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)
Dose-Limiting Toxicity (DLT) — 24 months 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.
Incidence and severity of adverse events/serious adverse events (graded according to NCI CTCAE v5.0) — 24 months AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the CTCAE Version 5.0\].
Determine RP2D of RC278 — 24 months To determine the RP2D for further evaluation of RC278 in subjects with advanced solid tumor.
MTD and/or MAD — 24 months To determine the MTD and/or MAD for further evaluation of RC278 in subjects with advanced solid tumor.
Investigator assessed ORR according to RECIST v1.1 criteria — 24 months 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).
Trial sites (39)
Facility
City
Region
Status
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
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.
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