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Stomach Cancer, AdenocarcinomaPhase 2NCT05620628

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

A Phase 2 study testing Durvalumab and Savolitinib in people with Stomach Cancer, Adenocarcinoma, run by Jeeyun Lee at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Stomach Cancer, Adenocarcinoma
What is being tested?
Durvalumab and Savolitinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteSouth Korea
Study dates
5 Jan 2023to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of fully informed consent prior to any study specific procedures.
  • Patients must be ≥ 19 years of age
  • Body weight >30 kg
  • MET amplification by local NGS (The NGS result of the implementation agency is defined as copy number 4 or higher, which is the standard for amplification)
  • Patients with gastric cancer (GC) who are in progressive stages and have progressed during or after 1st or 2nd chemotherapy treatment, regardless of whether they are IO contactless (naïve) or IO
  • There shall be at least one measurable lesion according to the modified RECIST 1.1 criteria.
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  • Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.
  • ECOG performance status 0-1 with no deterioration between screening and the first dose of study treatment
  • Patients must have a life expectancy ≥ 3 months from proposed first dose date.
  • Patients must have had a washout period of 2 weeks for any prior therapy prior to the start ot study drug. The following intervals between the end of the prior treatment and first dose of study drug must be observed: ≥ 4 weeks for radiotherapy (patients who receive palliative radiation for nontarget lesions need not have a 4 week washout period and can be enrolled if at least >=7 days); patients may receive a stable dose of bisphosphonates or denusomab as long as these were started at least 4 weeks prior to treatment; ≥ 4 weeks for major surgery; ≥ 7 days for minor surgical procedures; ≥ 14 days (or 5 half lives whoever is longest) for any investigational product.
  • Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below:
  • Haemoglobin ≥9.0 g/dL (within 2 weeks of registration transfusion permitted)
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelet count ≥100 x 109/L (within 2 weeks of registration transfusion permitted)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x the upper limit of normal (ULN) with TBL≤ 1x ULN OR TBL >1ULN-≤1.5x ULN with ALT and AST ≤ 1x ULN
  • Serum creatinine ≤1.5 x institutional ULN
  • Glomerular filtration rate < 45 mL/min as assessed by standard methodology at the investigating centre
  • Female patients must be using highly effective contraception during clinical trials and for three months after permanent discontinuation of drug administration, and there should be evidence that they are not breastfeeding, that they are negative in pregnancy tests, or that they meet one of the following criteria in screening:
  • Male test subjects with a likely female spouse should be asked to use blocked contraception during the clinical trial and for six months after permanent cessation of administration of the test drug. The test subjects should avoid sperm donation from the start of the test treatment to the 6th month after permanent discontinuation.
  • optionally biopsy during the screening window prior to dosing and at progression (fresh frozen will be optionally if clinically feasible)

Who cannot join

  • Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
  • Any previous treatment with MET inhibitors (prior exposure to anti-PD1/PDL1 allowed)<<if the study allows prior anti PD-1, PD-L1 and CTLA-4>> Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4:
  • Any gastrointestinal condition that would preclude adequate absorption of savolitinib including but not limited to inability to swallow oral medication, refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection, intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment.
  • Active or prior documented autoimmune or inflammatory disorders (including IBD[e.g. Chohn's disease, ulcerative colitis or diverticulitis], SLE, sarcoidosis syndrome, tuberculosis, Wegener syndrome, myasthenia gravis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, history of primary immunodeficiency.
  • Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
  • Active hepatitis B (positive HBV surface antigen (HBsAg) result) or hepatitis C (HCV).
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  • Patients with a past or resolved HBV infection are eligible if:
  • Negative for HBsAg and positive for hepatitis B core antibody [anti-HBcAb]. or:
  • Positive for HBsAg, but for > 6 months have had normal transaminases and HBV DNA levels <2000 IU/ml (ie, are in an inactive carrier state).
  • Subjects with HBV infection, characterised by positive HBsAg and/or anti-HBcAb with undetectable HBV DNA (< 10 IU/ml or under the limit of detection per local lab standard) do not require antiviral therapy prior to randomisation.
  • Patients with HBV infection, characterised by positive HBsAg and/or anti-HBcAb with detectable HBV DNA (≥ 10 IU/ml or above the limit of detection per local laboratory standard), must be treated with antiviral therapy for 2-4 weeks prior to the start of study treatment, with the choice of antivirals as per institutional practice. Following antiviral therapy initiation, subjects must show adequate viral suppression (ie, HBV DNA ≤ 2000 IU/mL) prior to randomisation. Participants will remain on antiviral therapy for the study duration and for at least 6 months after the last dose of IP Patients with positive HCV antibody are eligible only if the polymerase chain reaction is negative for HCV RNA.
  • Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression. Note: Subjects previously treated for CNS metastases that are asymptomatic, radiographically and neurologically stable for at least 4 weeks and do not require corticosteroids (of any dose) for symptomatic management for at least 4 weeks prior to the first dose of treatment are not excluded.
  • Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤3 years.
  • Current or prior use of immunosuppressive medication within 4 weeks prior to the first dose of durvalumab, with the exceptions of intranasal, topical, and inhaled corticosteroids; systemic corticosteroids at physiologic doses not to exceed a dose > 10 mg prednisone / day or equivalent)
  • Patient was in receipt of any live attenuated vaccination within 30 days prior to study entry or within 30 days of receving study therapy.
  • Patients currently receiving (or unable to stop use at least 2 weeks) prior to receiving the first dose of savolitinib, medications known to be potent inhibitors of CYP1A2 or strong inducers of CYP3A4 with a narrow therapeutic range
  • Patient with any of the following cardiac criteria:
  • -Mean QT interval corrected for heart rate (QTc) ≥ 470 ms calculated from 3 electrograms (ECGs) using Friderecia's correction . etc
  • Within 6months of treatment Any evidence of severe or uncontrolled systemic disease, including active infection (requiring antibiotics, antifungals or antivirals), diabetes type I and II, uncontrolled seizures, bleeding diatheses, severe COPD, severe Parkinson's disease.
  • Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
  • For a unresolved toxicity,
  • Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent
  • Male or female patients who are familiar with pregnancy and contraception and have no intention of contraception.
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • History of allogenic organ transplantation.
  • Past history of PD-L1 or epileptic lung disease (ILD) or evidence of clinically active epileptic lung disease
  • History of liver cirrhosis of any origin and clinical stage; or history of other serious liver disease or chronic disease with relevant liver involvement, with or without normal LFTs*, such as Hemochromatosis,Alpha-1 Antitrypsin deficiency ,Autoimmune hepatitis (AIH), Primary sclerosing cholangitis (PSC), Primary biliary cirrhosis (PBC), Biopsy-confirmed Non-Alcoholic Steatohepatitis (NASH) with advanced fibrosis, Biopsy- confirmed Alcoholic Steatohepatitis with advanced fibrosis, Wilson's disease, Hepatocellular carcinoma

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jeeyun lee, Ph,MD contact

+82-10-9933-1779

jyun.lee@samsung.com

South Korea1 site, 1 recruiting

  • Samsung Medical Center

    Seoul, 06351

    Jeeyun Lee, MD, +82-10-9933-1779, jyun.lee@samsung.com

    Jeeyun Lee, Professor

    Recruiting

Other trials in South Korea

About this study

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.

Read the 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.

Being tested
Durvalumab, Savolitinib
Medical subject headings
Stomach Neoplasms, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DurvalumabDrug

    Also called Imfinzi

    Durvalumab will be administered at 1500mg every 4 weeks from cycles 1 day 1.

  • SavolitinibDrug

    Also called AZD6094

    Savoritinib 600mg will be administered orally a day for 28 days as one cycle.

Study groups in NCT05620628
Study groupRoleWhat they receive
Savoritinib and DurvalumabExperimentalA 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.
Receives: Drug: Durvalumab; Drug: Savolitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS (progression free survival)

    Efficacy of savolitinib combination with durvalumab

    Measured: up to 2years

Secondary outcomes (1)

  1. ORR (objective response rate)

    Efficacy of savolitinib combination with durvalumab

    Measured: up to 2years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2022
  2. Study start5 Jan 2023
  3. Primary completionDec 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05620628
Sponsor's protocol ID
2022-06-110
Status last verified
Jan 2026
First submitted
3 Nov 2022
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Durvalumab and Savolitinib in people with Stomach Cancer, Adenocarcinoma, run by Jeeyun Lee at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jeeyun lee, Ph,MD (+82-10-9933-1779, jyun.lee@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (progression free survival) (time frame: up to 2years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05620628.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.

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