AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2
NCT ID: NCT06346392
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
572 participants
INTERVENTIONAL
2024-03-04
2026-09-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
Arm 1: AZD0901 arm 1 IV, Q3W Arm 2: AZD0901 arm 2 IV, Q3W (Enrolment was closed) Arm 3: Participants in the Investigator's choice arm, including regionally accepted chemotherapies or targeted therapies 2L: Ramucirumab 8 mg/kg IV on Days 1 and 15 and paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W 2L: Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W (for participants with contraindication to ramucirumab only) 2L: Docetaxel 75-100 mg/m2 IV on Day 1, Q3W (for participants with contraindication to ramucirumab only) 3L+: Irinotecan 150-180 mg/m2 IV on Days 1 and 15, Q4W 3L+: TAS-102 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (except China) 3L+: Apatinib 500-850 mg, orally once daily, Q4W (China only)
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AZD0901 arm 1
Participants in the AZD0901 arm 1 will receive AZD0901 dose level 1 intravenous infusion treatment.
AZD0901
Participants in the AZD0901 arm 1 will receive dose level 1 AZD0901 IV
AZD0901 Arm 2
Participants in the AZD0901 arm 2 will receive AZD0901 dose level 2 intravenous infusion treatment. (Enrolment was closed)
AZD0901
Participants in the AZD0901 arm 2 will receive dose level 2 AZD0901 IV (Enrolment was closed)
Investigator's choice arm
Participants in the Investigator's choice arm will receive a regimen of Investigator's choice, including regionally accepted chemotherapies or targeted therapies.
Ramucirumab+ paclitaxel
Ramucirumab 8 mg/kg IV on Days 1 and 15 and paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W
Paclitaxel
Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W (for participants with contraindication to ramucirumab only)
Docetaxel
Docetaxel 75-100 mg/m2 IV on Day 1, Q3W (for participants with contraindication to ramucirumab only)
Irinotecan
Irinotecan 150-180 mg/m2 IV on Days 1 and 15, Q4W
TAS-102
TAS-102 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (except China)
Apatinib
Apatinib 500-850 mg at Investigator's discretion based on participant's condition and tolerability, orally once daily, Q4W (China only)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AZD0901
Participants in the AZD0901 arm 1 will receive dose level 1 AZD0901 IV
AZD0901
Participants in the AZD0901 arm 2 will receive dose level 2 AZD0901 IV (Enrolment was closed)
Ramucirumab+ paclitaxel
Ramucirumab 8 mg/kg IV on Days 1 and 15 and paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W
Paclitaxel
Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W (for participants with contraindication to ramucirumab only)
Docetaxel
Docetaxel 75-100 mg/m2 IV on Day 1, Q3W (for participants with contraindication to ramucirumab only)
Irinotecan
Irinotecan 150-180 mg/m2 IV on Days 1 and 15, Q4W
TAS-102
TAS-102 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (except China)
Apatinib
Apatinib 500-850 mg at Investigator's discretion based on participant's condition and tolerability, orally once daily, Q4W (China only)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Participant must be at least 18 years or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the ICF.
3. Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus (distal third of the esophagus) and the following requirement:
(a) Participants with positive CLDN18.2 expression from archival tumor collected within past 24 months or from a fresh biopsy.
4. Disease progression on or after at least one prior line of treatment (LoT) for advanced or metastatic disease, which included a fluoropyrimidine and a platinum, for advanced or metastatic disease.
5. Must have at least one measurable or evaluable lesion assessed by the Investigator based on RECIST 1.1.
6. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
7. Predicted life expectancy of ≥ 12 weeks.
8. Adequate organ and bone marrow function
9. Body weight of ≥ 35 kg.
10. Sex and Contraceptive Requirements
Exclusion Criteria
2. Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers.
3. CNS metastases or CNS pathology including: epilepsy, seizures or aphasia within 3 months prior to consent, severe brain injury, dementia, Parkinson's disease, neurodegenerative diseases, cerebellar disease, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases.
4. Participant has known clinically significant corneal disease (eg, active keratitis or corneal ulcerations).
5. Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss).
6. Prior exposure to any ADC with MMAE payload or any CLDN18.2 targeting treatment other than naked monoclonal antibody (eg, CLDN18.2 targeting CAR-T cell therapy, multi-specific antibody including targeting CLDN18.2, etc).
7. History of thromboembolic events:
1. Participants with venous thromboembolism within the past 6 months prior to randomization: participants with venous port or catheter thrombosis or superficial venous thrombus that do not require treatment or are stable on treatment with anticoagulants are excepted
2. History of arterial thromboembolism within the past 12 months prior to randomization
8. As judged by the Investigator, any evidence of diseases which in the Investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
18 Years
130 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Birmingham, Alabama, United States
Research Site
Mobile, Alabama, United States
Research Site
Tucson, Arizona, United States
Research Site
Duarte, California, United States
Research Site
Fullerton, California, United States
Research Site
Irvine, California, United States
Research Site
Los Angeles, California, United States
Research Site
Los Angeles, California, United States
Research Site
Newport Beach, California, United States
Research Site
Santa Rosa, California, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Fleming Island, Florida, United States
Research Site
Hollywood, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Marietta, Georgia, United States
Research Site
Honolulu, Hawaii, United States
Research Site
Boise, Idaho, United States
Research Site
Lexington, Kentucky, United States
Research Site
Baltimore, Maryland, United States
Research Site
Boston, Massachusetts, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Ann Arbor, Michigan, United States
Research Site
Kansas City, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
St Louis, Missouri, United States
Research Site
Mineola, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
New York, New York, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Philadelphia, Pennsylvania, United States
Research Site
York, Pennsylvania, United States
Research Site
Charlottesville, Virginia, United States
Research Site
Fredericksburg, Virginia, United States
Research Site
Olympia, Washington, United States
Research Site
Seattle, Washington, United States
Research Site
Porto Alegre, , Brazil
Research Site
Ribeirão Preto, , Brazil
Research Site
São Paulo, , Brazil
Research Site
Vitória, , Brazil
Research Site
Calgary, Alberta, Canada
Research Site
Barrie, Ontario, Canada
Research Site
London, Ontario, Canada
Research Site
North York, Ontario, Canada
Research Site
Ottawa, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Beijing, , China
Research Site
Changchun, , China
Research Site
Changsha, , China
Research Site
Chengdu, , China
Research Site
Chengdu, , China
Research Site
Fuzhou, , China
Research Site
Fuzhou, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Guangzhou, , China
Research Site
Hangzhou, , China
Research Site
Hangzhou, , China
Research Site
Harbin, , China
Research Site
Hefei, , China
Research Site
Hefei, , China
Research Site
Hefei, , China
Research Site
Jinan, , China
Research Site
Jining, , China
Research Site
Lanzhou, , China
Research Site
Lishui, , China
Research Site
Luoyang, , China
Research Site
Nanjing, , China
Research Site
Nanjing, , China
Research Site
Qingdao, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shenyang, , China
Research Site
Shijiazhuang, , China
Research Site
Suzhou, , China
Research Site
Tianjin, , China
Research Site
Ürümqi, , China
Research Site
Wuhan, , China
Research Site
Wuhan, , China
Research Site
Xi'an, , China
Research Site
Yinchuan, , China
Research Site
Zhengzhou, , China
Research Site
Besançon, , France
Research Site
Brest, , France
Research Site
Lille, , France
Research Site
Lyon, , France
Research Site
Nantes, , France
Research Site
Paris, , France
Research Site
Poitiers, , France
Research Site
Berlin, , Germany
Research Site
Berlin, , Germany
Research Site
Dresden, , Germany
Research Site
Dresden, , Germany
Research Site
Essen, , Germany
Research Site
Frankfurt, , Germany
Research Site
Göttingen, , Germany
Research Site
Hamburg, , Germany
Research Site
Heidelberg, , Germany
Research Site
Heilbronn, , Germany
Research Site
Leipzig, , Germany
Research Site
Mainz, , Germany
Research Site
Marburg, , Germany
Research Site
Moers, , Germany
Research Site
München, , Germany
Research Site
Hong Kong, , Hong Kong
Research Site
Hong Kong, , Hong Kong
Research Site
Ahmedabad, , India
Research Site
Bengaluru, , India
Research Site
Hyderabad, , India
Research Site
Mumbai, , India
Research Site
New Delhi, , India
Research Site
Florence, , Italy
Research Site
Milan, , Italy
Research Site
Milan, , Italy
Research Site
Modena, , Italy
Research Site
Napoli, , Italy
Research Site
Padua, , Italy
Research Site
Pisa, , Italy
Research Site
Vicenza, , Italy
Research Site
Fukuoka, , Japan
Research Site
Kashiwa, , Japan
Research Site
Kōtoku, , Japan
Research Site
Nagoya, , Japan
Research Site
Ogaki-shi, , Japan
Research Site
Osaka, , Japan
Research Site
Sunto-gun, , Japan
Research Site
Tokyo, , Japan
Research Site
Toyoake-shi, , Japan
Research Site
Yokohama, , Japan
Research Site
Bielsko-Biala, , Poland
Research Site
Gdansk, , Poland
Research Site
Katowice, , Poland
Research Site
Krakow, , Poland
Research Site
Lublin, , Poland
Research Site
Szczecin, , Poland
Research Site
Słupsk, , Poland
Research Site
Tomaszów Mazowiecki, , Poland
Research Site
Warsaw, , Poland
Research Site
Warsaw, , Poland
Research Site
Gyeonggi-do, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Madrid, , Spain
Research Site
Ourense, , Spain
Research Site
Santander, , Spain
Research Site
Seville, , Spain
Research Site
Bern, , Switzerland
Research Site
Geneva, , Switzerland
Research Site
Lausanne, , Switzerland
Research Site
Zurich, , Switzerland
Research Site
Kaohsiung City, , Taiwan
Research Site
Kaohsiung City, , Taiwan
Research Site
Taichung, , Taiwan
Research Site
Tainan, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taipei, , Taiwan
Research Site
Taoyuan District, , Taiwan
Research Site
Bangkok, , Thailand
Research Site
Dusit, , Thailand
Research Site
Hat Yai, , Thailand
Research Site
Khon Kaen, , Thailand
Research Site
Ankara, , Turkey (Türkiye)
Research Site
Diyarbakır, , Turkey (Türkiye)
Research Site
Erzurum, , Turkey (Türkiye)
Research Site
Istanbul, , Turkey (Türkiye)
Research Site
Cambridge, , United Kingdom
Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Oxford, , United Kingdom
Research Site
Taunton, , United Kingdom
Research Site
Hanoi, , Vietnam
Research Site
Ho Chi Minh City, , Vietnam
Research Site
Vinh, , Vietnam
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
References
Explore related publications, articles, or registry entries linked to this study.
Xu G, Liu W, Wang Y, Wei X, Liu F, He Y, Zhang L, Song Q, Li Z, Wang C, Xu R, Chen B. CMG901, a Claudin18.2-specific antibody-drug conjugate, for the treatment of solid tumors. Cell Rep Med. 2024 Sep 17;5(9):101710. doi: 10.1016/j.xcrm.2024.101710. Epub 2024 Sep 3.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-508276-11-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D9802C00001
Identifier Type: -
Identifier Source: org_study_id