Safety, Tolerability and Pharmacokinetics of a Recombinant Humanized mAb Specific to B-and T-Lymphocyte Attenuator (BTLA) for Injection in Subjects With Advanced Malignancies

A 3-part (dose-escalation, dose-expansion and cohort-expansion) phase I clinical study of JS004 in subjects with advanced solid malignancies in China for the first time, to evaluate the safety, tolerability, PK, immunogenicity, antitumor activity and biomarkers of JS004, define the MTD and RP2D. A cycle is 21 days (3 weeks) which includes JS004 being administered IV Q3W. All patients will be treated until disease progression per RECIST v1.1 and iRECIST, or intolerable toxicity per CTCAE 5.0, withdrawal of consent, or end of the study, whichever occurs first.Disease progression must be confirmed at least 4 weeks but no longer than 8 weeks after initial documentation of progression.