The study will consist of two parts: a dose-escalation part (Part 1) and a dose expansion part (Part 2). In both study parts, SSGJ-705 will be administered,the administration duration may be adjusted based on outcomes of previous patients if necessary) followed by safety, PK, PD, potential anti tumor effects and immunogenicity evaluation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
162
0.1, 1, 3, 6, 10, 15 or 20mg/kg, IV, Day 1, 8, 15 of each treatment cycle, up to disease progression or intolerable toxicity, death, early withdrawal from the study or loss to follow-up, withdrawal of consent, or the end of the treatment period, whichever occurs first. Every 4 weeks a treatment cycle.
DLT
Dose-limiting toxicity(part 1)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
MTD
maximum tolerated dose(part 1)
Time frame: up to 1 years
RP2D
Objective response rate (ORR) per RECIST 1.1 criteria according to investigators recommended Phase II dose(part 1)
Time frame: up to 1 years
ORR
Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment(part 2)
Time frame: up to 1 years
Adverse events
the safety of SSGJ-705 in patients with advanced or metastatic HER2-expressing solid tumors who have failed standard treatment
Time frame: up to 1 years
Maximum Plasma Concentration (Cmax)
To evaluate the Cmax of single and multiple doses of SSGJ-705 in patients with advanced or metastatic HER2 expressing solid tumors who have failed standard treatments
Time frame: up to 1 years
Area Under the Curve (AUC)
To evaluate the AUC of single and multiple doses of SSGJ-705 in patients with advanced or metastatic HER2 expressing solid tumors who have failed standard treatments
Time frame: up to 1 years
incidence of anti-609A antibodies
incidence of anti-609A antibodies
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 1 years
Median Progression-free Survival (PFS)
The Kaplan-Meier method will be used to estimate median PFS.
Time frame: up to 1 years
Overall Survival (OS)
The Kaplan-Meier method will be used to estimate median OS.
Time frame: up to 1 years