This is a Phase 1/2 study of GB263T in participants with advanced NSCLC and other solid tumor. The study will consist of a dose-escalation and expansion stage to determine RP2D (Phase 1), and an extension stage (Phase 2) where participants will be enrolled into indication-specific cohorts.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Participants will receive IV infusions of GB263T at increased dose level until maximum tolerated dose is reached or all planned doses are administered. Participants will receive GB263T at predefined dose levels and frequency, based upon observed safety and protocol defined criteria. The duration of each treatment cycle is 28 days.
Genesis Care
Saint Leonards, New South Wales, Australia
RECRUITINGWestmead Hospital
Westmead, New South Wales, Australia
RECRUITINGCabrini Hospital Malvern
Malvern, Victoria, Australia
RECRUITINGNumber of Participants With Adverse Events (AEs) and Serious AEs
Time frame: Screening up to follow-up (30 [+7] days after the last dose)
DLT in Phase I
Time frame: During Cycle 1 (up to 28 days)
ORR in Phase II
Time frame: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
Cmax
Time frame: At predefined intervals up to 449 days
Tmax
Time frame: At predefined intervals up to 449 days
AUC0-last
Time frame: At predefined intervals up to 449 days
AUC0-τ
Time frame: At predefined intervals up to 449 days
t1/2
Time frame: At predefined intervals up to 449 days
Cmin
Time frame: At predefined intervals up to 449 days
Rac_Cmax
Time frame: At predefined intervals up to 449 days
Rac_AUC0-τ
Time frame: At predefined intervals up to 449 days
ADA
Time frame: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
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St Vincent's Hospital Melbourne
Melbourne, Victoria, Australia
RECRUITINGPFS
Time frame: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose
DOR
Time frame: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
CBR
Time frame: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)
OS
Time frame: Up to End of Treatment (EOT) Follow Up Period (30 [+7] days after the last dose)