A multi-centre phase II open label non-randomised trial of DKN-01 plus atezolizumab in patients with advanced inoperable or metastatic mismatch repair proficient gastroesophageal cancer (GC) who have progressed following chemotherapy. This trial is designed to evaluate the safety and efficacy of administering DKN-01, a DKK1 inhibitor plus atezolizumab, an anti-PD-L1 monoclonal antibody in this patient cohort. This trial is in 2 stages: the first stage (Phase IIA, 3+3 safety run-in) will establish a safe and tolerated dose of DKN-01 in combination with atezolizumab and the second stage (Phase IIB, Single Stage A'hern design for efficacy/ anti-tumour activity) will assess the efficacy of this combination therapy in achieving tumour response according to RECIST 1.1 criteria (additional iRECIST criteria will be used in a sensitivity analysis).
This is a multicentre open-label non-randomised, Single Stage Ahern Design (with a 3+3 design for the safety run-in) phase II clinical trial of DKN-01 plus atezolizumab in patients with advanced unresectable or metastatic OGA who have progressed following chemotherapy.