This study is a Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of RT023 in Subjects with Advanced Malignant Solid Tumour. In dose escalation and dose expasion phase, the safety, tolerability of RT023 in patients with advanced malignant solid tumors will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), recommended phase 2 dose (RP2D) of RT023. In clinical expansion phase, the preliminary antitumor activity of RT023 in target solid tumors will be evaluated. In addition, the pharmacokinetic characteristics, and immunogenicity of RT023 in patients with advanced malignant solid tumors will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
318
Intravenous (IV) Infusion
DLT
Incidence of dose-limiting toxicities (DLTs)
Time frame: Up to 12 months
Adverse Events
Incidence and severity of adverse events AEs
Time frame: Up to 36 months
MTD
Maximum tolerated dose
Time frame: Up to 12 months
RP2D
Recommended phase 2 dose
Time frame: Up to 12 months
ORR
Objective response rate (ORR) as assessed by the investigator per RECIST v1.1.
Time frame: Up to 36 months
SAEs
incidence and severity of serious adverse events (SAEs)
Time frame: Up to 36 months
DoR
Duration of response (DoR) as assessed by investigator per RECIST v1.1
Time frame: Up to 36 months
DCR
Disease control rate (DCR) as assessed by investigator per RECIST v1.1
Time frame: Up to 36 months
PFS
Progression-free survival (PFS) as assessed by the investigator per RECIST v1.1.
Time frame: Up to 36 months
OS
Overall survival (OS)
Time frame: Up to 36 months
Cmax
maximum observed concentration (Cmax)
Time frame: About 6 months after first dosing
Immunogenicity
Anti-drug antibodies (ADA) and titers
Time frame: About 6 months after first dosing
AUC0-t
area under the concentration time curve
Time frame: about 6 months after first dosing
t1/2
terminal half life (t1/2)
Time frame: about 6 months after first dosing
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.