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;
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
312
Intravenous (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.
Time frame: 24 months
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 \[graded according to the CTCAE Version 5.0\].
Time frame: 24 months
Determine RP2D of RC278
To determine the RP2D for further evaluation of RC278 in subjects with advanced solid tumor.
Time frame: 24 months
MTD and/or MAD
To determine the MTD and/or MAD for further evaluation of RC278 in subjects with advanced solid tumor.
Time frame: 24 months
Investigator assessed ORR according to RECIST v1.1 criteria
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).
Time frame: 24 months
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