Primary objectives: * To evaluate the safety and tolerability of BAT8009 in patients with advanced solid tumours. * To determine the maximum tolerated dose (MTD) and recommended dose for Phase 2 (RP2D).
This is a first-in-human (FIH), multicentre, open-label, Phase 1 dose escalation and dose expansion study of BAT8009 (a B7H3-targeting antibody-drug conjugate) in patients with advanced solid tumours.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30\~120 minutes.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGDose-limiting toxicity(DLT)
A DLT is defined as a toxicity occurring during the DLT observation period
Time frame: A minimum of 21 days after first dose of BAT8009
Cmax (Maximum serum concentration)
Maximum observed plasma or serum concentration
Time frame: 126 days after first dosing
Immunogenicity
Presence of ADAs / neutralizing antibodies (NAbs).
Time frame: 126 days after first dosing
AUC0-inf after Cycle 1 administration and AUC0- λ after Cycle 6 administration
area under the serum concentration versus time curve from time zero to infinity and to time λ
Time frame: 126 days after first dosing
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.