Ph2 Study of Savolitinib and Durvalumab (MEDI4736) Combination in Advanced MET Amplified Gastric Cancer(VIKTORY-2)

Sponsor
Jeeyun Lee
Study ID
NCT05620628
Phase
PHASE2
Status
Recruiting
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Conditions

  • Stomach Cancer, Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Durvalumab will be administered at 1500mg every 4 weeks from cycles 1 day 1.
  • Savolitinib — DRUG
    Savoritinib 600mg will be administered orally a day for 28 days as one cycle.

Study Details

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.

Key Dates

Start date
Jan 5, 2023
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

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

Arms

  • Experimental: Savoritinib and Durvalumab
    A fixed dose of 1500 mg Q4W durvalumab (equivalent to 20 mg/kg Q4W) is used in the present study for patients \>30 kg (dosing by bodyweight only required for patients ≤30 kg).And Savolitinib will be administered orally 600mg once a day for 28 days as one cycle.

Primary Outcome Measure

PFS (progression free survival) [ Time Frame: up to 2years ]

Central Contacts