Actively Recruiting
A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC278 in the Treatment of Solid Tumors
Led by RemeGen Co., Ltd. · Updated on 2025-11-26
312
Participants Needed
39
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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;
CONDITIONS
Official Title
A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC278 in the Treatment of Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate and sign informed consent
- Age between 18 and 75 years, inclusive
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- At least one measurable target lesion per RECIST v1.1 imaging criteria
- Adequate bone marrow, liver, kidney, and blood clotting function
You will not qualify if you...
- Pregnant, breastfeeding, or planning pregnancy
- Presence of brain metastases
- Unresolved toxicities from prior anti-tumor therapy not recovered to Grade 1
- Known allergy or delayed hypersensitivity to components of RC278 or similar drugs
- Acute, chronic, or symptomatic infections
- Uncontrolled cardiovascular diseases
- Confirmed or suspected interstitial lung disease or severe pulmonary conditions
- History of cirrhosis classified as Child-Pugh B or C
- Active inflammatory bowel disease
- Uncontrolled diabetes with HbA1c ≥ 10%
- Recent arterial/venous thromboembolic events or stroke within 6 months
- Uncontrolled pericardial effusion, cardiac tamponade, or third-space fluid accumulation
- Active autoimmune diseases requiring systemic treatment within 2 years
- History of other invasive malignancies within 5 years or residual disease
- History of immunodeficiency or organ transplantation
- Uncontrolled psychiatric disorders
- Poor adherence or unlikely to comply with study procedures
- Any other medical condition or abnormality judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 39 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
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2
Fujian Cancer Hospital
Fuzhou, Fujian, China
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3
Fujian Cancer Hospital
Fuzhou, Fujian, China
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4
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
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5
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
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6
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
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7
Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute
Nanning, Guangxi, China
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8
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
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9
Anyang Cancer Hospital
Luoyan, Henan, China
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10
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, China
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11
Nanyang Second General Hospital
Nanyang, Henan, China
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12
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
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13
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
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14
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China
Wuhan, Hu'Nan, China
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15
Hubei Cancer Hospital
Wuhan, Hubei, China
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16
Tongji Hospital, Tongji Medical College of HUST, China
Wuhan, Hubei, China
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17
Hunan Cancer Hospital
Changsha, Hunan, China
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18
Hunan Cancer Hospital
Changsha, Hunan, China
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19
Hunan Cancer Hospital
Changsha, Hunan, China
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20
Hunan Cancer Hospital
Changsha, Hunan, China
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21
Jiangsu Province Hospital
Nanjing, Jiangsu, China
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22
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
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23
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
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24
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
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25
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
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26
The first Hospital of China Medical University
Shenyang, Liaoning, China
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27
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
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28
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
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29
West China Hospital of Sichuan University
Chengdu, Sichuan, China
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30
Yunnan Tumor Hospital
Kunming, Yunnan, China
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31
Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
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32
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
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33
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
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34
Sun Yat-sen University Cancer Center
Guangzhou, China
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35
The First Affiliated Hospital, Zhejiang University School Of Medicine
Hangzhou, China
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36
Cancer Hospital of Shandong First Medical University
Jinan, China
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37
Jinan Central Hospital
Jinan, China
Actively Recruiting
38
Shanxi Cancer Hospital
Taiyuan, China
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39
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
Research Team
X
Xiaohong Su
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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