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.
Males and/or females over age 18
Histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Expected survival >3 months.
Any remaining AEs > grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of hair loss, fatigue, and grade 2 peripheral neurotoxicity.
Pregnant or nursing women or women/men who are ready to give birth
Symptomatic central nervous system metastasis.
Allergy to other antibody drugs or any excipients in the study drugs.
Single group
SSGJ-705
Druganti-PD-1 and anti-HER2 bispecific antibody
DLTs
Dose limiting toxicity
AE
Safety and tolerability assessed by incidence and severity of adverse events
MTD or MAD
maximum tolerated dose or the maximum administered dose if MTD is not reached
RP2D
the recommended phase II dose
ORR
Objective response rate
PFS
Progression-free Survival
Cmax
Maximum Plasma Concentration
T1/2
Half-life
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