NCT04166721

WaKING: Wnt and checKpoint INhibition in Gastric Cancer

A Multicenter Phase II Non-randomised Trial Assessing the Efficacy of DKN-01 Plus Atezolizumab in Patients With Advanced Mismatch Repair Proficient Oesophagogastric Cancer

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Royal Marsden NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Metastatic Esophageal Cancer
• Metastatic Gastric Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab	Immunotherapy

Timeline

• Start date: 2020-02-11
• Primary completion: 2025-03-30
• Completion: 2025-12-31
• First posted: 2019-11-18
• Last updated: 2025-04-06

Locations

1 site across 1 country: United Kingdom