NCT05620628

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Jeeyun Lee · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Despite recent developments, the prognosis of patients with advanced gastric cancer is still poor, and the target treatment options studied in a recently completed randomized clinical trial in which patients with tumors expressing HER2 were treated with trastuzumab are proposed. In this study, the survival period of patients treated with trastzumab was extended to less than 3 months. Despite these results, 80% of patients are still not eligible for trastzumab and need additional targeted therapy. The largest somatic cell mutation frequency recorded in tumors can lead to higher renal antigen release and provision to the immune system. In addition, in some clinical trials, abnormal overexpression of MET was associated with poor clinical progress, rapid disease progression, and short survival period. Double blocking of PD-1 and vascular endothelial growth factor receptor 2 appeared to increase inhibition of tumor growth compared to the treatment of each monoclonal antibody alone. Therefore, in this study, the efficacy and safety of combination administration of immunoglobulin G1 that inhibits PD-L1 with MET amplification and Saboritinib (AZD6094), an MET inhibitor, are to be confirmed. Histologically identified metastatic and recurrent gastric cancer, ECOG systemic activity of 0 or 1 and at least one measurable lesion in accordance with modified RECIST 1.1 According to the NGS results, the efficacy and safety of the combination administration of dervalumab and saboritinib are evaluated for gastric cancer patients scheduled for secondary and tertiary treatment with MET amplification. Savoritinib is administered oral once a day at 600 mg (QD) every 28 days if it is more than 50 KG. Dervalumab is administered intravenously every four weeks from the first day of the first cycle CT will be used every 8 weeks from the first administration date to check the progress of the objective disease. Patients have evidence that they are resistant to treatment and useful in clinical trials, and if the supply of drugs is secured, they will continue to be treated with saboritinib and dervalumab.

Conditions

• Stomach Cancer, Adenocarcinoma

Interventions

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

Timeline

• Start date: 2023-01-05
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2022-11-17
• Last updated: 2026-01-21

Locations

1 site across 1 country: South Korea