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phase i study of chimeric anti-CD20 monoclonal antibody in Chinese patients with CD20-positive non-Hodgkin＇s lymphoma

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Chinese Journal of Cancer Research 2016年第2期28卷 197-208页

作者： Lin Gui Xiaohong Han Xiaohui He Yuanyuan Song Jiarui Yao Jianliang Yang Peng Liu Yan Qin Shuxiang Zhang Weijing Zhang Wenlin Gai Liangzhi Xie Yuankai Shi Department of Medical Oncology Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs National Cancer Center/ Cancer Hospital Chinese Academy of Medical Sciences & Peking Union Medical College Beijing 100021 China Department of Lymphoma the 307th Hospital of Chinese People's Liberation Army & the Affiliated Hospital of Military Medical Sciences Beijing 100071 China Cell Culture Research and Development Center Chinese Academy of Medical Sciences & Peking Union Medical College Beijing 100176 China

Objective： This study was designed to determine the safety, pharmacokinetics and biologic effects of a humanmouse chimeric anti-CD20 monoclonal antibody （SCT400） in Chinese padents with CD20-positive B-cell non- Hodgkin＇s lymphoma （CD20 B-cell NHL）. SCT400 has an identical amino acid sequence as rituximab, with the exception of one amino acid in the CH1 domain of the heavy chain, which is common in Asians. Methods： Fifteen patients with CD20＋ B-cell NHL received dose-escalating SCT400 infusions （250 mg/m2： n=3; 375 mg/m2： n=9; 500 mg/m2： n=3） once weekly for 4 consecutive weeks with a 24-week follow-up period. The data of all patients were collected for pharmacoklnetics and pharmacodynamics analyses. Results： No dose-limiting toxicities were observed. Most drug-related adverse events were grade 1 or 2. Two patients had grade 3 or 4 ncutropenia. Under premedication, the drug-related infusion reaction was mild. A rapid, profound and durable depletion of circulating B cells was observed in all dose groups without significant effects on T cell count, natural killer （NK） cell count or immunoglobulin levels. No patient developed anti- SCT400 antibodies during the course of the study. SCT400 serum half-life （Tin）, maximum concentration （Cmax and area under the curve （AUC） generally increased between the first and fourth infusions （P〈0.05）. At the 375 mg/m2 dose, the T1/2 was 122.5±46.7 h vs. 197.0,75.0 11, respectively, and the Cmax was 200.6±20.2 pg/mL vs. 339.1±71.0 ng/mL, respectively. From 250 mg/m2 to 500 mg/m2, the Cmax and AUC increased significantly in a dose-dependent manner （P〈0.05）. Patients with a high tumor burden had markedly lower serum SCT400 concenmations compared with those without or with a low tumor burden. Of the 9 assessable patients, 1 achieved complete response and 2 achieved partial responses. Conclusions; SCT400 is well-tolerated and has encouraging preliminary efficacy in Chinese patients with CD20＋ B-cell NHL.

关键词： Chimeric anti-CD20 monodonal antibody non-Hodgldn's lymphoma phase i study

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A phase i study of toripalimab, an anti-PD-1 antibody, in patients with refractory malignant solid tumors

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Cancer Communications 2020年第8期40卷 345-354页

作者： Xiao-LiWei Chao Ren Feng-HuaWang Yang Zhang Hong-Yun Zhao Ben-Yan Zou Zhi-Qiang Wang Miao-Zhen Qiu Dong-Sheng Zhang Hui-Yan Luo Feng Wang Sheng Yao Rui-Hua Xu Department of Medical Oncology State Key Laboratory of Oncology in South ChinaCollaborative Innovation Center for Cancer MedicineSun Yat-sen University Cancer CenterGuangzhouGuangdong 510060P.R.China Shanghai Junshi Biosciences Company Limited Shanghai 201203 P.R.China Precision Diagnosis and Treatment for Gastrointestinal Cancer Chinese Academy of Medical SciencesGuangzhouGuangdong 510060P.R.China

Background:Several programmed cell death ligand 1(PD-L1)/programmed cell death protein 1(PD-1)antibodies have been approved for cancer *** pharmacokinetic and pharmacodynamic characteristics have been reported mainly in western countries,but related data in Chinese patients are *** study was conducted to investigate the safety,efficacy,pharmacokinetics,and pharmacodynamics of an anti-PD-1 antibody,toripalimab,in Chinese ***:A single-center phase i study was conducted in Sun Yat-sen University Cancer *** patients were adults with histologically confirmed,treatment-refractory,advanced,solitary malignant *** was intravenously infused every 2 weeks in dose-escalating cohorts at 0.3mg/kg,1 mg/kg,3 mg/kg,10 mg/kg,and 240 *** study followed standard 3+3 ***:Between 15th March 2016 and 27th September 2016,25 patients were enrolled,of whom 3(12.0%),7(28.0%),6(24.0%),6(24.0%),3(12.0%)received 0.3 mg/kg,1 mg/kg,3 mg/kg,10 mg/kg,and 240 mg toripalimab,*** a median follow-up time of 5.0 months(range:1.5-19.8 months),we observed that the commonest treatment-related adverse events(TRAEs)were fatigue(64.0%)and rash(24.0%).No grade 3 or higher TRAEs were *** dose-limiting toxicity,treatment-related serious adverse events(SAEs),or treatment-related death *** response ratewas 12.5%.The half-life of toripalimabwas 150-222 h after a single dose *** patients,including those from the 0.3 mg/kg group,maintained complete PD-1 receptor occupancy(>80%)on activated T cells since receiving the first dose of ***:Toripalimab is a promising anti-PD-1 antibody,which was well tolerated and demonstrated anti-tumor activity in treatment-refractory advanced solitary malignant *** exploration in various tumors and combination therapies is warranted.

关键词： anti-PD-1 antibody toripalimab phase i study safety efficacy pharmacokinetics pharmacodynamics solid tumor

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phase i Dose Escalation study with the Lewis Y Carbohydrate Specific Humanized Antibody iGN311

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Journal of Cancer Therapy 2011年第5期2卷 760-771页

作者： Daniel Oruzio Gunter Waxenecker Christoph Aulmann Bruno Markl Theodor Wagner Geert Mudde Manfred Schuster Norbert Eller Andrea Mayer Stefan Stranner Gottfried Himmler Hans Loibner Günter Schlimok Ralf Kircheis Andreas Nechansky Zentralklinikum AugsburgGermany igeneon ViennaAustria AGES Pharmed ViennaAustria S-TARget ViennaAustria Apeiron ViennaAustria CDMS ViennaAustria immatics TubingenGermany f-Star ViennaAustria ViroLogik ErlangenGermany Meridian Biopharmaceuticals ViennaAustria.

Purpose: investigation of safety, tolerability, pharmacokinetics, and anti-tumor activity of the Lewis Y-specific, fully humanized monoclonal antibody (mAb) iGN311 in patients with Lewis Y positive tumors in a phase i clinical trial. Experimental Design: Twelve patients (pts) were enrolled in an open-label, uncontrolled, dose escalating phase i study. Three pts received 50 mg, three pts 100 mg and six pts 200 mg iGN311 by i.v. infusion on days 1 and 15. Blood samples were taken immediately before infusion, and 0.5, 4, 8, 24 hours post infusion, as well as on days 3, 5 and 8 after the first and second infusion, respectively, and day 29. A final visit was scheduled for day 43. Results: No drug related adverse events were observed in the 50 mg and 100 mg dose groups. Three out of six patients in the 200 mg dose group showed drug related adverse reactions with nausea, vomiting and hypotension in one patient (NCi CTC grade 3) being the dose limiting toxicities. t1/2 of iGN311 was ~20 days after second infusion of iGN311. Sera of patients receiving iGN311 were capable of lysing Lewis Y positive tumor cells in vitro by both, complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC). Circulating tumor cells found in the peripheral blood in two out of twelve pts prior to treatment were reduced after treatment to below the quantification limit of the detection method. None of the patients showed an increase in the number of disseminated tumor cells during treatment period. Conclusions: The good safety and PK profile, the biological activity regarding CDC and ADCC mediated tumor cell lysis, and the elimination of circulating tumor cells warrant further clinical investigation of iGN311.

关键词： Passive immunotherapy Therapeutic Monoclonal Antibody Disseminated Tumor Cells phase i study Lewis Y Carbohydrate HAHA (Human Anti-Human Antibodies)

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Weekly gemcitabine as a radiosensitiser for the treatment of brain metastases in patients with non-small cell lung cancer:phase Ⅰ trial

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Chinese Medical Journal 2007年第6期120卷 458-462页

作者： HUANG Yu-juan WU Yi-long XiE Song-xi YANG Jing-ji HUANG Yi-sheng LiAO Ri-qiang Department of Lung Cancer Cancer Center Guangdong Provincial People＇s Hospital Guangzhou 510080 China

Background Conventional treatment for non-small cell lung cancer （NSCLC） brain metastases （BM） is whole-brain radiotherapy （WBRT）. The efficacy is limited. it might be increased by a potent radiosensitizer such as gemcitabine, which is believed to cross the disrupted blood-brain barrier. The primary objective of this study was to determine the maximum tolerated dose （MTD） of weekly gemcitabine given concurrently with WBRT. Methods Patients with BM from NSCLC were included. The dose of WBRT was 3750 cGy （total 15 times, 3 weeks）. Gemcitabine was given concurrently with WBRT on days 1, 8 and 15. The starting dose was 400 mg/m^2, escalated by 100 mg/m^2 increments. At least three patients were included per level. Dose limiting toxicity （DLT） was defined as grade 4 hematological or grade 2 neurological toxicity. When two or more patients experience DLT, the MTD was reached. Results A total of 16 patients were included; 69% had a performance status （PS） 1 （Eastern Cooperative Oncology Group, ECOG）. A total of 69% had concurrent active extra cranial diseases. All had more than 3 BM. Up to 600 mg/m^2 （level 3） no neurology toxicity was observed. At 600 mg/m^2 two out of 9 patients developed grade 4 thrombocytopenia. One of the two patients＇ thrombocytopenia was confused with disseminated intravascular coagulation （DiC）. At 700 mg/m^2 two out of 4 patients developed neurotoxicities. One developed grade 3 seizure and cognitive disorder. Another patient developed suspected grade 2 muscle weakness. Conclusions The MTD was reached at a dose of 700 mg/m^2. The dose of 600 mg/m^2 would be considered for further study.

关键词： brain metastases radiosensitisation gemcitabine phase i study

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