This clinical trial is an open-label, single-arm, non-randomized, dose-escalation and dose-expansion study targeting subjects with unresectable, advanced, malignant solid tumors who have failed or are unsuitable for standard treatments or refused the existing treatments. This study is divided into a dose-escalation phase (Phase I) and a dose-expansion phase (Phase II). Phase I (dose escalation) is designed to preliminarily evaluate the safety and tolerability of VIB305 in advanced solid tumors, to determine the nature and incidence of dose-limiting toxicities (DLTs), and thereby to identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). Based on the findings from the Phase I portion for evaluation in the Phase II portion. Phase II (dose expansion) will enroll additional cohorts to further assess the safety and tolerability, PK profile, preliminary antitumor activity and immunogenicity of VIB305 in specific tumor types (selected based on all available data).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
146
Intravenous infusion: once every week, each treatment cycle is 3 weeks.
Sunshine Coast University Private Hospital
Sunshine Coast, Australia
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGMTD and/or RP2D based on the incidence and nature of DLTs
Incidence of dose-limiting toxicities (DLTs)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Adverse events(AE)
Include SAEs, TEAEs
Time frame: From signed ICF to 30 days after the last drug administration
The immunogenicity of VIB305
Specification and quantification of ADAs or NAb
Time frame: Pre-dose of Cycle 1, Cycle 1 Day 15, pre-dose of Cycle 2, Cycle 2 Day 15, pre-dose of Cycle 3, Cycle 4 and following cycle(each cycle is 21 days) , 30 days after the last administration, 90 days after the last administration
Objective response rate (ORR)
The proportion of subjects who achieved a confirmed response of complete response (CR) or partial response \[PR\]
Time frame: From signed ICF to 30 days after the last drug administration
Duration of response (DOR)
The time between the first assessment of objective remission of a tumor and death from any cause before the first assessment of Disease progression (PD)
Time frame: From signed ICF to 30 days after the last drug administration
Disease control rate(DCR)
The proportion of patients who achieved complete response (CR), partial response (PR), and stable lesion (SD) after tumor treatment and could maintain the minimum duration requirement
Time frame: From signed ICF to 30 days after the last drug administration
Progression-free survival (PFS)
The time from the date of enrollment to the earlier of the dates of the first objective documentation of radiographic PD based on RECIST version 1.1 or death due to any cause
Time frame: From signed ICF to 30 days after the last drug administration
The pharmacokinetics (PK) profile of VIB305(Maximum concentration (Cmax))
Maximum concentration (Cmax)
Time frame: Cycle 1(Day 1, Day 2, Day 4,Day 6, Day 8, Day 15), Cycle 2(Day 1,Day 2, Day 4,Day 6, Day 8), Cycle 3 Day 1 and following cycle Day 1, each cycle is 21 days
The pharmacokinetics (PK) profile of VIB305(Time of Cmax (Tmax))
Time of Cmax (Tmax)
Time frame: Cycle 1(Day 1, Day 2, Day 4,Day 6, Day 8, Day 15), Cycle 2(Day 1,Day 2, Day 4,Day 6, Day 8), Cycle 3 Day 1 and following cycle Day 1, each cycle is 21 days
The pharmacokinetics (PK) profile of VIB305(Area under the curve (AUC))
Area under the curve (AUC)
Time frame: Cycle 1(Day 1, Day 2, Day 4,Day 6, Day 8, Day 15), Cycle 2(Day 1,Day 2, Day 4,Day 6, Day 8), Cycle 3 Day 1 and following cycle Day 1, each cycle is 21 days
The pharmacokinetics (PK) profile of VIB305(Terminal half-life (t½))
Terminal half-life (t½)
Time frame: Cycle 1(Day 1, Day 2, Day 4,Day 6, Day 8, Day 15), Cycle 2(Day 1,Day 2, Day 4,Day 6, Day 8), Cycle 3 Day 1 and following cycle Day 1, each cycle is 21 days
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