SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors
NCT ID: NCT03774979
Last Updated: 2022-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
193 participants
INTERVENTIONAL
2019-01-24
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SHR-1701
intravenous infusion
SHR-1701
Subjects will receive an intravenous infusion of SHR-1701 in a pre-set dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
Interventions
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SHR-1701
Subjects will receive an intravenous infusion of SHR-1701 in a pre-set dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically proven metastatic or locally advanced solid tumors.
* Male or female subjects aged 18-75 years.
* Life expectancy \>= 12 weeks as judged by the Investigator.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry.
* Disease must be measurable with at least 1 uni dimensional measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
* Adequate hematological, hepatic and renal function as defined in the protocol
Exclusion Criteria
* Anticancer treatment within 28 days before the first dose of study drug.
* Major surgery within 28 days before start of trial treatment.
* Systemic therapy with immunosuppressive agents within 7 days prior to the first dose of study drug; or use any investigational drug within 28 days before the start of trial treatment.
* With any active autoimmune disease or history of autoimmune disease.
* With active central nervous system (CNS) metastases causing clinical symptoms or requiring therapeutic intervention.
* Clinically significant cardiovascular and cerebrovascular diseases
* History of immunodeficiency including seropositive for human immunodeficiency virus (HIV), or other acquired or congenital immunedeficient disease, or any active systemic viral infection requiring therapy.
* Previous malignant disease (other than the target malignancy to be investigated in the trial) within the last 2 years. Subjects with history of cervical carcinoma in situ, superficial or non-invasive bladder cancer or basal cell or squamous cell cancer in situ previously treated with curative intent are NOT excluded.
* Receipt of any organ transplantation, including allogeneic stem-cell transplantation
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jifeng Feng, MD
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Cancer Institute & Hospital
Locations
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Anhui Chest Hospital-Departmen of Tumor Radiotherapy
Hefei, Anhui, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine-Cancer Center
Guangzhou, Guangzhou, China
Xinxiang Central Hospital-Department of Respiratory Physicians
Xinxiang, Henan, China
The First Affiliated Hospital of Zhengzhou University-Department of Medical Oncology
Zhengzhou, Henan, China
Cancer Hospital of Hunan Province
Changsha, Hunan, China
Hunan Cancer Hospital-Gynecologic Oncology
Changsha, Hunan, China
Jangsu Cancer Hospital
Nanjing, Jiangsu, China
The First Rffiurted Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of China Medical University-Department of Oncology
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China
Beijing Chest Hospital,Capital Medical University-Integrated Department
Beijing, , China
Tumor Hospital of the Chinese Academy of Medical Sciences
Beijing, , China
ChongQing Cancer Hospital-gynecologic oncology
Chongqing, , China
Chongqing Cancer Hospital
Chongqing, , China
Countries
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Other Identifiers
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SHR-1701-I-102
Identifier Type: -
Identifier Source: org_study_id
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