Gastric CancerPhase 3NCT06346392

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 3 study testing AZD0901, Ramucirumab+ paclitaxel and Paclitaxel in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by AstraZeneca at 158 sites in 19 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Gastric Cancer, Gastroesophageal Junction Cancer
What is being tested?: AZD0901, Ramucirumab+ paclitaxel and Paclitaxel
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 594 participants
Where: 158 sitesin 19 countries
Study dates: 4 Mar 2024to 14 Oct 2026
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:
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.

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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

Who cannot join

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).

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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.

Trial locations and contacts

158 sites in 19 countries.

Country

City, postcode or hospital

158 sites in 19 countries

China35 sites

Research Site
Beijing, 100210
Research Site
Changchun, 130021
Research Site
Chengdu, 610000
Research Site
Chengdu, 610042
Research Site
Fuzhou, 350001
Research Site
Fuzhou, 350014
Research Site
Guangzhou, 510060
Research Site
Guangzhou, 510120
Research Site
Guangzhou, 510655
Research Site
Guangzhou, 510700
Research Site
Hangzhou, 310020
Research Site
Hangzhou, 310022
Research Site
Harbin, 150049
Research Site
Hefei, 230022
Research Site
Hefei, 230031
Research Site
Hefei, 230601
Research Site
Jinan, 250117
Research Site
Jining, 272029
Research Site
Lanzhou, 730000
Research Site
Lishui, 323000
Research Site
Nanjing, 210008
Research Site
Qingdao, 266034
Research Site
Shanghai, 200025
Research Site
Shanghai, 200032
Research Site
Shanghai, 200040
Research Site
Shenyang, 110042
Research Site
Shijiazhuang, 050011
Research Site
Suzhou, 215004
Research Site
Tianjin, 300060
Research Site
Ürümqi, 830000
Research Site
Wuhan, 430000
Research Site
Wuhan, 430030
Research Site
Xi'an, 710061
Research Site
Yinchuan, 750004
Research Site
Zhengzhou, 450003

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United States26 sites

Research Site
Ann Arbor, Michigan, 48106
Research Site
Ann Arbor, Michigan, 48109
Research Site
Boise, Idaho, 83712
Research Site
Boston, Massachusetts, 02114
Research Site
Charlottesville, Virginia, 22908
Research Site
Duarte, California, 91010
Research Site
Fredericksburg, Virginia, 22408
Research Site
Hollywood, Florida, 33021
Research Site
Irvine, California, 92618
Research Site
Kansas City, Missouri, 64111
Research Site
Lexington, Kentucky, 40536
Research Site
Los Angeles, California, 90048
Research Site
Los Angeles, California, 90089
Research Site
Marietta, Georgia, 30060
Research Site
Mineola, New York, 11501
Research Site
Mobile, Alabama, 36604
Research Site
New York, New York, 10016
Research Site
New York, New York, 10032
Research Site
New York, New York, 10065
Research Site
Newport Beach, California, 92663
Research Site
Olympia, Washington, 98502
Research Site
Orlando, Florida, 32804
Research Site
Philadelphia, Pennsylvania, 19111
Research Site
Tucson, Arizona, 85719
Research Site
Washington D.C., District of Columbia, 20007
Research Site
York, Pennsylvania, 17403

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Germany11 sites

Research Site
Berlin, 10249
Research Site
Berlin, 13353
Research Site
Frankfurt, 60488
Research Site
Göttingen, 37075
Research Site
Hamburg, 20246
Research Site
Heidelberg, 69120
Research Site
Heilbronn, 74078
Research Site
Leipzig, 04103
Research Site
Marburg, 35043
Research Site
Moers, 47441
Research Site
München, 81377

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Japan10 sites

Research Site
Fukuoka, 812-8582
Research Site
Kashiwa, 227-8577
Research Site
Kōtoku, 135-8550
Research Site
Nagoya, 464-8681
Research Site
Ogaki-shi, 503-8502
Research Site
Osaka, 541-8567
Research Site
Sunto-gun, 411-8777
Research Site
Tokyo, 104-0045
Research Site
Toyoake-shi, 470-1192
Research Site
Yokohama, 241-8515

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Poland8 sites

Research Site
Bielsko-Biala, 43-300
Research Site
Gdansk, 80-219
Research Site
Katowice, 40-514
Research Site
Krakow, 31-501
Research Site
Lublin, 20-080
Research Site
Słupsk, 76-200
Research Site
Warsaw, 02-034
Research Site
Warsaw, 04-141

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Italy7 sites

Research Site
Florence, 50134
Research Site
Milan, 20133
Research Site
Milan, 20162
Research Site
Naples, 80131
Research Site
Padova, 35128
Research Site
Pisa, 56100
Research Site
Vicenza, 36100

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Spain7 sites

Research Site
Barcelona, 08036
Research Site
Barcelona, 8035
Research Site
Madrid, 28034
Research Site
Madrid, 28041
Research Site
Ourense, 32005
Research Site
Santander, 39008
Research Site
Seville, 41013

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Taiwan7 sites

Research Site
Kaohsiung City, 00807
Research Site
Kaohsiung City, 83301
Research Site
Taichung, 40447
Research Site
Tainan, 704
Research Site
Taipei, 10002
Research Site
Taipei, 112
Research Site
Taoyuan, 333

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Canada6 sites

Research Site
Barrie, Ontario, L4M 6M2
Research Site
London, Ontario, N6C 2R5
Research Site
Montreal, Quebec, H3G 1A4
Research Site
North York, Ontario, M2K 1E1
Research Site
Ottawa, Ontario, K1H 8L6
Research Site
Toronto, Ontario, M5G 2M9

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South Korea6 sites

Research Site
Gyeonggi-do, 13620
Research Site
Seoul, 03080
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Seoul, 06351
Research Site
Seoul, 06591

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United Kingdom6 sites

Research Site
Cambridge, CB2 0QQ
Research Site
London, EC1A 7BE
Research Site
London, SW3 6JJ
Research Site
Manchester, M20 4BX
Research Site
Oxford, OX3 7LE
Research Site
Taunton, TA1 5DA

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France5 sites

Research Site
Besançon, 25030
Research Site
Brest, 29200
Research Site
Lille, 59037
Research Site
Lyon, 69008
Research Site
Nantes, 44000

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India4 sites

Research Site
Ahmedabad, 380015
Research Site
Hyderabad, 500032
Research Site
Mumbai, 400012
Research Site
New Delhi, 110085

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Switzerland4 sites

Research Site
Bern, 3010
Research Site
Geneva, 1205
Research Site
Lausanne, 1011
Research Site
Zurich, 8032

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Thailand4 sites

Research Site
Bangkok, 10700
Research Site
Dusit, 10300
Research Site
Hat Yai, 90110
Research Site
Khon Kaen, 40002

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Turkey (Türkiye)4 sites

Research Site
Ankara, 06230
Research Site
Diyarbakır, 21280
Research Site
Erzurum, 25240
Research Site
Istanbul, 34098

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Brazil3 sites

Research Site
Ribeirão Preto, 14051-140
Research Site
São Paulo, 05652-900
Research Site
Vitória, 29043-272

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Vietnam3 sites

Research Site
Hanoi, 100000
Research Site
Ho Chi Minh City, 700000
Research Site
Vinh, 460000

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Hong Kong2 sites

Research Site
Hong Kong, 150001
Research Site
Hong Kong, 999077

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About this study

Official title: 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)

Read the 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.

Conditions: Gastric Cancer, Gastroesophageal Junction Cancer
Being tested: AZD0901, Ramucirumab+ paclitaxel, Paclitaxel, Docetaxel, Irinotecan
Keywords: Gastric cancer, Gastroesophageal junction cancer, Phase III, Claudin 18.2, AZD0901
Medical subject headings: Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD0901Drug
Also called Sonesitatug Vedotin
Participants in the AZD0901 arm 1 will receive dose level 1 AZD0901 IV
AZD0901Drug
Also called Sonesitatug Vedotin
Participants in the AZD0901 arm 2 will receive dose level 2 AZD0901 IV (Enrolment was closed)
Ramucirumab+ paclitaxelDrug
Ramucirumab 8 mg/kg IV on Days 1 and 15 and paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W
PaclitaxelDrug
Paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W (for participants with contraindication to ramucirumab only)
DocetaxelDrug
Docetaxel 75-100 mg/m2 IV on Day 1, Q3W (for participants with contraindication to ramucirumab only)
IrinotecanDrug
Irinotecan 150-180 mg/m2 IV on Days 1 and 15, Q4W
TAS-102Drug
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)
ApatinibDrug
Apatinib 500-850 mg at Investigator's discretion based on participant's condition and tolerability, orally once daily, Q4W (China only)

Study groups in NCT06346392
Study group	Role	What they receive
AZD0901 arm 1	Experimental	Participants in the AZD0901 arm 1 will receive AZD0901 dose level 1 intravenous infusion treatment. Receives: Drug: AZD0901
AZD0901 Arm 2	Experimental	Participants in the AZD0901 arm 2 will receive AZD0901 dose level 2 intravenous infusion treatment. (Enrolment was closed) Receives: Drug: AZD0901
Investigator's choice arm	Active comparator	Participants in the Investigator's choice arm will receive a regimen of Investigator's choice, including regionally accepted chemotherapies or targeted therapies. Receives: Drug: Ramucirumab+ paclitaxel; Drug: Paclitaxel; Drug: Docetaxel; Drug: Irinotecan; Drug: TAS-102; Drug: Apatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Mar 202414 Oct 2026

First posted4 Apr 2024
Study start4 Mar 2024
Primary completion31 May 2026
Study completion14 Oct 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Gastric CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants were randomized in a 1:1:1 ratio to one of the following intervention arms until the dose selection decision was made. Randomization will continue in a 1:1 ratio to the 2 remaining arms: 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)
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 594 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06346392
Sponsor's protocol ID: D9802C00001
Other IDs: 2023-508276-11-00, 2023
Status last verified: Oct 2026
First submitted: 28 Feb 2024
Last updated: 15 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

Yu J, Mehta R. Biomarker-Driven Approach to the Treatment of Metastatic Gastric or Gastroesophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257036. doi: 10.6004/jnccn.2025.7036.
PubMed 40341124
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.
PubMed 39232496

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT06346392
Acronym / sponsor ID: D9802C00001
Conditions: Gastric Cancer, Gastroesophageal Junction Cancer
Keywords: Gastric cancer, Gastroesophageal junction cancer, Phase III, Claudin 18.2, AZD0901
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 594 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 4 Mar 2024 (actual)
Primary completion: 31 May 2026 (actual)
Study completion: 14 Oct 2026 (estimated)
First posted: 4 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: Participants were randomized in a 1:1:1 ratio to one of the following intervention arms until the dose selection decision was made. Randomization will continue in a 1:1 ratio to the 2 remaining arms: 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)

Arm	Type	Receives
AZD0901 arm 1	Experimental	Drug: AZD0901Participants in the AZD0901 arm 1 will receive AZD0901 dose level 1 intravenous infusion treatment.
AZD0901 Arm 2	Experimental	Drug: AZD0901Participants in the AZD0901 arm 2 will receive AZD0901 dose level 2 intravenous infusion treatment. (Enrolment was closed)
Investigator's choice arm	Active comparator	Drug: Ramucirumab+ paclitaxel, Drug: Paclitaxel, Drug: Docetaxel, Drug: Irinotecan, Drug: TAS-102, Drug: ApatinibParticipants in the Investigator's choice arm will receive a regimen of Investigator's choice, including regionally accepted chemotherapies or targeted therapies.

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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:
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.

Key exclusion criteria (10 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD0901Also: Sonesitatug VedotinParticipants in the AZD0901 arm 1 will receive dose level 1 AZD0901 IV	Drug	AZD0901 arm 1
AZD0901Also: Sonesitatug VedotinParticipants in the AZD0901 arm 2 will receive dose level 2 AZD0901 IV (Enrolment was closed)	Drug	AZD0901 Arm 2
Ramucirumab+ paclitaxelRamucirumab 8 mg/kg IV on Days 1 and 15 and paclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W	Drug	Investigator's choice arm
PaclitaxelPaclitaxel 80 mg/m2 IV on Days 1, 8, and 15, Q4W (for participants with contraindication to ramucirumab only)	Drug	Investigator's choice arm
DocetaxelDocetaxel 75-100 mg/m2 IV on Day 1, Q3W (for participants with contraindication to ramucirumab only)	Drug	Investigator's choice arm
IrinotecanIrinotecan 150-180 mg/m2 IV on Days 1 and 15, Q4W	Drug	Investigator's choice arm
TAS-102TAS-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	Investigator's choice arm
ApatinibApatinib 500-850 mg at Investigator's discretion based on participant's condition and tolerability, orally once daily, Q4W (China only)	Drug	Investigator's choice arm

Primary outcome

Progression Free Survival (PFS) in all randomized participants
Time frame: From date of first dose/randomisation until disease progression or death in the absence of progression (approximately 3 years).
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.
Overall Survival (OS) for 3L+ participants
Time frame: From date of first dose/randomisation until the date of death due to any cause (approximately 3 years).
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.

12 secondary outcomes

OS in all randomized participants
Time frame: From date of first dose/randomisation until the date of death due to any cause (approximately 3 years).
PFS for 3L+ participants
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From the date of first documented confirmed response until date of documented progression (approximately 3 years).
Serum concentrations of AZD0901, total antibody and MMAE
Time frame: From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation.
Status of ADA to AZD0901
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation.
Prevalence and incidence of ADA to AZD0901
Time frame: From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation.
Titer of ADA to AZD0901
Time frame: From date of first dose of AZD0901 up until 30 days post AZD0901 discontinuation.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
Derived from this study: PubMed 40341124Yu J, Mehta R. Biomarker-Driven Approach to the Treatment of Metastatic Gastric or Gastroesophageal Adenocarcinoma. J Natl Compr Canc Netw. 2025 May;23(5):e257036. doi: 10.6004/jnccn.2025.7036.
Derived from this study: PubMed 39232496Xu 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.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

158 sites in 19 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AZD0901, Ramucirumab+ paclitaxel and Paclitaxel in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by AstraZeneca at 158 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 158 sites in China, United States, Germany, Japan, Poland and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) in all randomized participants (time frame: From date of first dose/randomisation until disease progression or death in the absence of progression (approximately 3 years).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06346392, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.