Detailed Description: This is a multicenter, open-label, multiple-dose, first in human(FIH) Phase 1/2a trial. The Phase 1 portion uses the Bayesian optimal interval (BOIN) design to escalate doses and determine the maximum tolerated dose(MTD) and/or recommended phase 2 dose(RP2D) with potential backfill cohorts. The Phase 2a portion consists of dose optimization followed by cohort expansion to confirm safety and tolerability and further evaluate the efficacy of the selected RP2D in selected solid tumor malignancies treated with VBC117.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
VBC117 is a epidermal growth factor receptor (EGFR)x Cadherin-17 (CDH17) bispecific antibody-drug conjugate (ADC).
Macquarie University
Randwick, New South Wales, Australia
Scientia Clinical Research
Randwick, New South Wales, Australia
Cancer Care Wollongong
Wollongong, New South Wales, Australia
Incidence of AEs
Number of patients with Adverse Events(AEs)by system organ class and preferred term
Time frame: From time of Informed Consent to 30 days post last dose of VBC117
Incidence of DLTs
Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Time frame: From time of first dose of VBC117 to end of DLT period (approximately 21 days)
Incidence of SAEs
Number of patients with Serious Adverse Events(SAEs)by system organ class and preferred term
Time frame: From time of Informed Consent to 30 days post last dose of VBC117
Incidence of TEAE leading to dose modification or discontinuation
Number of patients with treatment-emergent adverse event (TEAE) leading to dose modification or discontinuation by system organ class and preferred term
Time frame: From time of Informed Consent to 30 days post last dose of VBC117
objective response rate (ORR)
The percentage or number of patients with a confirmed investigator assessed complete or partial response according to response criteria in solid tumours
Time frame: From first dose of VBC117 to disease progression or death, up to approximately 2 years
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Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
The Second Affiliated Hospital of Zhejiang University School of Medicine
Zhejiang, Hangzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Liaoning Cancer Hospital & Institute
Shengyang, Liaoning, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
...and 2 more locations