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SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774979
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief Summary:
The main purpose of this study is to assess the safety and tolerability of SHR-1701 at different dose levels. Study consists of dose-escalation part and an expansion part in subjects with metastatic or locally advanced solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: SHR-1701 Phase 1

Detailed Description:
This is a Phase I, open-label, multiple-ascending dose trial. Study consists of dose-escalation part in subjects with metastatic or locally advanced solid tumors, and expansion part with selected indications.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-label Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors With Expansion to Selected Indications
Actual Study Start Date : January 24, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : January 1, 2022

Arm Intervention/treatment
Experimental: SHR-1701
intravenous infusion
Drug: 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.




Primary Outcome Measures :
  1. Dose escalation part: Safety and tolerability of SHR-1701 in advanced malignancies. [ Time Frame: Up to 3/4 weeks. ]
    Number of Subjects who occurs dose-limiting toxicity (DLTs).

  2. Clinical expansion Part: Objective Response Rate(ORR) [ Time Frame: Up to 6 weeks ]
    ORR is define as the percentage of participants in the analysis population who havea Complete Response(CR:Disappearance of all target lesions)or a Partial Response(PR :30% decrease in the sum of diameter of target lesions) per RECIST 1.1.


Secondary Outcome Measures :
  1. Clinical expansion Part: Safety of SHR-1701 [ Time Frame: Up to 4 weeks after last treatment ]
    Number of subjects who occurs treatment-related Adverse Events(AEs)

  2. Clinical expansion Part: Disease Control Rate(DCR) per RECIST1.1 [ Time Frame: Up to 6 weeks ]
    DCR is define as the percentage of participants in the analysis population who have a CR,PR or SD per RECIST 1.1.

  3. Clinical expansion Part: Duration of Response (DOR)per RECIST1.1 [ Time Frame: Up to 6 weeks ]
    DOR is define as the time from first documented evidence of CR or PR until disease progression per RECIST 1.1

  4. Clinical expansion Part:Progression-free survival(PFS) per RECIST1.1 [ Time Frame: 12months (anticipated) ]
    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able and willing to provide signed informed consent form, and able to comply with all procedures.
  • 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

Other protocol-defined inclusion criteria could apply.

Exclusion Criteria:

  • Prior therapy with an anti-PD1, anti-PD-L1, anti-CTLA-4 or a TGFb inhibitor.
  • 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

Other protocol-defined exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774979


Contacts
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Contact: Linna Wang, MD +86-21-68868570 wanglinna@hrglobe.cn
Contact: Ye Xia, MD xiaye@hrglobe.cn

Locations
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China, Anhui
Anhui Chest Hospital-Departmen of Tumor Radiotherapy Recruiting
Hefei, Anhui, China
Contact: Xuhong Min         
China, Guangzhou
The First Affiliated Hospital of Guangzhou University of Chinese Medicine-Cancer Center Recruiting
Guangzhou, Guangzhou, China
Contact: Lizhu Du         
China, Henan
Xinxiang Central Hospital-Department of Respiratory Physicians Recruiting
Xinxiang, Henan, China
Contact: Yan Peng         
The First Affiliated Hospital of Zhengzhou University-Department of Medical Oncology Recruiting
Zhengzhou, Henan, China
Contact: Yaxing Li         
China, Hunan
Cancer Hospital of Hunan Province Recruiting
Changsha, Hunan, China
Contact: Jianhua Chen         
Hunan Cancer Hospital-Gynecologic Oncology Recruiting
Changsha, Hunan, China
Contact: Dihong Tang         
China, Jiangsu
Jangsu Cancer Hospital Recruiting
Nanjing, Jiangsu, China
Contact: Jifeng Feng, MD         
The First Rffiurted Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China, 215006
Contact: Jianan Huang         
China, Jiangxi
The First Affiliated Hospital Of Nanchang University Recruiting
Nanchang, Jiangxi, China, 330006
Contact: Jianping Xiong         
China, Liaoning
The First Hospital of China Medical University-Department of Oncology Recruiting
Shenyang, Liaoning, China
Contact: Yunpeng Liu         
China, Shandong
Qilu Hospital of Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Youzhong Zhang         
China, Zhejiang
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine Recruiting
Hangzhou, Zhejiang, China
Contact: Yong Fang         
China
Beijing Chest Hospital,Capital Medical University-Integrated Department Recruiting
Beijing, China
Contact: Baolan Li         
Tumor Hospital of the Chinese Academy of Medical Sciences Recruiting
Beijing, China
Contact: Yangkai Shi         
ChongQing Cancer Hospital-gynecologic oncology Recruiting
Chongqing, China
Contact: Qi Zhou         
Chongqing Cancer Hospital Recruiting
Chongqing, China
Contact: Huiqing Yu, Doctor         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Jifeng Feng, MD Jiangsu Cancer Institute & Hospital
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03774979    
Other Study ID Numbers: SHR-1701-I-102
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
SHR-1701
Solid tumor
Metastatic or locally advanced solid tumors
Additional relevant MeSH terms:
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Neoplasms