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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1701 | Experimental | intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1701 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose escalation part: Safety and tolerability of SHR-1701 in advanced malignancies. | Number of Subjects who occurs dose-limiting toxicity (DLTs). | 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. | Up to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical expansion Part: Safety of SHR-1701 | Number of subjects who occurs treatment-related Adverse Events(AEs) | Up to 4 weeks after last treatment |
| Clinical expansion Part: Disease Control Rate(DCR) per RECIST1.1 |
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Inclusion Criteria:
Other protocol-defined inclusion criteria could apply.
Exclusion Criteria:
Other protocol-defined exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Jifeng Feng, MD | Jiangsu Cancer Institute & Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Chest Hospital-Departmen of Tumor Radiotherapy | Hefei | Anhui | China | |||
| The First Affiliated Hospital of Guangzhou University of Chinese Medicine-Cancer Center |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000723862 | SHR-1701 |
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DCR is define as the percentage of participants in the analysis population who have a CR,PR or SD per RECIST 1.1.
| 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 | 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 | 12months (anticipated) |
| 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 | 215006 | China |
| The First Affiliated Hospital Of Nanchang University | Nanchang | Jiangxi | 330006 | China |
| The First Hospital of China Medical University-Department of Oncology | Shenyang | Liaoning | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | 250012 | 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 |