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Efficacy and Safety of the Anti-PD-L1 mAb Socazolimab for Recurrent or Metastatic Cervical Cancer: a Phase I Dose-Escalation and Expansion Study

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单位: [1]Chinese Acad Med Sci & Peking Union Med Coll, Dept Gynecol Oncol, Natl Canc Ctr, Natl Clin Res Ctr Canc,Canc Hosp, Beijing 100021, Peoples R China [2]Hunan Tumor Hosp, Changsha, Hunan, Peoples R China [3]Lees Pharmaceut Holdings Ltd, Hong Kong, Peoples R China [4]Huazhong Univ Sci & Technol, Tongji Hosp, Tongji Med Coll, Wuhan, Peoples R China [5]Wuhan Univ, Zhongnan Hosp, Wuhan, Peoples R China [6]Henan Canc Hosp, Zhengzhou, Henan, Peoples R China [7]Liaoning Canc Hosp, Shenyang, Liaoning, Peoples R China [8]Chongqing Canc Hosp, Chongqing, Peoples R China [9]Fujian Canc Hosp, Fuzhou, Fujian, Peoples R China [10]Guangxi Med Univ, Affiliated Tumor Hosp, Nanning, Guangxi, Peoples R China [11]Harbin Med Univ, Affiliated Tumor Hosp, Harbin, Heilongjiang, Peoples R China [12]Yunnan Tumor Hosp, Kunming, Yunnan, Peoples R China [13]Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Wuhan, Peoples R China
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Purpose: This study ( ClinicalTrials.gov identifier, NCT03676959) is an open, phase I dose-escalation and expansion study investigating the safety and efficacy of the recombinant, fully human anti-programmed death ligand 1 (PD-L1) mAb socazolimab in patients diagnosed with recurrent or metastatic cervical cancer. Patients and Methods: Patients received socazolimab every 2 weeks until disease progression. The study was divided into a dose-escalation phase and a dose-expansion phase. Safety and tolerability were primary endpoints of the dose-escalation phase. The primary endpoints of the dose-expansion phase were safety and the objective response rate (ORR) of the 5 mg/kg dose. Efficacy was assessed by the third-party independent review committee (IRC) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Results: 104 patients were successfully enrolled into the study. Twelve patients were included in the dose-escalation phase, with one complete response and two partial responses in the 5 mg/kg treatment group. Ninety-two patients (5 mg/kg) were enrolled in the dose-expansion phase. Fifty-four patients (59.3%) had baseline PDL1-positive tumor expression (combined positive score =1). ORR was 15.4% [95% confidence interval (CI), 8.7%-24.5%]. Median PFS was 4.44 months (95% CI, 2.37-5.75 months), and the median OS was 14.72 months (95% CI, 9.59-NE months). ORR of PD-L1positive patients was 16.7%, and the ORR of PD-L1-negative patients was 17.9%. No treatment-related deaths occurred. Conclusions: Our study demonstrates that socazolimab has durable safety and efficacy for the treatment of recurrent or metastatic cervical cancer and exhibits a safety profile similar to other anti-PD-1/PD-L1 mAbs.

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大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2025]版:
大类 | 1 区 医学
小类 | 2 区 肿瘤学
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Q1 ONCOLOGY
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Q1 ONCOLOGY

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第一作者单位: [1]Chinese Acad Med Sci & Peking Union Med Coll, Dept Gynecol Oncol, Natl Canc Ctr, Natl Clin Res Ctr Canc,Canc Hosp, Beijing 100021, Peoples R China
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