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)

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Gastroesophageal Junction Cancer
• Intervention / Treatment: Drug: AZD0901; Drug: Ramucirumab+ paclitaxel; Drug: Paclitaxel; Drug: Docetaxel; Drug: Irinotecan; Drug: TAS-102; Drug: Apatinib; Drug: AZD0901

Detailed Description

This is a Phase III, multi-center, open-label, sponsor-blinded, randomized, global study to assess the efficacy and safety of AZD0901 compared to Investigator's choice of therapy as the 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2, and the clinical performance of the investigational IVD. As part of this combined approach, the efficacy analyses from this study will also provide the basis to evaluate the clinical performance of Ventana CLDN18.2 assay as an IVD device for the identification of patients with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2 who may benefit from AZD0901.

• Study Type: Interventional
• Enrollment (Estimated): 572
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Brazil
  • Porto Alegre, Brazil, 91350-200
    • Recruiting
    • Research Site
  • Ribeirão Preto, Brazil, 14051-140
    • Recruiting
    • Research Site
  • São Paulo, Brazil, 05652-900
    • Recruiting
    • Research Site
  • Vitória, Brazil, 29043-272
    • Recruiting
    • Research Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Withdrawn
      • Research Site
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Recruiting
      • Research Site
    • London, Ontario, Canada, N6C 2R5
      • Recruiting
      • Research Site
    • North York, Ontario, Canada, M2K 1E1
      • Recruiting
      • Research Site
    • Ottawa, Ontario, Canada, K1H 8L6
      • Recruiting
      • Research Site
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Withdrawn
      • Research Site
    • Montreal, Quebec, Canada, H3G 1A4
      • Recruiting
      • Research Site
• China
  • Beijing, China, 100210
    • Recruiting
    • Research Site
  • Changchun, China, 130021
    • Recruiting
    • Research Site
  • Changsha, China, 410013
    • Withdrawn
    • Research Site
  • Chengdu, China, 610000
    • Recruiting
    • Research Site
  • Chengdu, China, 610042
    • Recruiting
    • Research Site
  • Fuzhou, China, 350001
    • Recruiting
    • Research Site
  • Fuzhou, China, 350014
    • Recruiting
    • Research Site
  • Guangzhou, China, 510120
    • Recruiting
    • Research Site
  • Guangzhou, China, 510060
    • Recruiting
    • Research Site
  • Guangzhou, China, 510700
    • Recruiting
    • Research Site
  • Guangzhou, China, 510655
    • Recruiting
    • Research Site
  • Hangzhou, China, 310020
    • Recruiting
    • Research Site
  • Hangzhou, China, 310022
    • Recruiting
    • Research Site
  • Harbin, China, 150049
    • Recruiting
    • Research Site
  • Hefei, China, 230601
    • Recruiting
    • Research Site
  • Hefei, China, 230022
    • Recruiting
    • Research Site
  • Hefei, China, 230031
    • Recruiting
    • Research Site
  • Jinan, China, 250117
    • Recruiting
    • Research Site
  • Jining, China, 272029
    • Recruiting
    • Research Site
  • Lanzhou, China, 730000
    • Recruiting
    • Research Site
  • Lishui, China, 323000
    • Recruiting
    • Research Site
  • Luoyang, China, 471003
    • Withdrawn
    • Research Site
  • Nanjing, China, 210008
    • Recruiting
    • Research Site
  • Nanjing, China, 210009
    • Withdrawn
    • Research Site
  • Qingdao, China, 266003
    • Recruiting
    • Research Site
  • Shanghai, China, 200025
    • Recruiting
    • Research Site
  • Shanghai, China, 200032
    • Recruiting
    • Research Site
  • Shanghai, China, 200040
    • Recruiting
    • Research Site
  • Shenyang, China, 110042
    • Recruiting
    • Research Site
  • Shijiazhuang, China, 050011
    • Recruiting
    • Research Site
  • Suzhou, China, 215004
    • Recruiting
    • Research Site
  • Tianjin, China, 300060
    • Recruiting
    • Research Site
  • Wuhan, China, 430030
    • Recruiting
    • Research Site
  • Wuhan, China, 430000
    • Recruiting
    • Research Site
  • Xi'an, China, 710061
    • Recruiting
    • Research Site
  • Yinchuan, China, 750004
    • Recruiting
    • Research Site
  • Zhengzhou, China, 450003
    • Recruiting
    • Research Site
  • Ürümqi, China, 830000
    • Suspended
    • Research Site
• France
  • Besançon, France, 25030
    • Recruiting
    • Research Site
  • Brest, France, 29200
    • Active, not recruiting
    • Research Site
  • Lille, France, 59037
    • Recruiting
    • Research Site
  • Lyon, France, 69008
    • Active, not recruiting
    • Research Site
  • Nantes, France, 44000
    • Recruiting
    • Research Site
  • Paris, France, 75571
    • Recruiting
    • Research Site
  • Poitiers, France, 86021
    • Recruiting
    • Research Site
• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Research Site
  • Berlin, Germany, 10249
    • Recruiting
    • Research Site
  • Dresden, Germany, 01067
    • Withdrawn
    • Research Site
  • Dresden, Germany, 01370
    • Withdrawn
    • Research Site
  • Essen, Germany, 45136
    • Withdrawn
    • Research Site
  • Frankfurt, Germany, 60488
    • Recruiting
    • Research Site
  • Göttingen, Germany, 37075
    • Recruiting
    • Research Site
  • Hamburg, Germany, 20246
    • Recruiting
    • Research Site
  • Heidelberg, Germany, 69120
    • Recruiting
    • Research Site
  • Heilbronn, Germany, 74078
    • Recruiting
    • Research Site
  • Leipzig, Germany, 04103
    • Recruiting
    • Research Site
  • Mainz, Germany, 55131
    • Withdrawn
    • Research Site
  • Marburg, Germany, 35043
    • Recruiting
    • Research Site
  • Moers, Germany, 47441
    • Recruiting
    • Research Site
  • München, Germany, 81377
    • Recruiting
    • Research Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Research Site
  • Hong Kong, Hong Kong, 150001
    • Recruiting
    • Research Site
• India
  • Ahmedabad, India, 380015
    • Recruiting
    • Research Site
  • Bengaluru, India, 560027
    • Withdrawn
    • Research Site
  • Hyderabad, India, 500032
    • Recruiting
    • Research Site
  • Mumbai, India, 400012
    • Recruiting
    • Research Site
  • New Delhi, India, 110085
    • Recruiting
    • Research Site
• Italy
  • Florence, Italy, 50134
    • Recruiting
    • Research Site
  • Milan, Italy, 20133
    • Recruiting
    • Research Site
  • Milan, Italy, 20162
    • Recruiting
    • Research Site
  • Modena, Italy, 41124
    • Withdrawn
    • Research Site
  • Napoli, Italy, 80131
    • Recruiting
    • Research Site
  • Padua, Italy, 35128
    • Recruiting
    • Research Site
  • Pisa, Italy, 56100
    • Recruiting
    • Research Site
  • Vicenza, Italy, 36100
    • Recruiting
    • Research Site
• Japan
  • Fukuoka, Japan, 812-8582
    • Recruiting
    • Research Site
  • Kashiwa, Japan, 227-8577
    • Recruiting
    • Research Site
  • Kōtoku, Japan, 135-8550
    • Recruiting
    • Research Site
  • Nagoya, Japan, 464-8681
    • Recruiting
    • Research Site
  • Ogaki-shi, Japan, 503-8502
    • Recruiting
    • Research Site
  • Osaka, Japan, 541-8567
    • Recruiting
    • Research Site
  • Sunto-gun, Japan, 411-8777
    • Recruiting
    • Research Site
  • Tokyo, Japan, 104-0045
    • Recruiting
    • Research Site
  • Toyoake-shi, Japan, 470-1192
    • Recruiting
    • Research Site
  • Yokohama, Japan, 241-8515
    • Recruiting
    • Research Site
• Poland
  • Bielsko-Biala, Poland, 43-300
    • Recruiting
    • Research Site
  • Gdansk, Poland, 80-219
    • Recruiting
    • Research Site
  • Katowice, Poland, 40-514
    • Active, not recruiting
    • Research Site
  • Krakow, Poland, 31-501
    • Recruiting
    • Research Site
  • Lublin, Poland, 20-080
    • Recruiting
    • Research Site
  • Szczecin, Poland, 71-730
    • Withdrawn
    • Research Site
  • Słupsk, Poland, 76-200
    • Active, not recruiting
    • Research Site
  • Tomaszów Mazowiecki, Poland, 97-200
    • Withdrawn
    • Research Site
  • Warsaw, Poland, 02-034
    • Recruiting
    • Research Site
  • Warsaw, Poland, 04-141
    • Recruiting
    • Research Site
• South Korea
  • Gyeonggi-do, South Korea, 13620
    • Recruiting
    • Research Site
  • Seoul, South Korea, 03080
    • Recruiting
    • Research Site
  • Seoul, South Korea, 06351
    • Recruiting
    • Research Site
  • Seoul, South Korea, 03722
    • Recruiting
    • Research Site
  • Seoul, South Korea, 06591
    • Recruiting
    • Research Site
  • Seoul, South Korea, 05505
    • Active, not recruiting
    • Research Site
• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Research Site
  • Barcelona, Spain, 8035
    • Recruiting
    • Research Site
  • Madrid, Spain, 28034
    • Recruiting
    • Research Site
  • Madrid, Spain, 28041
    • Recruiting
    • Research Site
  • Ourense, Spain, 32005
    • Recruiting
    • Research Site
  • Santander, Spain, 39008
    • Recruiting
    • Research Site
  • Seville, Spain, 41013
    • Recruiting
    • Research Site
• Switzerland
  • Bern, Switzerland, 3010
    • Active, not recruiting
    • Research Site
  • Geneva, Switzerland, 1205
    • Active, not recruiting
    • Research Site
  • Lausanne, Switzerland, 1011
    • Active, not recruiting
    • Research Site
  • Zurich, Switzerland, 8032
    • Active, not recruiting
    • Research Site
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Recruiting
    • Research Site
  • Kaohsiung City, Taiwan, 00807
    • Recruiting
    • Research Site
  • Taichung, Taiwan, 40447
    • Recruiting
    • Research Site
  • Tainan, Taiwan, 704
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 10002
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 112
    • Recruiting
    • Research Site
  • Taoyuan District, Taiwan, 333
    • Recruiting
    • Research Site
• Thailand
  • Bangkok, Thailand, 10700
    • Active, not recruiting
    • Research Site
  • Dusit, Thailand, 10300
    • Active, not recruiting
    • Research Site
  • Hat Yai, Thailand, 90110
    • Active, not recruiting
    • Research Site
  • Khon Kaen, Thailand, 40002
    • Active, not recruiting
    • Research Site
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06230
    • Recruiting
    • Research Site
  • Diyarbakır, Turkey (Türkiye), 21280
    • Recruiting
    • Research Site
  • Erzurum, Turkey (Türkiye), 25240
    • Recruiting
    • Research Site
  • Istanbul, Turkey (Türkiye), 34098
    • Recruiting
    • Research Site
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Research Site
  • London, United Kingdom, EC1A 7BE
    • Recruiting
    • Research Site
  • London, United Kingdom, SW3 6JJ
    • Recruiting
    • Research Site
  • Manchester, United Kingdom, M20 4BX
    • Recruiting
    • Research Site
  • Oxford, United Kingdom, OX3 7LE
    • Recruiting
    • Research Site
  • Taunton, United Kingdom, TA1 5DA
    • Recruiting
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Withdrawn
      • Research Site
    • Mobile, Alabama, United States, 36604
      • Active, not recruiting
      • Research Site
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Active, not recruiting
      • Research Site
  • California
    • Duarte, California, United States, 91010
      • Active, not recruiting
      • Research Site
    • Fullerton, California, United States, 92835
      • Withdrawn
      • Research Site
    • Irvine, California, United States, 92618
      • Active, not recruiting
      • Research Site
    • Los Angeles, California, United States, 90089
      • Active, not recruiting
      • Research Site
    • Los Angeles, California, United States, 90048
      • Active, not recruiting
      • Research Site
    • Newport Beach, California, United States, 92663
      • Recruiting
      • Research Site
    • Santa Rosa, California, United States, 95403
      • Withdrawn
      • Research Site
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Active, not recruiting
      • Research Site
  • Florida
    • Fleming Island, Florida, United States, 32003
      • Withdrawn
      • Research Site
    • Hollywood, Florida, United States, 33021
      • Active, not recruiting
      • Research Site
    • Orlando, Florida, United States, 32804
      • Active, not recruiting
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Withdrawn
      • Research Site
    • Marietta, Georgia, United States, 30060
      • Active, not recruiting
      • Research Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96819
      • Withdrawn
      • Research Site
  • Idaho
    • Boise, Idaho, United States, 83712
      • Active, not recruiting
      • Research Site
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Active, not recruiting
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Withdrawn
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Active, not recruiting
      • Research Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Active, not recruiting
      • Research Site
    • Ann Arbor, Michigan, United States, 48106
      • Active, not recruiting
      • Research Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Active, not recruiting
      • Research Site
    • St Louis, Missouri, United States, 63110
      • Withdrawn
      • Research Site
    • St Louis, Missouri, United States, 63128
      • Withdrawn
      • Research Site
  • New York
    • Mineola, New York, United States, 11501
      • Active, not recruiting
      • Research Site
    • New York, New York, United States, 10065
      • Recruiting
      • Research Site
    • New York, New York, United States, 10016
      • Active, not recruiting
      • Research Site
    • New York, New York, United States, 10032
      • Active, not recruiting
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Withdrawn
      • Research Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • Withdrawn
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Active, not recruiting
      • Research Site
    • York, Pennsylvania, United States, 17403
      • Active, not recruiting
      • Research Site
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Active, not recruiting
      • Research Site
    • Fredericksburg, Virginia, United States, 22408
      • Active, not recruiting
      • Research Site
  • Washington
    • Olympia, Washington, United States, 98502
      • Active, not recruiting
      • Research Site
    • Seattle, Washington, United States, 98109
      • Withdrawn
      • Research Site
• Vietnam
  • Hanoi, Vietnam, 100000
    • Recruiting
    • Research Site
  • Ho Chi Minh City, Vietnam, 700000
    • Recruiting
    • Research Site
  • Vinh, Vietnam, 460000
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Capable of giving signed informed consent prior to any study procedure.
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:

1. 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.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AZD0901 arm 1; Participants in the AZD0901 arm 1 will receive AZD0901 dose level 1 intravenous infusion treatment.	Drug: AZD0901; Participants in the AZD0901 arm 1 will receive dose level 1 AZD0901 IV; Other Names: Sonesitatug Vedotin; Drug: AZD0901; Participants in the AZD0901 arm 2 will receive dose level 2 AZD0901 IV (Enrolment was closed); Other Names: Sonesitatug Vedotin
Active Comparator: 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.	Drug: 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; Drug: Paclitaxel; Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W (for participants with contraindication to ramucirumab only); Drug: Docetaxel; Docetaxel 75-100 mg/m2 IV on Day 1, Q3W (for participants with contraindication to ramucirumab only); Drug: Irinotecan; Irinotecan 150-180 mg/m2 IV on Days 1 and 15, Q4W; Drug: 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); Drug: Apatinib; Apatinib 500-850 mg at Investigator's discretion based on participant's condition and tolerability, orally once daily, Q4W (China only)
Experimental: AZD0901 Arm 2; Participants in the AZD0901 arm 2 will receive AZD0901 dose level 2 intravenous infusion treatment. (Enrolment was closed)	Drug: AZD0901; Participants in the AZD0901 arm 1 will receive dose level 1 AZD0901 IV; Other Names: Sonesitatug Vedotin; Drug: AZD0901; Participants in the AZD0901 arm 2 will receive dose level 2 AZD0901 IV (Enrolment was closed); Other Names: Sonesitatug Vedotin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS in all randomized participants	The analysis will include all randomized participants. 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).
PFS for 3L+ participants	The analysis will include all randomized participants who had at least 2 prior lines of systemic therapy. 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).
Objective Response Rate (ORR) in all randomized participants	ORR is defined as the proportion of participants with at least one visit response of confirmed CR or confirmed PR, as determined by BICR per RECIST 1.1.	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	The analysis will include all randomized participants who had at least 2 prior lines of systemic therapy, with measurable disease at baseline	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	The analysis will include all randomized participants with measurable disease at baseline who have a confirmed response. All events after achieving confirmed response will be included, regardless of whether the participant withdraws from therapy, receives another anticancer therapy or clinically progresses prior to RECIST 1.1.	From the date of first documented confirmed response until date of documented progression (approximately 3 years).
Serum concentrations of AZD0901, total antibody and MMAE	To characterise the PK of AZD0901 in participants.	From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation.
Status of ADA to AZD0901	To determine the immunogenicity of AZD0901 in participants.	From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]. Changes from baseline in vital signs, clinical laboratory results, and ECGs	To assess the safety and tolerability of AZD0901 as compared with Investigator's choice of therapy in all randomized participants who have received at least one dose of study intervention	From start through 30 days post treatment completion and follow up for 90 days.
PK parameters (such as peak concentration, as data allow) of AZD0901, total antibody and MMAE	To characterise the PK of AZD0901 in participants.	From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation.
PK parameters (such as trough concentration, as data allow) of AZD0901, total antibody and MMAE	To characterise the PK of AZD0901 in participants.	From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation.
Prevalence and incidence of ADA to AZD0901	To determine the immunogenicity of AZD0901 in participants.	From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation.
Titer of ADA to AZD0901	To determine the immunogenicity of AZD0901 in participants.	From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation.

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): May 14, 2026
• Study Completion (Estimated): September 14, 2026

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Gastric cancer; Phase III; Gastroesophageal junction cancer; Claudin 18.2; AZD0901
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Organic Chemicals; Heterocyclic Compounds; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Camptothecin; Alkaloids; Taxoids; Cyclodecanes; Diterpenes; Docetaxel; Irinotecan; Paclitaxel; trifluridine tipiracil drug combination; apatinib
• Other Study ID Numbers: D9802C00001; 2023-508276-11-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No