Actively Recruiting
Ph2 Study of Savolitinib and Durvalumab (MEDI4736) Combination in Advanced MET Amplified Gastric Cancer(VIKTORY-2)
Led by Jeeyun Lee · Updated on 2026-01-21
25
Participants Needed
1
Research Sites
229 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
For patients who failed primary chemotherapy with MET amplification, The efficacy and safety of the chemotherapy are evaluated by using dervalumab and saboritinib in combination.
CONDITIONS
Official Title
Ph2 Study of Savolitinib and Durvalumab (MEDI4736) Combination in Advanced MET Amplified Gastric Cancer(VIKTORY-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide fully informed consent before any study procedures
- Be 19 years of age or older
- Have a body weight greater than 30 kg
- Have MET amplification confirmed by local genetic testing (copy number 4 or higher)
- Have advanced gastric cancer that progressed during or after 1st or 2nd chemotherapy
- Have at least one measurable tumor lesion by modified RECIST 1.1 criteria
- Be willing and able to comply with treatment and scheduled visits
- Have an ECOG performance status of 0 or 1 with no worsening before treatment
- Have a life expectancy of at least 3 months from the first dose
- Complete required washout periods from prior therapies before starting study drugs
- Have acceptable bone marrow, liver, and kidney function within 28 days before treatment
- Women must use effective contraception during and for 3 months after treatment and not be breastfeeding
- Men with female partners must use contraception during and for 6 months after treatment
- Optional biopsy during screening and at disease progression if feasible
You will not qualify if you...
- Major surgery within 28 days before starting study treatment (except minor local palliative surgery)
- Previous treatment with MET inhibitors (prior PD-1/PD-L1 treatments allowed)
- Gastrointestinal conditions preventing proper absorption of oral medication
- Active or prior autoimmune or inflammatory diseases including certain listed conditions
- Positive tests for HIV or active tuberculosis infection
- Active hepatitis B or C infection without proper viral control
- Untreated or unstable brain metastases or related complications
- Second primary cancer except certain treated skin or in-situ cancers
- Use of immunosuppressive drugs within 4 weeks before treatment except some corticosteroids
- Recent live vaccinations within 30 days before study entry or treatment
- Use of medications affecting drug metabolism that cannot be stopped before treatment
- Certain heart conditions including prolonged QT interval
- Severe uncontrolled systemic diseases or infections within 6 months
- Unresolved toxicities from prior cancer treatments except some exceptions
- Uncontrolled illnesses or conditions limiting study compliance or consent
- Patients not intending to use contraception if applicable
- Known allergy to study drugs or their components
- History of organ transplantation
- History or presence of lung disease related to PD-L1 or epilepsy
- History of serious liver diseases or advanced liver fibrosis conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
J
Jeeyun lee, Ph,MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here