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

NCT05620628 | Recruiting Phase 2

• 1 other identifier: 2022-06-110
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stomach Cancer, Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• PFS (progression free survival)

  Efficacy of savolitinib combination with durvalumab

  up to 2years

Secondary Outcomes (1)

• ORR (objective response rate)

  up to 2years

Study Arms (1)

Savoritinib and Durvalumab

EXPERIMENTAL

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.

Drug: Durvalumab; Drug: Savolitinib

Interventions

Durvalumab DRUG

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

Also known as: Imfinzi

Savoritinib and Durvalumab

Savolitinib DRUG

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

Also known as: AZD6094

Savoritinib and Durvalumab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Jeeyun Lee: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Adenocarcinoma

Interventions

durvalumab; 1-(1-(imidazo(1,2-a)pyridin-6-yl)ethyl)-6-(1-methyl-1H-pyrazol-4-yl)-1H-(1,2,3)triazolo(4,5-b)pyrazine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Jeeyun lee, Ph,MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeeyun lee, Ph,MD

CONTACT

+82-10-9933-1779; jyun.lee@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 17, 2022
• Study Start: January 5, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)