This study is evaluating of RC118 in people with locally advanced, unresectable or metastatic solid cancersPhase 1, First-in-Human, Multicentre, Open-label Study of RC118 for Injection in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours

Exclusion

1. Women who are pregnant or breastfeeding.
2. Diagnosed active hepatitis B infection (defined as positive of hepatitis B surface Ag and hepatitis B DNA≥500IU/ml), active hepatitis C infection (defined as presence of hepatitis C RNA), and human immunodeficiency virus infection (defined as positive HIV test) during the screening period.
3. Received vaccines within 4 weeks prior to administration or plan on receiving any vaccine during the study.
4. Subjects with a history of other acquired/congenital immunodeficiency diseases or organ transplantation.
5. Patients have history of targeted therapy of Claudins, or participated in other clinical trials and received investigational product within 4 weeks before the first administration of study drug.
6. Allergic constitution or allergic to known research drug active ingredients or excipient.
7. Patients who are under the treatment of anticoagulant drugs (e.g., warfarin, apixaban, and heparin). Patients using prophylactic doses of heparin (e.g., LMWH) is eligible in the study.
8. Patients undergoing any anti-tumour therapy, including surgery, chemotherapy, radiotherapy and biological therapy, within 4 weeks prior to the first administration of study drug, or palliative radiotherapy for bone/other solitary metastases within 2 weeks prior to the first administration of study drug.
9. Previous adverse reactions resulting from previous anti-tumour therapies, which have not returned to Grade 0 or 1 according to NCI-CTCAE v5.0 (except alopecia) at screening.
10. There are clinical symptoms of fluid in the third space (e.g., large amounts of pleural fluid or ascites) that cannot be controlled by drainage or other therapies.
11. A clinically significant active infection judged by the investigator.
12. Comorbidities that may seriously endanger the patient's safety or affect the completion of the study, such as gastrointestinal bleeding (within 4 weeks prior to the screening period), peptic ulcer, intestinal obstruction, intestinal paralysis, interstitial pneumonia, pulmonary fibrosis, kidney failure, and uncontrolled diabetes.
13. QTc interval > 480 ms in both male and female (based on the mean value of the triplicate screening ECGs); family or personal history of long/short QT syndrome, History of ventricular arrhythmia deemed clinically significant by the investigator, or currently receiving antiarrhythmic drug treatment, or implantation of arrhythmia defibrillation device.
14. History of myocardial infarction within 6 months prior to the screening period, severe or unstable angina pectoris, coronary or peripheral artery bypass grafting, heart failure ≥ 3 (New York Heart Association), or uncontrolled hypertension.
15. Patients with known current alcohol dependence or drug abuse.
16. Patients with a long-term history of systemic steroid therapy. Patients with short-term (≤ 7 days) use and drug withdrawal > 2 weeks are eligible.
17. History or presence of uncontrolled primary brain tumours (e.g., leptomeningeal carcinomatosis) or metastatic brain tumours, unless considered stable by the Investigator and local therapy was completed.
18. History or presence of Grade ≥ 2 peripheral neuropathy.
19. History or presence of uncontrolled mental illness at the discretion of the Investigator, which may place the participant at increased risk of safety/tolerability issues.
20. The patient is, in the opinion of the investigator, expected to be non-compliant with critical trial procedures and is not willing or able to adhere to the trial requirements in the future.
21. Patients who are not appropriate for this clinical trial at the discretion of the investigator.