A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC278 in the Treatment of Solid Tumors
NCT ID: NCT07105215
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
312 participants
INTERVENTIONAL
2025-08-11
2030-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RC278 (Phase I, dose escalation)
There are five escalating dose cohorts.
RC278
Intravenous (IV) administration of RC278 Q3W. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study.
RC278 (Phase I, dose expansion)
The recommended dose from the dose-escalation stage and other potential doses will be further explored.
RC278
Intravenous (IV) administration of RC278 Q3W. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study.
RC278 (Phase I, dose optimization)
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
Intravenous (IV) administration of RC278 Q3W. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study.
RC278 (Phase II)
In the multi-indication cohort expansion phase, further assess the efficacy and safety of RC278 in various cancer types using the RP2D.
RC278
Intravenous (IV) administration of RC278 Q3W. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study.
Interventions
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RC278
Intravenous (IV) administration of RC278 Q3W. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age between 18 and 75 years (including 18 and 75 years);
3. ECOG PS score of 0 or 1;
4. Expected survival ≥12 weeks;
5. According to RECIST v1.1 criteria, based on imaging examinations, there is at least one measurable target lesion;
6. Sufficient bone marrow, liver, kidney, and blood clotting function
Exclusion Criteria
2. Subjects with brain metastases.
3. Subjects with unresolved toxicities from prior anti-tumor therapy not recovered to NCI-CTCAE v5.0 Grade 1.
4. Subjects with known hypersensitivity or delayed allergic reactions to any component of the investigational drug or similar drugs.
5. Subjects with acute, chronic, or symptomatic infections.
6. Subjects with uncontrolled cardiovascular diseases.
7. Subjects with confirmed or suspected interstitial lung disease (ILD), drug-related pneumonia, radiation pneumonitis, severely impaired pulmonary function, or other pulmonary diseases.
8. Subjects with a history of cirrhosis (Child-Pugh B or C class).
9. Subjects with active inflammatory bowel disease.
10. Subjects with uncontrolled diabetes (HbA1c ≥ 10%).
11. Subjects who experienced arterial/venous thromboembolic events, deep vein thrombosis, pulmonary embolism, or stroke within 6 months prior to the first dose.
12. Subjects with pericardial effusion or cardiac tamponade, or third-space fluid accumulation, which, in the investigator's judgment, cannot be controlled or stabilized by drainage or other methods.
13. Subjects with active autoimmune diseases requiring systemic treatment within the past 2 years.
14. Subjects with a history of other invasive malignancies within 5 years prior to the first dose, or evidence of residual disease from a previously diagnosed malignancy.
15. Subjects with a history of other acquired or congenital immunodeficiency diseases or organ transplantation.
16. Subjects with a history or current diagnosis of uncontrolled psychiatric disorders.
17. Subjects with poor adherence, who are unlikely to comply with the trial procedures.
18. Subjects with any other diseases, metabolic abnormalities, physical examination abnormalities, or laboratory abnormalities, which, in the investigator's judgment, raise suspicion of an underlying condition making the subject unsuitable for the investigational drug, or which may affect the interpretation of the study results, or place the subject at high risk.
18 Years
75 Years
ALL
No
Sponsors
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RemeGen Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, China
Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute
Nanning, Guangxi, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Anyang Cancer Hospital
Luoyan, Henan, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang, Henan, China
Nanyang Second General Hospital
Nanyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China
Wuhan, Hu'Nan, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College of HUST, China
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
The first Hospital of China Medical University
Shenyang, Liaoning, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Yunnan Tumor Hospital
Kunming, Yunnan, China
Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China
Sun Yat-sen University Cancer Center
Guangzhou, , China
The First Affiliated Hospital, Zhejiang University School Of Medicine
Hangzhou, , China
Cancer Hospital of Shandong First Medical University
Jinan, , China
Jinan Central Hospital
Jinan, , China
Shanxi Cancer Hospital
Taiyuan, , China
Henan Cancer Hospital
Zhengzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Hu Xingsheng
Role: primary
Guo Zengqing
Role: primary
Huang Zhangzhou
Role: primary
Lai jinhuo
Role: primary
Wu Jingxun
Role: primary
Li Bihui
Role: primary
Zhang Qingyun
Role: primary
Wang guangyu
Role: primary
Ji yuanyuan
Role: primary
Wang Qichuan
Role: primary
Ji Yinghua
Role: primary
Jin shuiling
Role: primary
Zhang tao
Role: primary
Chu qian
Role: primary
Liu Zhenyang
Role: primary
Jiang Shusuan
Role: primary
Ouyang Quchang
Role: primary
Wu lin
Role: primary
Gu yanhong
Role: primary
Zhang Wenhui
Role: primary
Han liang
Role: primary
Sun Longhua
Role: primary
Liu Hongxv
Role: primary
Zhao Mingfang
Role: primary
Chen Zhiyu
Role: primary
Yu yiwei
Role: primary
Li mei
Role: primary
Yang Runxiang
Role: primary
Fang yong
Role: primary
Fanyun
Role: primary
Lv Dongqing
Role: primary
xu ruihua
Role: primary
Zhao qingwei
Role: primary
Zhang yan
Role: primary
Wen qing
Role: primary
Wang xin
Role: primary
Luo suxia
Role: primary
Other Identifiers
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RC278-C001
Identifier Type: -
Identifier Source: org_study_id
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