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The primary objective is to evaluate the safety and tolerability of RC278; determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of RC278; and determine the recommended phase 2 dose (RP2D), and assess the efficacy of RC278 at the RP2D dose;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC278 (Phase I, dose escalation) | Experimental | There are five escalating dose cohorts. |
|
| RC278 (Phase I, dose expansion) | Experimental | The recommended dose from the dose-escalation stage and other potential doses will be further explored. |
|
| RC278 (Phase I, dose optimization) | Experimental | Based on the safety, pharmacokinetic (PK), and efficacy data from the subjects, select at least two dose levels and randomly assign subjects in a 1:1 ratio to determine the recommended Phase II dose (RP2D) for entering the Phase II stage. |
|
| RC278 (Phase II) | Experimental | In the multi-indication cohort expansion phase, further assess the efficacy and safety of RC278 in various cancer types using the RP2D. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC278 | Drug | Intravenous (IV) administration of RC278 Q3W. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Limiting Toxicity (DLT) | DLT is defined as the adverse events (AEs) occurring during the DLT observation period that the investigator determines to be related to the RC278 treatment. | 24 months |
| Incidence and severity of adverse events/serious adverse events (graded according to NCI CTCAE v5.0) | AE assessed by investigator exclusively related to subject's underlying disease or medical condition [graded according to the CTCAE Version 5.0]. | 24 months |
| Determine RP2D of RC278 | To determine the RP2D for further evaluation of RC278 in subjects with advanced solid tumor. | 24 months |
| MTD and/or MAD | To determine the MTD and/or MAD for further evaluation of RC278 in subjects with advanced solid tumor. | 24 months |
| Investigator assessed ORR according to RECIST v1.1 criteria | Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline. ORR is evaluated by the number of participants with best overall response of CR and PR (Confirmed CR/PR assessment require at least 1 repeat). | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohong Su | Contact | +8610-65018841 | na.su@remegen.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | China |
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| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | China |
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| Fujian Cancer Hospital | Recruiting | Fuzhou | Fujian | China |
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| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | China |
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| The First Affiliated Hospital of Xiamen University | Recruiting | Xiamen | Fujian | China |
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| The Second Affiliated Hospital of Guilin Medical University | Recruiting | Guilin | Guangxi | China |
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| Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute | Recruiting | Nanning | Guangxi | China |
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| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | China |
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| Anyang Cancer Hospital | Recruiting | Luoyan | Henan | China |
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| The First Affiliated Hospital of Henan University of Science &Technology | Recruiting | Luoyang | Henan | China |
| Nanyang Second General Hospital | Recruiting | Nanyang | Henan | China |
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| The First Affiliated Hospital of Xinxiang Medical University | Recruiting | Xinxiang | Henan | China |
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| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | China |
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| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China | Recruiting | Wuhan | Hu'Nan | China |
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| Hubei Cancer Hospital | Recruiting | Wuhan | Hubei | China |
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| Tongji Hospital, Tongji Medical College of HUST, China | Recruiting | Wuhan | Hubei | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | China |
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| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | China |
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| Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | China |
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| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | China |
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| Xuzhou Central Hospital | Recruiting | Xuzhou | Jiangsu | China |
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| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | China |
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| Liaoning Cancer Hospital & Institute | Recruiting | Shenyang | Liaoning | China |
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| The first Hospital of China Medical University | Recruiting | Shenyang | Liaoning | China |
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| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | China |
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| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
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| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | China |
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| Yunnan Tumor Hospital | Recruiting | Kunming | Yunnan | China |
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| Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | China |
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| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | China |
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| Taizhou Hospital of Zhejiang Province | Recruiting | Taizhou | Zhejiang | China |
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| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | China |
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| The First Affiliated Hospital, Zhejiang University School Of Medicine | Recruiting | Hangzhou | China |
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| Cancer Hospital of Shandong First Medical University | Recruiting | Jinan | China |
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| Jinan Central Hospital | Recruiting | Jinan | China |
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| Shanxi Cancer Hospital | Recruiting | Taiyuan | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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