This study was an open-label phase I study to evaluate the safety, tolerability, PK profile and potential efficacy of SSGJ-705 as a single agent in patients with advanced malignancies.
This study includes 4 Parts: Part 1 (dose escalation and dose extension for QW administration), Part 2 (dose escalation and dose extension for Q2W administration), Part 3 (dose escalation and dose extension for Q3W administration), and Part 4 (indication extension, such as HER2 expression, PD-L1 high expression, driver gene negative newly treated advanced NSCLC, or other tumors).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
anti-PD-1 and anti-HER2 bispecific antibody
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China
RECRUITINGDLTs
Dose limiting toxicity
Time frame: 14 days
AE
Safety and tolerability assessed by incidence and severity of adverse events
Time frame: up to 1 year
MTD or MAD
maximum tolerated dose or the maximum administered dose if MTD is not reached
Time frame: up to 1 year
RP2D
the recommended phase II dose
Time frame: up to 1 year
ORR
Objective response rate
Time frame: up to 1 year
PFS
Progression-free Survival
Time frame: up to 1 year
Cmax
Maximum Plasma Concentration
Time frame: up to 1 year
T1/2
Half-life
Time frame: up to 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.