AGC patients who had failed 1st line fluoropyrimidine-containing chemotherapy, with evidence of both EGFR and HER2 overexpression by IHC (≥1+), were enrolled….Among 27 patients treated with RP2D including 5 subjects from Phase Ib, median PFS and OS were 4.1 (95% CI, 2.4-4.9 months) and 7.9 months (95% CI, 3.3-12.5 months), respectively. Among 16 patients with measurable disease and administered with RP2D, confirmed response and disease control was observed in 5 patients (ORR=31.3%) and 14 patients (DCR=87.5%), respectively....Varlitinib combined with paclitaxel revealed manageable toxicities and antitumor activity in patients with EGFR/HER2 co-expressing AGC who progressed after first-line chemotherapy.