A Phase 1b Dose Escalation Trial of NC-6300 (Nanoparticle Epirubicin) in Patients with Advanced Solid Tumors or Advanced, Metastatic, or Unresectable Soft-tissue Sarcoma

Chawla Sant P.; Goel Sanjay; Chow Warren; Braiteh Fadi; Singh Arun S.; Olson Juneko E. Grilley; Osada Atsushi; Bobe Iulian; Riedel Richard F.

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A Phase 1b Dose Escalation Trial of NC-6300 (Nanoparticle Epirubicin) in Patients with Advanced Solid Tumors or Advanced, Metastatic, or Unresectable Soft-tissue Sarcoma

机译：NC-6300（纳米粒子表皮素）的1B期剂量升级试验，患者晚期实体肿瘤或先进，转移或不可切种的软组织肉瘤患者

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Purpose: NC-6300 is a novel nanoparticle formulation of epirubicin that has a pH-sensitive linker conjugated to epirubicin. It exhibits selective tumor accumulation owing to enhanced permeability and retention effect. We conducted a phase 1b trial to determine MTD and recommended phase II dose (RP2D) of NC-6300 monotherapy in advanced, metastatic, or unresectable solid tumors, including soft-tissue sarcomas.

机译：目的：NC-6300是表皮蛋白的新型纳米粒子制剂，其具有与表腹酸缀合的pH敏感的接头。由于增强的渗透性和保留效应，它表现出选择性肿瘤积累。我们进行了一期1B试验，以确定高级，转移性或不可切种的固体肿瘤，包括软组织肉瘤的NC-6300单药治疗的MTD和推荐的II型剂量（RP2D）。

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来源
《Clinical cancer research: an official journal of the American Association for Cancer Research》 |2020年第16期|共8页
作者
Chawla Sant P.; Goel Sanjay; Chow Warren; Braiteh Fadi; Singh Arun S.; Olson Juneko E. Grilley; Osada Atsushi; Bobe Iulian; Riedel Richard F.;
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作者单位

Canc Ctr Southern Calif Sarcoma Oncol Ctr Santa Monica CA USA;

Montefiore Med Ctr 111 E 210th St Bronx NY 10467 USA;

City Hope Natl Med Ctr Duarte CA USA;

Comprehens Canc Ctr Nevada Las Vegas NV USA;

Univ Calif Los Angeles Med Ctr Los Angeles CA USA;

UNC Lineberger Comprehens Canc Ctr Chapel Hill NC USA;

NanoCarrier Co Ltd Tokyo Japan;

NanoCarrier Co Ltd Tokyo Japan;

Duke Univ Med Ctr Duke Canc Inst Durham NC USA;

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原文格式 PDF
正文语种 eng
中图分类肿瘤学;
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1. A Phase 1b Dose Escalation Trial of NC-6300 (Nanoparticle Epirubicin) in Patients with Advanced Solid Tumors or Advanced, Metastatic, or Unresectable Soft-tissue Sarcoma [J] . Chawla Sant P., Goel Sanjay, Chow Warren, Clinical cancer research: an official journal of the American Association for Cancer Research . 2020,第16期

机译：NC-6300（纳米粒子表皮素）的1B期剂量升级试验，患者晚期实体肿瘤或先进，转移或不可切种的软组织肉瘤患者
2. A first-in-human Phase 1 study of epirubicin-conjugated polymer micelles (K-912/NC-6300) in patients with advanced or recurrent solid tumors [J] . Mukai Hirofumi, Kogawa Takahiro, Matsubara Nobuaki, Investigational new drugs. . 2017,第3期

机译：先进或复发性实体肿瘤患者的EPIRUBICIN蛋白 - 共轭聚合物胶束（K-912 / NC-6300）的第一单相1研究
3. 367?A phase 1/1b dose-escalation study of intravenously administered SB 11285 alone and in combination with atezolizumab in patients with advanced solid tumors [J] . Jason Luke, Filip Janku, Anthony Olszanski, Journal for ImmunoTherapy of Cancer . 2020,第Suppla3期

机译：367？单独静脉内施用的Sb 11285和与atezolizumab在高级实体肿瘤患者中的相1/1b剂量升级研究
4. Phase I Clinical Trial with Her-2 B-Cell Chimeric and MultiEpitope Based Peptide Vaccines in Patients with Metastatic and/or Recurrent Solid Tumors [C] . Pravin T.P. Kaumaya, Kevin Chu Foy, Joan Garrett American Peptide Symposium . 2009

机译：患者临床试验与患有转移和/或复发性固体瘤的患者的HER-2 B细胞嵌合和多型肽疫苗
5. A phase I study of vincristine, escalating doses of irinotecan, temozolomide and bevacizumab (VIT-B) in pediatric and adolescent patients with recurrent or refractory solid tumors of non-hematopoietic origin [D] . Venkatramani, Rajkumar. 2010

机译：长春新碱，伊非替康，替莫唑胺和贝伐单抗（VIT-B）逐步剂量在患有非造血源性复发或难治性实体瘤的儿童和青少年患者中的I期研究
6. Phase 1/1b dose escalation and expansion study of BEZ235 a dual PI3K/mTOR inhibitor in patients with advanced solid tumors including patients with advanced breast cancer [O] . Jordi Rodon, Alejandro PérezFidalgo, Ian E. Krop, -1

机译：BEZ235（PI3K / mTOR双重抑制剂）在晚期实体瘤患者（包括晚期乳腺癌）中的1 / 1b剂量递增和扩展研究
7. Gemcitabine and docetaxel versus doxorubicin as first-line treatment in previously untreated advanced unresectable or metastatic soft-tissue sarcomas (GeDDiS): a randomised controlled phase 3 trial. [O] . Seddon B., Strauss S.J., Whelan J., 2017

机译：吉西他滨和多西紫杉醇与多柔比星作为先前未治疗的晚期不可切除或转移性软组织肉瘤（GeDDis）的一线治疗：随机对照3期试验。

A Phase 1b Dose Escalation Trial of NC-6300 (Nanoparticle Epirubicin) in Patients with Advanced Solid Tumors or Advanced, Metastatic, or Unresectable Soft-tissue Sarcoma

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