Pharmacokinetics and immunogenicity
Secondary objectives of the phase 1b trial include anti-tumor activity, pharmacokinetics, immunogenicity profiles, and potential biomarkers. Plasma samples from patients in cohort A1, A2, B1, and B2 were obtained for pharmacokinetic analysis. A summary of the PK parameters is shown in Supplementary Tab The incidence of antibodies to JMT101 was low (18/132, 13.6%). Among all positive samples, three samples had antibody titer greater than 10. No patients had persistent antibody positivity. Neither antibody positivity nor antibody titer exerted evident impact on pharmacokinetics, efficacy, and safety of JMT101.