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;
Voluntarily participate in this study, sign the informed consent form, and be able to adhere to the study protocol;
Age between 18 and 75 years (including 18 and 75 years);
ECOG PS score of 0 or 1;
Expected survival ≥12 weeks;
Pregnant, breastfeeding, or intending to become pregnant subjects.
Subjects with brain metastases.
Subjects with unresolved toxicities from prior anti-tumor therapy not recovered to NCI-CTCAE v5.0 Grade 1.
Subjects with known hypersensitivity or delayed allergic reactions to any component of the investigational drug or similar drugs.
Parallel
RC278
DrugIntravenous (IV) administration of RC278 Q3W. Patients will continue treatment until unacceptable toxicities, disease progression, or any criterion for withdrawl from the study.
Dose-Limiting Toxicity (DLT)
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)
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
To determine the RP2D for further evaluation of RC278 in subjects with advanced solid tumor.
MTD and/or MAD
To determine the MTD and/or MAD for further evaluation of RC278 in subjects with advanced solid tumor.
Click on the lead sponsor to view all of their trials.
