Assessments
Tumors, tumor, Cancer
ADVERSE EVENT, TUMOR, ADVERSE EVENTS, TUMORS, CANCER
Treatment-emergent adverse events (TEAEs) were assessed after administration of the first dose of TAK-164 and through 30 days after the last dose of TAK-164, were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5 and were tabulated according to the Medical Dictionary for Regulatory Activities (MedDRA). Response was assessed based on the modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, at screening, every 2 cycles, and at end of treatment (defined as 30 days after the last TAK-164 dose, or prior to the start of subsequent antineoplastic therapy). The proportion of patients with positive anti-drug antibodies (ADA; transient and persistent, titer and specificity) was assessed in patients with baseline and at least one post-baseline immunogenicity assessment. Serial blood samples to determine the plasma concentration and PK of TAK-164 were taken pre-dose and post-dose on day 1 and on days 2, 3, 4, 8, and 15 of cycles 1 and 2, as well as pre- and post-dose on day 1 of cycle 3 onwards.Archived tumor specimens and pre-treatment biopsies were used for analysis using a validated, semi-quantitative GCC IHC assay to confirm the presence of GCC protein expression, which was characterized by an H-score. Samples with apical H-scores ≥ 10 were considered “GCC-positive”. Target engagement of TAK-164 was assessed by measuring changes in expression of the target marker γH2AX using a validated IHC assay (NeoGenomics) and image analysis solution (Indica Labs) in paired pre- and post-treatment biopsies, obtained at screening and on day 8 of cycle 2.