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 range18 Years
SexALL
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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
✓. 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
✕
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
. 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