Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma Clinical Trial
— SpotlightOfficial title:
A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Verified date | June 2024 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A study of zolbetuximab (IMAB362) plus mFOLFOX6 versus placebo plus mFOLFOX6 in subjects with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Why is this study being done? SPOTLIGHT is a new clinical study for adult patients who have any of: - advanced unresectable gastric or GEJ cancer - metastatic gastric or GEJ cancer. These types of cancers have a unique set of proteins (called Claudin 18.2). We may be able to use a treatment that targets the proteins to kill the cancer cells. For patients with one of the types of cancer listed above, mFOLFOX6 (a combination of three chemotherapies known as Oxaliplatin, Leucovorin, and Fluorouracil) is a current treatment option. This study is testing an experimental medicine called zolbetuximab (IMAB362). Zolbetuximab attaches itself to Claudin 18.2 on the cancer cells causing cancer cell death. Patients will be assigned to one of two groups by chance and given either: - zolbetuximab with mFOLFOX6; or - a placebo with mFOLFOX6. A placebo is a treatment that looks like the experimental medicine, but contains no medicine. The goal of the study is to find out if zolbetuximab with mFOLFOX6 helps patients to live longer by stopping the cancer from getting worse.
Status | Active, not recruiting |
Enrollment | 566 |
Est. completion date | March 31, 2025 |
Est. primary completion date | September 9, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Female subject eligible to participate if she is not pregnant (negative serum pregnancy test at screening; female subjects with elevated serum beta human chorionic gonadotropin and a demonstrated non-pregnant status through additional testing are eligible) and at least one of the following conditions applies: - Not a woman of child-bearing potential (WOCBP) OR - WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs - Female subject must agree not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration. - Female subject must not donate ova starting at screening and throughout the study period, and for 9 months after the final administration of oxaliplatin and 6 months after the final administration of all other study drugs. - A sexually active male subject with a female partner(s) who is of child-bearing potential must agree to use contraception during the treatment period and for at least 6 months after the final study drug administration. - Male subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration. - Male subject with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final study drug administration. - Subject has histologically confirmed diagnosis of Gastric or GEJ adenocarcinoma. - Subject has radiologically confirmed locally advanced unresectable or metastatic disease within 28 days prior to randomization. - Subject has radiologically evaluable disease (measurable and/or non-measurable disease according to RECIST 1.1), per local assessment, = 28 days prior to randomization. For subjects with only 1 evaluable lesion and prior radiotherapy = 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy. - Subject's tumor expresses CLDN18.2 in = 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing. - Subject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen. (Unique to China: Subject has a known HER2-negative gastric or GEJ tumor.) - Subject has ECOG performance status 0 to 1. - Subject has predicted life expectancy = 12 weeks. - Subject must meet all of the following criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In the case of multiple sample collections within this period, the most recent sample collection with available results should be used to determine eligibility. - Hemoglobin (Hgb) = 9 g/dL. Subjects requiring transfusions are eligible if they have a post-transfusion Hgb = 9 g/dL. - Absolute neutrophil count (ANC) = 1.5 x 10^9/L - Platelets = 100 x 10^9/L - Albumin = 2.5 g/dL - Total bilirubin = 1.5 x upper limit of normal (ULN) without liver metastases (or < 3.0 x ULN if liver metastases are present) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x ULN without liver metastases (or = 5 x ULN if liver metastases are present) - Estimated creatinine clearance = 30 mL/min - Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) = 1.5 x ULN (except for subjects receiving anticoagulation therapy) Exclusion Criteria: - Subject has received prior systemic chemotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, subject may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies, as long as it was completed at least 6 months prior to randomization. Subject may have received treatment with herbal medications that have known antitumor activity > 28 days prior to randomization. - Subject has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma = 14 days prior to randomization and has not recovered from any related toxicity. - Subject has received systemic immunosuppressive therapy, including systemic corticosteroids within 14 days prior to randomization. Subjects using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed. - Subject has received other investigational agents or devices within 28 days prior to randomization. - Subject has prior severe allergic reaction or intolerance to known ingredients of zolbetuximab or other monoclonal antibodies, including humanized or chimeric antibodies. - Subject has known immediate or delayed hypersensitivity, intolerance or contraindication to any component of study treatment. - Subject has prior severe allergic reaction or intolerance to any component of mFOLFOX6. - Subject has known dihydropyrimidine dehydrogenase deficiency. - Subject has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting. - Subject has significant gastric bleeding and/or untreated gastric ulcers that would exclude the subject from participation. - Subject has a known history of a positive test for human immunodeficiency virus (HIV) infection or known active hepatitis B (positive hepatitis B surface antigen (HBs Ag)) or C infection. NOTE: Screening for these infections should be conducted per local requirements. - For subjects who are negative for HBs Ag, but hepatitis B core antibody (HBc Ab) positive, an HB deoxyribonucleic acid (DNA) test will be performed and if positive, the subject will be excluded. - Subjects with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test are eligible. - Subjects treated for HCV with undetectable viral load results are eligible. - Subject has an active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization. - Subject has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization. - Subject has significant cardiovascular disease, including any of the following: - Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident (CVA) or hypertensive crisis within 6 months prior to randomization. - History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes) - QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects - History or family history of congenital long QT syndrome - Cardiac arrhythmias requiring anti-arrhythmic medications (Subject with rate controlled atrial fibrillation for > 1 month prior to randomization are eligible). - Subject has a history of central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ cancer. - Subject has known peripheral sensory neuropathy > Grade 1 unless the absence of deep tendon reflexes is the sole neurological abnormality. - Subject has had a major surgical procedure = 28 days prior to randomization. - Subject is without complete recovery from a major surgical procedure = 14 days prior to randomization. - Subject has psychiatric illness or social situations that would preclude study compliance. - Subject has another malignancy for which treatment is required. - Subject has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data. |
Country | Name | City | State |
---|---|---|---|
Australia | Site AU61008 | Adelaide | South Australia |
Australia | Site AU61002 | Douglas | Queensland |
Australia | Site AU61006 | East Bentleigh | Victoria |
Australia | Site AU61007 | Kogarah | |
Australia | Site AU61011 | Tugun | Queensland |
Belgium | Site BE32005 | Brugge | |
Belgium | Site BE32004 | Brussels | |
Belgium | Site BE32001 | Bruxelles | Bruxelles-Capitale, Région De |
Belgium | Site BE32002 | Bruxelles | Liege |
Belgium | Site BE32011 | Charleroi | |
Belgium | Site BE32007 | Edegem | Antwerpen |
Belgium | Site BE32012 | Gent | Oost-Vlaanderen |
Belgium | Site BE32010 | Haine-Saint-Paul | |
Belgium | Site BE32006 | Leuven | Vlaams Brabant |
Belgium | Site BE32008 | Mons | Hainaut |
Brazil | Site BR55007 | Barretos | São Paulo |
Brazil | Site BR55017 | Belo Horizonte | |
Brazil | Site BR55010 | Brasília | Distrito Federal |
Brazil | Site BR55002 | Itajai | Santa Catarina |
Brazil | Site BR55006 | Lajeado | Rio Grande Do Sul |
Brazil | Site BR55016 | Passo Fundo | |
Brazil | Site BR55015 | Rio de Janeiro | |
Brazil | Site BR55018 | Santa Catarina | |
Brazil | Site BR55003 | Santo Andre | Sao Paulo |
Brazil | Site BR55005 | Sao Jose do Rio Preto | Sao Paulo |
Brazil | Site BR55004 | São Paulo | |
Brazil | Site BR55009 | São Paulo | |
Canada | Site CA15005 | Edmonton | Alberta |
Canada | Site CA15002 | Montreal | Quebec |
Canada | Site CA15008 | Montreal | Quebec |
Canada | Site CA15009 | Saint-John | New Brunswick |
Canada | Site CA15011 | Toronto | Ontario |
Chile | Site CL56003 | Providencia | Santiago |
Chile | Site CL56008 | Providencia | |
Chile | Site CL56005 | Santiago | |
Chile | Site CL56007 | Valdivia | |
China | Site CN86002 | Beijing | |
China | Site CN86009 | Beijing | |
China | Site CN86003 | Haerbin | Heilongjiang |
China | Site CN86004 | Hangzhou Shi | Zhejiang |
China | Site CN86005 | Hefei | |
China | Site CN86006 | Nanjing | Jiangsu |
China | Site CN86001 | Xiamen | |
China | Site CN86008 | Zhengzhou | |
Colombia | Site CO57009 | Bogota | DC |
Colombia | Site CO57001 | Cali | |
Colombia | Site CO57005 | Cali | Valle |
Colombia | Site CO57002 | Medellin | |
Colombia | Site CO57006 | Medellín | Antioquia |
Colombia | Site CO57007 | Monteria | Córdoba |
France | Site FR33008 | Besancon cedex | Franche-Comte |
France | Site FR33010 | Brest Cedex | Bretagne |
France | Site FR33103 | Creteil | |
France | Site FR33009 | Dijon | Bourgogne |
France | Site FR33003 | Lyon | Rhone |
France | Site FR33011 | Montpellier Cedex 5 | Languedoc-Roussillon |
France | Site FR33005 | Nice | Provence-Alpes-Côte-d'Azur |
France | Site FR33007 | Nice Cedex 2 | |
France | Site FR33002 | Paris cedex | Paris |
France | Site FR33006 | Poitiers | Vienne |
France | Site FR33001 | Rennes | Bretagne |
France | Site FR33104 | Saint Priest en Jarez | |
France | Site FR33101 | St Herblain | Pays-de-la-Loire |
Germany | Site DE49011 | Berlin | |
Germany | Site DE49012 | Berlin | |
Germany | Site DE49010 | Dresden | Sachsen |
Germany | Site DE49018 | Dresden | |
Germany | Site DE49021 | Halle | Sachsen-Anhalt |
Germany | Site DE49019 | Heilbronn | |
Germany | Site DE49004 | Leipzig | Sachsen |
Germany | Site DE49015 | Magdeburg | Sachsen-Anhalt |
Germany | Site DE49002 | Mainz | Rheinland-Pfalz |
Germany | Site DE49007 | Munchen | Bayern |
Germany | Site DE49008 | Munich | Bavaria |
Israel | Site IL97210 | HaDarom | |
Israel | Site IL97201 | Haifa | |
Israel | Site IL97209 | Holon | |
Israel | Site IL97202 | Jerusalem | |
Israel | Site IL97206 | Kfar Saba | HaMerkaz |
Israel | Site IL97203 | Tel Aviv | |
Italy | Site IT39013 | Ancona | |
Italy | Site IT39004 | Bergamo | |
Italy | Site IT39009 | Cremona | |
Italy | Site IT39011 | Meldola | Forli |
Italy | Site IT39006 | Milano | |
Italy | Site IT39008 | Milano | |
Italy | Site IT39021 | Modena | |
Italy | Site IT39020 | Monza | Lombardia |
Italy | Site IT39016 | Padova | |
Italy | Site IT39012 | Parma | |
Italy | Site IT39018 | Perugia | |
Italy | Site IT39003 | Piacenza | |
Italy | Site IT39019 | Pisa | |
Italy | Site IT39022 | Reggio Emilia | |
Italy | Site IT39015 | Roma | |
Italy | Site IT39026 | Terni | |
Italy | Site IT39024 | Turin TO | |
Italy | Site IT39023 | Vicenza | VI |
Japan | Site JP81013 | Bunkyo-ku | Tokyo |
Japan | Site JP81006 | Chuo-ku | Tokyo |
Japan | Site JP81005 | Fukuoka | |
Japan | Site JP81015 | Hidaka | Saitama |
Japan | Site JP81003 | Kashiwa | Chiba |
Japan | Site JP81010 | Kitaadachi-gun | Saitama |
Japan | Site JP81014 | Kobe | Hyogo |
Japan | Site JP81008 | Koto-ku | Tokyo |
Japan | Site JP81002 | Matsuyama | Ehime |
Japan | Site JP81009 | Nagoya | Aichi |
Japan | Site JP81004 | Osaka | |
Japan | Site JP81011 | Osaka | |
Japan | Site JP81007 | Sapporo | Hokkaido |
Japan | Site JP81001 | Suita | Osaka |
Japan | Site JP81012 | Sunto-gun | Shizuoka |
Korea, Republic of | Site KR82008 | Incheon | |
Korea, Republic of | Site KR82002 | Seongnam-si | Gyeonggi-do |
Korea, Republic of | Site KR82003 | Seoul | |
Korea, Republic of | Site KR82004 | Seoul | Seoul Teugbyeolsi |
Korea, Republic of | Site KR82005 | Seoul | |
Korea, Republic of | Site KR82006 | Seoul | |
Korea, Republic of | Site KR82007 | Seoul | |
Korea, Republic of | Site KR82009 | Suwon-si | Gyeonggido [Kyonggi-do] |
Mexico | Site MX52001 | Aguascalientes | |
Mexico | Site MX52007 | Ciudad de México | Distrito Federal |
Mexico | Site MX52003 | Distrito Federal | |
Mexico | Site MX52009 | Jalisco | |
Mexico | Site MX52002 | Mexico | Distrito Federal |
Mexico | Site MX52004 | Oaxaca | |
Mexico | Site MX52008 | San Luis De Potosi | |
Mexico | Site MX52010 | Veracruz, Ver | Veracruz |
Peru | Site PE51003 | Arequipa | |
Peru | Site PE51001 | Lima | |
Peru | Site PE51005 | Lima | |
Peru | Site PE51006 | Lima | |
Peru | Site PE51004 | San Isidro | Lima |
Poland | Site PL48002 | Brzozow | Podkarpackie |
Poland | Site PL48004 | Lublin | Lubuskie |
Poland | Site PL48007 | Ostroleka | Mazowieckie |
Poland | Site PL48009 | Warszawa | |
Poland | Site PL48005 | Wieliszew | Mazowieckie |
Spain | Site ES34011 | Alcorcon | Madrid |
Spain | Site ES34010 | Avila | Castilla Y Leon |
Spain | Site ES34013 | Badalona | Barcelona |
Spain | Site ES34005 | Barcelona | |
Spain | Site ES34015 | Barcelona | |
Spain | Site ES34016 | Barcelona | |
Spain | Site ES34019 | Burgos | |
Spain | Site ES34004 | Madrid | |
Spain | Site ES34008 | Madrid | |
Spain | Site ES34017 | Madrid | |
Spain | Site ES34003 | Murcia | |
Spain | Site ES34018 | Sevilla | |
Spain | Site ES34006 | Zaragoza | |
Taiwan | Site TW88604 | Kaohsiung | |
Taiwan | Site TW88608 | Kaohsiung | |
Taiwan | Site TW88605 | Kwei-Shan | Taoyuan |
Taiwan | Site TW88603 | Taichung | |
Taiwan | Site TW88607 | Tainan | |
Taiwan | Site TW88601 | Taipei | |
Taiwan | Site TW88606 | Taipei | |
United Kingdom | Site GB44003 | Aberdeen | Aberdeenshire |
United Kingdom | Site GB44103 | Cambridge | |
United Kingdom | Site GB44009 | Coventry | |
United Kingdom | Site GB44104 | Dundee | |
United Kingdom | Site GB44008 | Leeds | |
United Kingdom | Site GB44002 | London | |
United Kingdom | Site GB44004 | London | |
United Kingdom | Site GB44101 | London | London, City Of |
United Kingdom | Site GB44001 | Manchester | |
United Kingdom | Site GB44102 | Sutton | Surrey |
United States | MultiCare Regional Cancer Center - Gig Harbor | Auburn | Washington |
United States | University of Colorado | Aurora | Colorado |
United States | CBCC Global Research, Inc. at Comprehensive Blood and Cancer | Bakersfield | California |
United States | University of Maryland Medical Center(UMMC)Transplant Center | Baltimore | Maryland |
United States | Memorial Sloan Kettering Cancer Center | Basking Ridge | New Jersey |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Maryland Oncology Hematology | Brandywine | Maryland |
United States | Roswell Park Cancer Institute | Buffalo | New York |
United States | Northwestern University Medical Center | Chicago | Illinois |
United States | University of Chicago | Chicago | Illinois |
United States | The Ohio State University Medical Center | Columbus | Ohio |
United States | Memorial Sloan Kettering Cancer Center | Commack | New York |
United States | Karmanos Cancer Institute | Detroit | Michigan |
United States | City of Hope Nat'l Medical Center | Duarte | California |
United States | Inova Dwight and Martha Schar Cancer Institute | Fairfax | Virginia |
United States | St. Jude Hospital Yorba Linda | Fullerton | California |
United States | Memorial Sloan Kettering Cancer Center | Harrison | New York |
United States | Memorial Cancer Institute - West | Hollywood | Florida |
United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Pacific Shores Medical Group | Huntington Beach | California |
United States | Lancaster General Hospital | Lancaster | Pennsylvania |
United States | Loma Linda University | Loma Linda | California |
United States | The Angeles Clinic and Research Institute | Los Angeles | California |
United States | Norton Cancer Institute | Louisville | Kentucky |
United States | University of Miami | Miami | Florida |
United States | Memorial Sloan Kettering Cancer Center | Middletown | Connecticut |
United States | Precision Cancer Research -Dayton Physicians Network | Middletown | Ohio |
United States | Memorial Sloan Kettering Cancer Center | Montvale | New Jersey |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Mount Sinai School of Medicine | New York | New York |
United States | Cancer Treatment Centers of America, Atlanta | Newnan | Georgia |
United States | University of Oklahoma Health Science Center | Oklahoma City | Oklahoma |
United States | Orlando Health Inc | Orlando | Florida |
United States | Memorial Hospital West | Pembroke Pines | Florida |
United States | Cancer Treatment Centers of America, Philadelphia | Philadelphia | Pennsylvania |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | University of Arizona | Phoenix | Arizona |
United States | Earle A. Chiles Research Institute | Portland | Oregon |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Rhode Island Hospital-Lifespan Cancer Institute | Providence | Rhode Island |
United States | University of California Davis | Sacramento | California |
United States | Health Partners Institute | Saint Louis Park | Minnesota |
United States | Regions Hospital | Saint Paul | Minnesota |
United States | University of California - San Francisco | San Francisco | California |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
United States | Sanford Cancer Center | Sioux Falls | South Dakota |
United States | Stony Brook University Medical Center | Stony Brook | New York |
United States | The University of Arizona Medical Center | Tucson | Arizona |
United States | Memorial Sloan Kettering Cancer Center | Uniondale | New York |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Global Development, Inc. |
United States, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, France, Germany, Israel, Italy, Japan, Korea, Republic of, Mexico, Peru, Poland, Spain, Taiwan, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression Free Survival (PFS) | PFS is defined as the time from the date of randomization until the date of radiological progressive disease (per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 by Independent Review Committee (IRC)) or death from any cause, whichever is earliest. | Up to 13 months | |
Secondary | Overall Survival (OS) | OS is defined as the time from the date of randomization until the date of death from any cause. | Up to 23 months | |
Secondary | Objective Response Rate (ORR) | ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by Independent Review Committee (IRC) per RECIST 1.1. | Up to 13 months | |
Secondary | Duration Of Response (DOR) | DOR, defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by IRC per RECIST 1.1 or date of death from any cause, whichever is earliest. | Up to 13 months | |
Secondary | Safety and tolerability assessed by adverse events (AEs) | An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. | Up to 16 months | |
Secondary | Number of participants with laboratory assessments abnormalities and or adverse events | Number of participants with potentially clinically significant laboratory values. | Up to 14 months | |
Secondary | Number of participants with vital signs abnormalities and or adverse events | Number of participants with potentially clinically significant vital sign values. | Up to 14 months | |
Secondary | Number of participants with electrocardiograms (ECG) abnormalities and or adverse events | Number of participants with potentially clinically significant ECG values. | Up to 14 months | |
Secondary | Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events | Number of participants with potentially clinically significant ECOG performance status values. ECOG grades 0-5, where 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair and 5 = Dead. | Up to 13 months | |
Secondary | Health Related Quality of Life (HRQoL) measured by the European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30) questionnaire | The EORTC-QLQ-C30 is a cancer-specific instrument consisting of 5 functional domain scales: physical, role, emotional, social and cognitive. | Up to 16 months | |
Secondary | HRQoL measured by the QLQ-OG25 questionnaire | The EORTC-QLQ-OG25 instrument evaluates Gastric and GEJ cancer-specific symptoms such as stomach discomfort, difficulties eating and swallowing and indigestion. | Up to 16 months | |
Secondary | HRQoL measured by the Global Pain (GP) questionnaire | The GP instrument is a single assessment of overall pain. | Up to 16 months | |
Secondary | HRQoL measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) questionnaire | The EQ-5D-5L is a standardized instrument developed by the EuroQol Group for use as a generic, preference-based measure of health outcomes. The EQ-5D-5L is a 5-item self-reported measure of functioning and wellbeing, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, extreme problems). A unique EQ-5D-5L health state is defined by combining 1 level from each of the 5 dimensions. This questionnaire also records the respondent's self-rated health status on a vertical graduated (0 = the worst health a participant can imagine to 100 = the best health a participant can imagine) visual analogue scale. Responses to the 5 items will also be converted to a weighted health state index (utility score) based on values derived from general population samples. | Up to 16 months | |
Secondary | Time to confirmed deterioration (TTCD) | Calculated using the physical function (PF), OG25-Pain and Global Health Status (GHS)/QoL scores as measured by EORTC QLQ-C30 and QLQ-OG25. TTCD is defined as time to first confirmed deterioration (time from randomization to first clinically meaningful deterioration that is confirmed at the next scheduled visit). | Up to 16 months | |
Secondary | PK of zolbetuximab: Concentration Immediately Prior to Dosing at multiple dosing (Ctrough) | Ctrough will be derived from the PK serum samples collected. | Up to 16 months | |
Secondary | Number of anti-drug antibody (ADA) Positive Participants | Immunogenicity will be measured by the number of participants that are ADA positive. | Up to 16 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03653507 -
A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
|
Phase 3 | |
Available |
NCT06048081 -
Early Access Program for Zolbetuximab
|