WaKING: Wnt and checKpoint INhibition in Gastric Cancer (NCT04166721) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
WaKING: Wnt and checKpoint INhibition in Gastric Cancer
United Kingdom52 participantsStarted 2020-02-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed Informed Consent Form
. Male or female patients age ≥18 years at time of signing Informed Consent Form
. Ability to comply with the study protocol, in the investigator's judgment
. Histologically or cytologically confirmed advanced or metastatic gastroesophageal adenocarcinoma. Patients with HER2 positive cancer are permitted after having received HER2 targeted therapy in first line as per Standard of Care
. Disease progression during or following treatment with one or two lines of treatment for advanced disease, one of which must have been a platinum and fluoropyrimidine combination.
. Measurable, or non-measurable but evaluable, disease per RECIST v1.1
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
Timeframe: 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)
2
Main phase IIB (efficacy) phase: Best objective response rate (ORR) using RECIST 1.1 criteria
. Evidence of tumor mismatch repair proficiency and/or MSI stability through testing of a representative tumor tissue specimen using immunohistochemistry for MMR proteins or MSI testing. Local testing or historical results of archival tumour tissue is satisfactory for trial entry.
. ECOG 0-1
Exclusion criteria
. Any contraindication or known hypersensitivity reaction to any of the study drugs
. Persisting toxicity relating to prior therapy of \>grade 1 CTCAE version 5.0 except alopecia of any grade and neuropathy ≤ grade 2, or other grade ≤2 not constituting a safety risk based on investigators judgement
. Any prior treatment with immunotherapy including anti-PD-1or PD-L1 therapy
. known active or untreated CNS metastases are excluded. Patients with treated and asymptomatic CNS metastases are eligible, if they meet all of the following:
. Evaluable or measurable disease outside the CNS
. No metastases to midbrain, pons, medulla, or within 10 mm of the optic nerves and chiasm
. No history or evidence of intracranial haemorrhage or spinal cord haemorrhage
. No evidence of clinically significant vasogenic oedema