拿大、M4N 3M5
        • Novartis Investigative Site
  • 匈牙利
      • Budapest、匈牙利、H 1122
        • Novartis Investigative Site
      • Budapest、匈牙利、H-1097
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen、Hajdu Bihar Megye、匈牙利、4032
        • Novartis Investigative Site
  • 台湾
      • Taipei、台湾、10002
        • Novartis Investigative Site
      • Taipei、台湾、11217
        • Novartis Investigative Site
      • Taoyuan、台湾、33305
        • Novartis Investigative Site
  • 土耳其（türkiye）
      • Izmir、土耳其（türkiye）、35100
        • Novartis Investigative Site
    • Kadikoy
      • Istanbul、Kadikoy、土耳其（türkiye）、34722
        • Novartis Investigative Site
    • Sihhiye-Altindag
      • Ankara、Sihhiye-Altindag、土耳其（türkiye）、06230
        • Novartis Investigative Site
    • Yuregir
      • Adana、Yuregir、土耳其（türkiye）、01250
        • Novartis Investigative Site
  • 巴西
    • Federal District
      • Brasília、Federal District、巴西、70200-730
        • Novartis Investigative Site
    • Rio Grande do Sul
      • Ijuí、Rio Grande do Sul、巴西、98700-000
        • Novartis Investigative Site
      • Porto Alegre、Rio Grande do Sul、巴西、90560-032
        • Novartis Investigative Site
    • São Paulo
      • São Paulo、São Paulo、巴西、04014-002
        • Novartis Investigative Site
  • 希腊
      • Thessaloniki、希腊、540 07
        • Novartis Investigative Site
      • Thessaloniki、希腊、570 01
        • Novartis Investigative Site
  • 德国
      • Berlin、德国、13353
        • Novartis Investigative Site
      • Bochum、德国、44791
        • Novartis Investigative Site
      • Essen、德国、45147
        • Novartis Investigative Site
      • Hamburg、德国、20249
        • Novartis Investigative Site
      • Ulm、德国、89081
        • Novartis Investigative Site
    • Hesse
      • Frankfurt am Main、Hesse、德国、60488
        • Novartis Investigative Site
    • Saxony-Anhalt
      • Halle、Saxony-Anhalt、德国、06120
        • Novartis Investigative Site
  • 意大利
    • FI
      • Florence、FI、意大利、50134
        • Novartis Investigative Site
    • MI
      • Milan、MI、意大利、20133
        • Novartis Investigative Site
      • Milan、MI、意大利、20162
        • Novartis Investigative Site
    • VR
      • Verona、VR、意大利、37134
        • Novartis Investigative Site
  • 挪威
      • Oslo、挪威、NO-0407
        • Novartis Investigative Site
    • Oslo
      • Nordbyhagen、Oslo、挪威、1478
        • Novartis Investigative Site
  • 捷克语
      • Brno、捷克语、656 53
        • Novartis Investigative Site
      • Hradec Králové、捷克语、500 05
        • Novartis Investigative Site
      • Nový Jičín、捷克语、741 01
        • Novartis Investigative Site
      • Prague、捷克语、140 59
        • Novartis Investigative Site
  • 斯洛伐克
      • Banská Bystrica、斯洛伐克、975 17
        • Novartis Investigative Site
      • Bratislava、斯洛伐克、83310
        • Novartis Investigative Site
      • Košice、斯洛伐克、041 91
        • Novartis Investigative Site
  • 新加坡
      • Singapore、新加坡、168583
        • Novartis Investigative Site
  • 日本
    • Aichi-ken
      • Nagoya、Aichi-ken、日本、4648681
        • Novartis Investigative Site
    • Chiba
      • Kashiwa、Chiba、日本、277-8577
        • Novartis Investigative Site
    • Kanagawa
      • Yokohama、Kanagawa、日本、241-8515
        • Novartis Investigative Site
    • Osaka
      • Osaka、Osaka、日本、5418567
        • Novartis Investigative Site
    • Tokyo
      • Chuo Ku、Tokyo、日本、1040045
        • Novartis Investigative Site
      • Koto Ku、Tokyo、日本、1358550
        • Novartis Investigative Site
  • 比利时
      • Bonheiden、比利时、2820
        • Novartis Investigative Site
      • Brussels、比利时、1200
        • Novartis Investigative Site
      • Edegem、比利时、2650
        • Novartis Investigative Site
      • Leuven、比利时、3000
        • Novartis Investigative Site
  • 法国
      • Avignon、法国、84082
        • Novartis Investigative Site
      • Besançon、法国、25030
        • Novartis Investigative Site
      • Créteil、法国、94010
        • Novartis Investigative Site
      • Lyon 08、法国、69373
        • Novartis Investigative Site
      • Marseille、法国、13273
        • Novartis Investigative Site
      • Montpellier、法国、34295
        • Novartis Investigative Site
      • Nantes、法国、44093
        • Novartis Investigative Site
      • Paris、法国、75015
        • Novartis Investigative Site
    • Alpes Maritimes
      • Nice、Alpes Maritimes、法国、06189
        • Novartis Investigative Site
  • 澳大利亚
    • South Australia
      • Adelaide、South Australia、澳大利亚、5000
        • Novartis Investigative Site
    • Western Australia
      • Perth、Western Australia、澳大利亚、6009
        • Novartis Investigative Site
  • 瑞典
      • Malmö、瑞典、SE-205 02
        • Novartis Investigative Site
      • Umeå、瑞典、901 85
        • Novartis Investigative Site
  • 瑞士
      • Bellinzona、瑞士、6500
        • Novartis Investigative Site
      • Geneva、瑞士、1211
        • Novartis Investigative Site
      • Sankt Gallen、瑞士、9007
        • Novartis Investigative Site
  • 美国
    • Arkansas
      • Fayetteville、Arkansas、美国、72703
        • Highlands Oncology Group
    • California
      • Los Angeles、California、美国、90095
        • University of California LA
    • Florida
      • Orlando、Florida、美国、32804
        • AdventHealth
    • Indiana
      • Fort Wayne、Indiana、美国、46815
        • Fort Wayne Medical Oncology Hematology Inc
    • New York
      • New York、New York、美国、10016
        • Nyu Clinical Cancer Center
    • Texas
      • Dallas、Texas、美国、75204
        • US Oncology Research Dallas
      • Houston、Texas、美国、77030
        • Houston Methodist Hospital
    • Utah
      • Salt Lake City、Utah、美国、84112
        • Huntsman Cancer Institute
    • Washington
      • Seattle、Washington、美国、98109
        • Seattle Cancer Care Alliance
  • 芬兰
      • Helsinki、芬兰、00290
        • Novartis Investigative Site
      • Tampere、芬兰、FIN-33521
        • Novartis Investigative Site
  • 英国
      • Cambridge、英国、CB2 0QQ
        • Novartis Investigative Site
      • Liverpool、英国、CH63 4JY
        • Novartis Investigative Site
      • London、英国、EC1A 7BE
        • Novartis Investigative Site
      • Oxford、英国、OX3 7LE
        • Novartis Investigative Site
    • Surrey
      • Sutton、Surrey、英国、SM2 5PT
        • Novartis Investigative Site
  • 荷兰
      • Utrecht、荷兰、3543 AZ
        • Novartis Investigative Site
  • 西班牙
      • Barcelona、西班牙、08035
        • Novartis Investigative Site
      • Madrid、西班牙、28034
        • Novartis Investigative Site
      • Madrid、西班牙、28040
        • Novartis Investigative Site
      • Madrid、西班牙、28009
        • Novartis Investigative Site
    • A Coruna
      • Santiago Compostela、A Coruna、西班牙、15706
        • Novartis Investigative Site
    • Barcelona
      • L'Hospitalet de Llobregat、Barcelona、西班牙、08907
        • Novartis Investigative Site
  • 韩国
      • Seoul、韩国、03080
        • Novartis Investigative Site
      • Seoul、韩国、05505
        • Novartis Investigative Site
      • Seoul、韩国、06591
        • Novartis Investigative Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 适用于安全磨合和随机零件

    • 年龄≥18 岁且经组织学或细胞学证实（根据当地评估和当地指南）的 mPDAC 参与者有资格在一线环境中接受治疗，并且不适合进行潜在的治愈性手术
    • 根据 RECIST 1.1，通过计算机断层扫描 (CT) 和/或磁共振成像 (MRI) 评估的至少一个可测量病变的存在
    • 东部合作肿瘤组 (ECOG) 表现状态 0-1
    • 足够的器官功能（由中心实验室评估是否合格）
    • 除脱发外，参与者在筛选时必须已从先前抗癌疗法的治疗相关毒性中恢复至 ≤ 1 级 (CTCAE v 5.0)。

主要排除标准：

  • 适用于安全磨合和随机零件

    • 转移性 PDAC 的既往全身抗癌治疗
    • 胰腺神经内分泌、腺泡或胰岛肿瘤
    • 具有已知微卫星不稳定性高 (MSI-H) 或错配修复缺陷型胰腺癌状态的参与者（如果状态尚不可用，则筛选时不需要进行测试）。
    • 参与者尚未从研究治疗开始前进行的大手术中恢复，或在研究治疗开始前 4 周内进行过大手术。
    • 在研究治疗开始前 ≤ 4 周进行放射治疗或脑放疗（允许在研究治疗开始前 > 2 周对骨病变进行姑息性放疗）。
    • 心脏功能受损或有临床意义的心血管疾病
    • 在研究治疗开始前 ≤ 2 周内使用造血生长因子或输血支持。
    • 参与者的病症被认为具有临床显着胃肠道出血的高风险或任何其他与显着出血相关的病症或病史。
    • 严重的不愈合伤口。
    • 孕妇或哺乳期妇女
    • 有生育能力的女性，除非愿意在治疗期间和停止研究治疗后按照指示使用高效避孕方法
    • 预先存在的周围神经病变 > 1 级 (CTCAE v5.0)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Safety run-in part: NIS793 plus (Gemcitabine and Nab-paclitaxel)

Participants received a combination of NIS793, Gemcitabine and Nab-paclitaxel :

  • NIS793 at 2100 mg (Days 1 and 15)
  • Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
  • Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)

Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.
药品：NIS793
溶液输注浓缩物（小瓶中的液体）
药品：Nab-紫杉醇
根据当地批准的配方
药品：吉西他滨
根据当地批准的配方
实验性的：Randomized part (Arm A): NIS793 plus (Gemcitabine and Nab-paclitaxel)

Participants received a combination of NIS793, gemcitabine and nab-paclitaxel:

  • NIS793 at 2100 mg (Days 1 and 15) assuming this was the confirmed RP3D in the safety run-in part or NIS793 at 2100 mg on Day 1 if dose level -1 was the confirmed RP3D in the safety run-in
  • Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
  • Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)

Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.
药品：NIS793
溶液输注浓缩物（小瓶中的液体）
药品：Nab-紫杉醇
根据当地批准的配方
药品：吉西他滨
根据当地批准的配方
药品：安慰剂
用于输注的 5% 葡萄糖水溶液 (D5W)
安慰剂比较：Randomized part (Arm B): Placebo plus (Gemcitabine and Nab-paclitaxel)

Participants received a combination of placebo, gemcitabine and nab-paclitaxel:

  • Placebo for NIS793 (Days 1 and 15)
  • Gemcitabine at 1000 mg/m² (Days 1, 8 and 15)
  • Nab-paclitaxel at 125 mg/m² (Days 1, 8 and 15)

Note: As of 7-Jul-2023, treatment with NIS793/placebo was stopped. Study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.
药品：Nab-紫杉醇
根据当地批准的配方
药品：吉西他滨
根据当地批准的配方
药品：安慰剂
用于输注的 5% 葡萄糖水溶液 (D5W)

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Safety run-in Part: Percentage of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle (4 Weeks) of Treatment.
大体时间：Up to 4 weeks
A dose-limiting toxicity (DLT) was defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first cycle (i.e., 28 days or 4 weeks) of the treatment with NIS793 in combination with gemcitabine/nab-paclitaxel. The National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 5 was used for all grading.
Up to 4 weeks
Randomized Part: Overall Survival (OS)
大体时间：From randomization up to death, assessed up to approximately 34 months
Overall Survival (OS) was defined as the time from date of randomization/start of treatment to date of death due to any cause. If a patient was not known to have died, survival was censored at the date of last known date patient alive.
From randomization up to death, assessed up to approximately 34 months

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants With Adverse Events (AEs)
大体时间：Up to approximately 32 months

An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. Therefore, an AE may or may not be temporally or causally associated with the use of a medicinal (investigational) product.

Treatment emergent Adverse Event (TEAEs) in this study are events that started after the first dose of study treatment and until 30 days after last dose of SOC chemotherapies and up to 90 days after NIS793, whichever is later.
Up to approximately 32 months
Percentage of Participants With Dose Interruptions and Dose Reductions of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
大体时间：Up to approximately 32 months

No dose reductions were allowed for NIS793 in the Randomized part and beyond the first 28 days period of the Safety Run-in part. Increasing the dosing interval from every 2 weeks (Q2W) to every 2 weeks (Q4W) was allowed.

Dose interruption for NIS793 was permitted if adverse drug reaction was suspected to be related to NIS793. If NIS793 was interrupted or delayed for > 8 weeks due to toxicity that was suspected to be related to treatment, study treatment was permanently discontinued.
Up to approximately 32 months
Dose Intensity of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
大体时间：Up to approximately 32 months
Dose intensity was computed as the ratio of actual cumulative dose received and actual duration of exposure.
Up to approximately 32 months
Progression-Free Survival (PFS)
大体时间：From enrollment (run-in part) or randomization (randomized part) up to disease progression or death, assessed up to approximately 34 months
Progression-Free Survival (PFS) was defined as the time from the enrollment (run-in part) or randomization (randomized part) to the date of the first documented disease progression based on local investigator assessment as per RECIST 1.1 or date of death due to any cause, whichever occurs first. PFS was censored if no PFS event was observed before the analysis cut-off date. The censoring date was the date of the last adequate tumor assessment prior to the analysis cut-off.
From enrollment (run-in part) or randomization (randomized part) up to disease progression or death, assessed up to approximately 34 months
Overall Response Rate (ORR)
大体时间：Up to approximately 34 months
Overall Response Rate (ORR) was defined as the proportion of participants with a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) as per local review. ORR was evaluated according to RECIST 1.1. The BOR was determined from response assessments undertaken while on treatment.
Up to approximately 34 months
Disease Control Rate (DCR)
大体时间：Up to approximately 34 months
Disease Control Rate (DCR) was defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), or Stable Disease (SD) or Non-CR/Non-progressive disease as per local review. DCR was evaluated according to RECIST 1.1.
Up to approximately 34 months
Duration of Response (DOR)
大体时间：Up to approximately 34 months
Duration of Response (DOR) was defined as the duration of time between the date of first documented response (CR or PR) and the date of first documented progression or death due to any cause.
Up to approximately 34 months
Time to Response (TTR)
大体时间：From enrollment (run-in part) or randomization (randomized part) up to first documented response, assessed up to approximately 34 months
Time to Response (TTR) was defined as the duration of time between the date of enrollment (run-in part) or randomization (randomized part) and the date of first documented response of either CR or PR as per local review, which was subsequently confirmed. TTR was evaluated according to RECIST 1.1. Participants without a confirmed CR or PR were censored at the time of PFS event (i.e., disease progression or death due to any cause) for participants with a PFS event (i.e., disease progression or death due to any cause), or at the date of the last adequate tumor assessment for participants without a PFS event.
From enrollment (run-in part) or randomization (randomized part) up to first documented response, assessed up to approximately 34 months
Safety run-in Part: Trough Concentration (Ctrough) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
大体时间：Cycles 1 and 3 Day 15 (0 hour (pre-dose)), Cycles 2, 4, 6 and 12 Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Ctrough was listed and summarized using descriptive statistics.
Cycles 1 and 3 Day 15 (0 hour (pre-dose)), Cycles 2, 4, 6 and 12 Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
Safety run-in Part: Maximum Concentration (Cmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
大体时间：Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Cmax was listed and summarized using descriptive statistics.
Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Safety run-in Part: Time to Reach Maximum Concentration (Tmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
大体时间：Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Venous whole blood samples were collected for activity-based pharmacokinetics characterization. Tmax was listed and summarized using descriptive statistics.
Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Randomized Part (Chinese Participants With Intensive PK Sampling): Trough Concentration (Ctrough) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
大体时间：Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15, Cycle 4 Day 1 and Cycle 6 Day 1: 0 hour (pre-dose). 1 cycle = 28 days.
In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants. Venous whole blood samples were collected for activity-based pharmacokinetics characterization and Ctrough was summarized using descriptive statistics.
Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15, Cycle 4 Day 1 and Cycle 6 Day 1: 0 hour (pre-dose). 1 cycle = 28 days.
Randomized Part (Chinese Participants With Intensive PK Sampling): Maximum Concentration (Cmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
大体时间：Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants. Venous whole blood samples were collected for activity-based pharmacokinetics characterization and Cmax was summarized using descriptive statistics.
Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Randomized Part (Chinese Participants With Intensive PK Sampling): Time to Reach Maximum Concentration (Tmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
大体时间：Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants. Venous whole blood samples were collected for activity-based pharmacokinetics characterization and Tmax was summarized using descriptive statistics.
Cycles 1 and 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Randomized Part (Chinese Participants With Intensive PK Sampling): Area Under the Curve From Time Zero to the Last Measurable Concentration Sampling Time (AUClast) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
大体时间：Cycles 1 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants. Venous whole blood samples were collected for activity-based pharmacokinetics characterization and AUClast was summarized using descriptive statistics.
Cycles 1 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Randomized Part (Chinese Participants With Intensive PK Sampling): Area Under the Curve Calculated to the End of a Dosing Interval (Tau) at Steady-state (AUCtau) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
大体时间：Cycles 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
In the randomized part, participants enrolled for treatment in China were assigned to more intensive PK sampling (taken into account the ability of clinical sites to comply with the instructions in the laboratory manual concerning the preparation of serum samples) to assess PK of NIS793 in Chinese participants. Venous whole blood samples were collected and AUCtau was summarized using descriptive statistics.
Cycles 3 Day 1: 0 hour (pre-dose) and 1 hour. 1 cycle = 28 days.
Randomized Part (Participants Without Intensive PK Sampling): Trough Concentration (Ctrough) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
大体时间：Cycles 2, 3, 4, 6 and 12 Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
For participants without intensive PK sampling, venous whole blood samples were collected for activity-based pharmacokinetics characterization. Ctrough was listed and summarized using descriptive statistics.
Cycles 2, 3, 4, 6 and 12 Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
Randomized Part (Participants Without Intensive PK Sampling): Maximum Concentration (Cmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
大体时间：Cycles 1 and 3: Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
For Chinese participants without intensive PK sampling schedule and global participants in the randomized part, for which only sparse PK samples were collected for activity-based pharmacokinetics characterization, Cmax was listed and summarized using descriptive statistics.
Cycles 1 and 3: Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
Randomized Part (Participants Without Intensive PK Sampling): Time to Reach Maximum Concentration (Tmax) of NIS793 in Combination With Gemcitabine and Nab-paclitaxel
大体时间：Cycles 1 and 3: Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
For Chinese participants without intensive PK sampling schedule and global participants in the randomized part, for which only sparse PK samples were collected for activity-based pharmacokinetics characterization, Tmax was listed and summarized using descriptive statistics.
Cycles 1 and 3: Day 1 (0 hour (pre-dose)). 1 cycle = 28 days.
Randomized Part: Anti-drug Antibodies (ADA) Against NIS793 Prevalence at Baseline
大体时间：Baseline
Anti-drug antibodies (ADA) against NIS793 prevalence at baseline refers to the proportion of subjects who have developed antibodies against the drug NIS793 before starting treatment. This is calculated by dividing the number of subjects with ADA-positive samples at baseline by the total number of subjects whose baseline samples were tested for ADA.
Baseline
Randomized Part: Anti-drug Antibodies (ADA) Against NIS793 Incidence on Treatment
大体时间：From date of first study drug intake up to approximately 34 months

Anti-drug antibodies (ADA) against NIS793 incidence on treatment refers to the proportion of participants who developed antibodies against the drug NIS793 during the treatment period. This can be categorized into two types:

  1. Treatment-induced ADA positive: Participants who were ADA-negative at baseline but became ADA-positive after starting the treatment.
  2. Treatment-boosted ADA positive: Participants who were ADA-positive at baseline and showed a significant increase in ADA titer during the treatment.
From date of first study drug intake up to approximately 34 months

合作者和调查者

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赞助

Novartis Pharmaceuticals

调查人员

  • 研究主任：Novartis Pharmaceuticals、Novartis Pharmaceuticals

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年9月30日

初级完成 (实际的)

2024年8月13日

研究完成 (实际的)

2024年8月13日

研究注册日期

首次提交

2021年6月21日

首先提交符合 QC 标准的

2021年6月21日

首次发布 (实际的)

2021年6月23日

研究记录更新

最后更新发布 (实际的)

2026年5月19日

上次提交的符合 QC 标准的更新

2026年4月27日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CNIS793B12301
  • 2021-000591-10 (EudraCT编号)

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