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Clinical Trials in China / NCT07105215
Recruiting Phase 1/2

A I/II Phase Clinical Study to Evaluate the Safety and Efficacy of RC278 in the Treatment of Solid Tumors

NCT07105215 · tracked via the Priya Life Science China tracker
Sponsor
RemeGen Co., Ltd.
Phase
Phase 1/2
Started
2025-08-11
Last updated
2025-11-26

Condition(s) studied

Solid Tumors

Investigational drug(s) / intervention(s)

RC278

RC278: Intravenous (IV) administration of RC278 Q3W. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study.

Study summary

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;

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Voluntarily participate in this study, sign the informed consent form, and be able to adhere to the study protocol; 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: 1. Pregnant, breastfeeding, or intending to become pregnant subjects. 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.

Primary outcome measure(s)

Trial sites (39)

FacilityCityRegionStatus
Cancer Hospital Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting
Fujian Cancer Hospital Fuzhou Fujian Recruiting
Fujian Cancer Hospital Fuzhou Fujian Recruiting
Fujian Medical University Union Hospital Fuzhou Fujian Recruiting
The First Affiliated Hospital of Xiamen University Xiamen Fujian Recruiting
The Second Affiliated Hospital of Guilin Medical University Guilin Guangxi Recruiting
Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute Nanning Guangxi Recruiting
Harbin Medical University Cancer Hospital Harbin Heilongjiang Recruiting
Anyang Cancer Hospital Luoyan Henan Recruiting
The First Affiliated Hospital of Henan University of Science &Technology Luoyang Henan Recruiting
Nanyang Second General Hospital Nanyang Henan Recruiting
The First Affiliated Hospital of Xinxiang Medical University Xinxiang Henan Recruiting
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, China Wuhan Hu'Nan Recruiting
Hubei Cancer Hospital Wuhan Hubei Recruiting
Tongji Hospital, Tongji Medical College of HUST, China Wuhan Hubei Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
Jiangsu Province Hospital Nanjing Jiangsu Recruiting
The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu Recruiting
Xuzhou Central Hospital Xuzhou Jiangsu Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Recruiting
Liaoning Cancer Hospital & Institute Shenyang Liaoning Recruiting
The first Hospital of China Medical University Shenyang Liaoning Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting
Zhongshan Hospital, Fudan University Shanghai Shanghai Municipality Recruiting
West China Hospital of Sichuan University Chengdu Sichuan Recruiting
Yunnan Tumor Hospital Kunming Yunnan Recruiting
Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
Zhejiang Cancer Hospital Hangzhou Zhejiang Recruiting
Taizhou Hospital of Zhejiang Province Taizhou Zhejiang Recruiting
Sun Yat-sen University Cancer Center Guangzhou China Recruiting
The First Affiliated Hospital, Zhejiang University School Of Medicine Hangzhou China Recruiting
Cancer Hospital of Shandong First Medical University Jinan China Recruiting
Jinan Central Hospital Jinan China Recruiting
Shanxi Cancer Hospital Taiyuan China Recruiting
Henan Cancer Hospital Zhengzhou China Recruiting

More RemeGen Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07105215 on ClinicalTrials.gov ↗ ← All trials in China