WaKING: Wnt and checKpoint INhibition in Gastric Cancer

Sponsor
Royal Marsden NHS Foundation Trust
Study ID
NCT04166721
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Esophageal Cancer
  • Metastatic Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Feb 11, 2020
Status verified
Apr 2025
Primary completion
Mar 30, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
52 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DKN-01 and atezolizumab
    DKN-01 is an intravenous medication which will be given at a variable dose during the Phase IIA safety run in phase of the trial (150mg, 300mg or 600mg IV q14d). During the Phase IIB efficacy phase of the trial patients will be treated with DKN-01 at the safe and tolerated combination dose identified during the Phase IIA safety run in phase. Atezolizumab is a monoclonal antibody which is given via an intravenous infusion at a dose of 840mg on the first day of a two week cycle. (Day 1 q 14d) from cycle 2 onwards. In the first cycle of treatment, patients will be treated with only DKN-01, and following this they will be treated with both DKN-01 and atezolizumab

Primary Outcome Measure

Safety run-in phase: To recommend a safe and tolerable dose of combination DKN-01 and atezolizumab for use in the main (Phase IIB efficacy) phase of this trial. [ Time Frame: The DLT period is 28 days from the start of the combination of DKN-01 and atezolizumab for any given patient (i.e. from C2 D1) ]

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