SHR-1701 in Subjects With Metastatic or Locally Advanced Solid Tumors
- Registration Number
- NCT03774979
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 193
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SHR-1701 SHR-1701 intravenous infusion
- Primary Outcome Measures
Name Time Method Dose escalation part： Safety and tolerability of SHR-1701 in advanced malignancies. Up to 3/4 weeks. Number of Subjects who occurs dose-limiting toxicity (DLTs).
Clinical expansion Part: Objective Response Rate（ORR） 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
Name Time Method Clinical expansion Part: Safety of SHR-1701 Up to 4 weeks after last treatment Number of subjects who occurs treatment-related Adverse Events(AEs）
Clinical expansion Part: Disease Control Rate(DCR) per RECIST1.1 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.
Clinical expansion Part: Duration of Response （DOR）per RECIST1.1 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
Clinical expansion Part:Progression-free survival(PFS) per RECIST1.1 12months (anticipated) PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1
Trial Locations
- Locations (16)
Anhui Chest Hospital-Departmen of Tumor Radiotherapy
🇨🇳Hefei, Anhui, China
Hunan Cancer Hospital-Gynecologic Oncology
🇨🇳Changsha, Hunan, China
Xinxiang Central Hospital-Department of Respiratory Physicians
🇨🇳Xinxiang, Henan, China
Cancer Hospital of Hunan Province
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine-Cancer Center
🇨🇳Guangzhou, Guangzhou, China
The First Affiliated Hospital of Zhengzhou University-Department of Medical Oncology
🇨🇳Zhengzhou, Henan, 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
Tumor Hospital of the Chinese Academy of Medical Sciences
🇨🇳Beijing, China
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Beijing Chest Hospital,Capital Medical University-Integrated Department
🇨🇳Beijing, China
ChongQing Cancer Hospital-gynecologic oncology
🇨🇳Chongqing, China
Chongqing Cancer Hospital
🇨🇳Chongqing, China