Oh DY, et al. - Researchers conducted a phase 1b/2 study of varlitinib plus gemcitabine and cisplatin (gem/cis) in biliary tract cancer (BTC) using a modified 3+3+3 escalation design in phase 1b, with two varlitinib dose levels (200 and 300 mg BID) plus gem/cis on day 1 and 8 in a 3 week cycle, to understand the safety profile and to assess the maximum tolerated dose (MTD) of the combination. As of September 10, 2018, they enrolled 21 patients (11 in 200 mg cohort and 10 in 300 mg cohort, with 9 and 4 evaluable for MTD, respectively). Among 19 patients who were on varlitinib ≥ 1 month, 7 displayed partial response and 10 attained stable disease (all > 12 weeks), giving an overall response rate of 37% and a disease control rate of 89%. Findings suggest that the 200 mg cohort was able to tolerate varlitinib plus gem/cis, while the 300 mg cohort is ongoing. Outcomes support its preliminary anti-tumor activity.