This study includes phase I dose escalation part and phase IIa dose expansion part. The goal of this clinical trial is to learn if C5252 treatment is safe and well tolerated in patients with intracranial tumor and to learn preliminary efficacy of C5252. In this study, participants will be given single or multiple doses of C5252 according to protocol followed by toxicity observation, safety follow-up and long-term follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
C5252 will be administered at designed dose level.
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Phase I: Incidence of adverse event
TEAE, SAE, DLT, AESI during treatment period
Time frame: Up to 30 days after completion of treatment
Phase I: Determine the MTD/RP2D
Maximal Tolerated Dose/Recommended Phase 2 Dose (MTD/RP2D)
Time frame: up to 4 weeks
Phase II: Overall Survival
The overall survival for each patient receiving C5252 will be calculated.
Time frame: Up to 2 years
Phase II: OS rate
OS rate at 6, 12, 18 and 24 months after first study dose
Time frame: Up to 2 years after first dose
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