Nasopharyngeal Carcinoma Clinical Trial
Official title:
A Phase I/II Clinical Study of JS004, a Recombinant Humanized mAb Specific to B-and T-Lymphocyte Attenuator (BTLA), in Subjects With Head and Neck Cancer
A phase I/II clinical study of JS004 in subjects with head and neck cancer in China, to evaluate the safety, tolerability, PK, immunogenicity, antitumor activity and biomarkers of JS004, define the RP2D. A cycle is 21 days (3 weeks) which includes JS004 being administered IV Q3W and JS004 combine with JS001 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.
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