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
A Phase III Multi-center, Open-label, Sponsor-blinded, Randomized Study of AZD0901 Monotherapy Compared With Investigator's Choice of Therapy in Second- or Later-Line Adult Participants With Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 (CLARITY Gastric 01)
2 other identifiers
interventional
572
19 countries
186
Brief Summary
The purpose of this study is to measure the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 gastric-cancer
Started Mar 2024
Shorter than P25 for phase_3 gastric-cancer
186 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2024
CompletedStudy Start
First participant enrolled
March 4, 2024
CompletedFirst Posted
Study publicly available on registry
April 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 14, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 14, 2026
March 9, 2026
March 1, 2026
2.2 years
February 28, 2024
March 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression Free Survival (PFS) in all randomized participants
The analysis will include all randomized participants. All events will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy.
From date of first dose/randomisation until disease progression or death in the absence of progression (approximately 3 years).
Overall Survival (OS) for 3L+ participants
The analysis will include all randomized participants who had at least 2 prior lines of systemic therapy. All deaths will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy.
From date of first dose/randomisation until the date of death due to any cause (approximately 3 years).
Secondary Outcomes (12)
OS in all randomized participants
From date of first dose/randomisation until the date of death due to any cause (approximately 3 years).
PFS for 3L+ participants
From date of first dose/randomisation until disease progression or death in the absence of progression (approximately 3 years).
Objective Response Rate (ORR) in all randomized participants
From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 3 years).
ORR for 3L+ participants
From date of first dose of AZD0901 up until progression, or the last evaluable assessment in the absence of progression (approximately 3 years).
Duration of Response (DoR) in all randomized participants
From the date of first documented confirmed response until date of documented progression (approximately 3 years).
- +7 more secondary outcomes
Study Arms (3)
AZD0901 arm 1
EXPERIMENTALParticipants in the AZD0901 arm 1 will receive AZD0901 dose level 1 intravenous infusion treatment.
AZD0901 Arm 2
EXPERIMENTALParticipants in the AZD0901 arm 2 will receive AZD0901 dose level 2 intravenous infusion treatment. (Enrolment was closed)
Investigator's choice arm
ACTIVE COMPARATORParticipants in the Investigator's choice arm will receive a regimen of Investigator's choice, including regionally accepted chemotherapies or targeted therapies.
Interventions
Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W (for participants with contraindication to ramucirumab only)
Docetaxel 75-100 mg/m2 IV on Day 1, Q3W (for participants with contraindication to ramucirumab only)
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 500-850 mg at Investigator's discretion based on participant's condition and tolerability, orally once daily, Q4W (China only)
Participants in the AZD0901 arm 1 will receive dose level 1 AZD0901 IV
Ramucirumab 8 mg/kg IV on Days 1 and 15 and paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W
Eligibility Criteria
You may qualify if:
- Capable of giving signed informed consent prior to any study procedure.
- 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.
- 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.
- 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.
- Must have at least one measurable or evaluable lesion assessed by the Investigator based on RECIST 1.1.
- ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
- Predicted life expectancy of ≥ 12 weeks.
- Adequate organ and bone marrow function
- Body weight of ≥ 35 kg.
- Sex and Contraceptive Requirements
You may not qualify if:
- Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH + (Cases with HER2: CEP17 ratio ≥ 2 or an average HER2 copy number ≥ 6.0 signals/cell are considered positive by ISH). Participants must undergo local (or have had) HER2 testing by IHC/ISH, and the most recent result of HER2 status will be used to determine the eligibility.
- Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers.
- 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.
- Participant has known clinically significant corneal disease (eg, active keratitis or corneal ulcerations).
- 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).
- 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).
- History of thromboembolic events:
- 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
- History of arterial thromboembolism within the past 12 months prior to randomization
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (186)
Research Site
Birmingham, Alabama, 35233, United States
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Mobile, Alabama, 36604, United States
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Tucson, Arizona, 85719, United States
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Duarte, California, 91010, United States
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Fullerton, California, 92835, United States
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Irvine, California, 92618, United States
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Los Angeles, California, 90048, United States
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Los Angeles, California, 90089, United States
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Newport Beach, California, 92663, United States
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Santa Rosa, California, 95403, United States
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Washington D.C., District of Columbia, 20007, United States
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Fleming Island, Florida, 32003, United States
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Hollywood, Florida, 33021, United States
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Orlando, Florida, 32804, United States
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Atlanta, Georgia, 30322, United States
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Marietta, Georgia, 30060, United States
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Honolulu, Hawaii, 96819, United States
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Boise, Idaho, 83712, United States
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Lexington, Kentucky, 40536, United States
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Baltimore, Maryland, 21287, United States
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Boston, Massachusetts, 02114, United States
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Ann Arbor, Michigan, 48106, United States
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Ann Arbor, Michigan, 48109, United States
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Kansas City, Missouri, 64111, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63128, United States
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Mineola, New York, 11501, United States
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New York, New York, 10016, United States
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New York, New York, 10032, United States
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New York, New York, 10065, United States
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Cincinnati, Ohio, 45219, United States
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Portland, Oregon, 97239, United States
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Philadelphia, Pennsylvania, 19111, United States
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York, Pennsylvania, 17403, United States
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Charlottesville, Virginia, 22908, United States
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Fredericksburg, Virginia, 22408, United States
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Olympia, Washington, 98502, United States
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Seattle, Washington, 98109, United States
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Porto Alegre, 91350-200, Brazil
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Ribeirão Preto, 14051-140, Brazil
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São Paulo, 05652-900, Brazil
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Vitória, 29043-272, Brazil
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Calgary, Alberta, T2N 4N2, Canada
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Barrie, Ontario, L4M 6M2, Canada
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London, Ontario, N6C 2R5, Canada
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North York, Ontario, M2K 1E1, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Beijing, 100210, China
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Changchun, 130021, China
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Changsha, 410013, China
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Chengdu, 610000, China
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Chengdu, 610042, China
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Fuzhou, 350001, China
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Fuzhou, 350014, China
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Guangzhou, 510060, China
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Guangzhou, 510120, China
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Guangzhou, 510655, China
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Guangzhou, 510700, China
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Hangzhou, 310020, China
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Hangzhou, 310022, China
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Harbin, 150049, China
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Hefei, 230022, China
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Hefei, 230031, China
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Hefei, 230601, China
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Jinan, 250117, China
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Jining, 272029, China
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Lanzhou, 730000, China
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Lishui, 323000, China
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Luoyang, 471003, China
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Nanjing, 210008, China
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Nanjing, 210009, China
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Qingdao, 266003, China
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Shanghai, 200025, China
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Shanghai, 200032, China
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Shanghai, 200040, China
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Shenyang, 110042, China
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Shijiazhuang, 050011, China
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Suzhou, 215004, China
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Tianjin, 300060, China
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Ürümqi, 830000, China
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Wuhan, 430000, China
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Wuhan, 430030, China
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Xi'an, 710061, China
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Yinchuan, 750004, China
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Zhengzhou, 450003, China
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Besançon, 25030, France
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Brest, 29200, France
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Lille, 59037, France
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Lyon, 69008, France
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Nantes, 44000, France
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Paris, 75571, France
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Poitiers, 86021, France
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Berlin, 10249, Germany
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Berlin, 13353, Germany
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Dresden, 01067, Germany
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Dresden, 01370, Germany
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Essen, 45136, Germany
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Frankfurt, 60488, Germany
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Göttingen, 37075, Germany
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Hamburg, 20246, Germany
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Heidelberg, 69120, Germany
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Heilbronn, 74078, Germany
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Leipzig, 04103, Germany
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Mainz, 55131, Germany
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Marburg, 35043, Germany
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Moers, 47441, Germany
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München, 81377, Germany
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Hong Kong, 150001, Hong Kong
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Hong Kong, Hong Kong
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Ahmedabad, 380015, India
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Bengaluru, 560027, India
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Hyderabad, 500032, India
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Mumbai, 400012, India
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New Delhi, 110085, India
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Florence, 50134, Italy
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Milan, 20133, Italy
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Milan, 20162, Italy
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Modena, 41124, Italy
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Naples, 80131, Italy
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Padua, 35128, Italy
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Pisa, 56100, Italy
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Vicenza, 36100, Italy
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Fukuoka, 812-8582, Japan
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Kashiwa, 227-8577, Japan
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Kōtoku, 135-8550, Japan
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Nagoya, 464-8681, Japan
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Ogaki-shi, 503-8502, Japan
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Osaka, 541-8567, Japan
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Sunto-gun, 411-8777, Japan
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Tokyo, 104-0045, Japan
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Toyoake-shi, 470-1192, Japan
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Yokohama, 241-8515, Japan
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Bielsko-Biala, 43-300, Poland
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Gdansk, 80-219, Poland
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Katowice, 40-514, Poland
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Krakow, 31-501, Poland
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Lublin, 20-080, Poland
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Szczecin, 71-730, Poland
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Słupsk, 76-200, Poland
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Tomaszów Mazowiecki, 97-200, Poland
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Warsaw, 02-034, Poland
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Warsaw, 04-141, Poland
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Gyeonggi-do, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06351, South Korea
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Seoul, 06591, South Korea
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Barcelona, 08036, Spain
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Barcelona, 8035, Spain
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Madrid, 28034, Spain
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Madrid, 28041, Spain
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Ourense, 32005, Spain
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Santander, 39008, Spain
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Seville, 41013, Spain
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Bern, 3010, Switzerland
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Geneva, 1205, Switzerland
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Lausanne, 1011, Switzerland
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Zurich, 8032, Switzerland
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Kaohsiung City, 00807, Taiwan
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Kaohsiung City, 83301, Taiwan
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Taichung, 40447, Taiwan
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Tainan, 704, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 112, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, 10700, Thailand
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Dusit, 10300, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40002, Thailand
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Ankara, 06230, Turkey (Türkiye)
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Diyarbakır, 21280, Turkey (Türkiye)
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Erzurum, 25240, Turkey (Türkiye)
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Istanbul, 34098, Turkey (Türkiye)
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Cambridge, CB2 0QQ, United Kingdom
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London, EC1A 7BE, United Kingdom
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London, SW3 6JJ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Oxford, OX3 7LE, United Kingdom
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Taunton, TA1 5DA, United Kingdom
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
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Vinh, 460000, Vietnam
Related Publications (1)
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.
PMID: 39232496DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- This is an open-label study; however, it will be conducted 'sponsor-blind' and the specific treatment to be taken by a participant will be assigned using an IRT/RTSM. To maintain the integrity of the study, sponsor access to treatment records will be restricted, and, in particular, under no circumstances will the sponsor undertake any efficacy analysis by treatment arm during the study. A Study Integrity Plan will be generated in which nominated individuals who will be granted access to any treatment-revealing data will be pre-specified, with their reason for requiring access detailed.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2024
First Posted
April 4, 2024
Study Start
March 4, 2024
Primary Completion (Estimated)
May 14, 2026
Study Completion (Estimated)
September 14, 2026
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.