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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
193
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.
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
Dose escalation part: Safety and tolerability of SHR-1701 in advanced malignancies.
Number of Subjects who occurs dose-limiting toxicity (DLTs).
Time frame: Up to 3/4 weeks.
Clinical expansion Part: Objective Response Rate(ORR)
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.
Time frame: Up to 6 weeks
Clinical expansion Part: Safety of SHR-1701
Number of subjects who occurs treatment-related Adverse Events(AEs)
Time frame: Up to 4 weeks after last treatment
Clinical expansion Part: Disease Control Rate(DCR) per RECIST1.1
DCR is define as the percentage of participants in the analysis population who have a CR,PR or SD per RECIST 1.1.
Time frame: Up to 6 weeks
Clinical expansion Part: Duration of Response (DOR)per RECIST1.1
DOR is define as the time from first documented evidence of CR or PR until disease progression per RECIST 1.1
Time frame: Up to 6 weeks
Clinical expansion Part:Progression-free survival(PFS) per RECIST1.1
PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1
Time frame: 12months (anticipated)
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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
...and 6 more locations