New targeted drug shows promise in stomach cancer trial

NCT ID NCT06346392

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 10, 2026 · Updated 3 times

Summary

This Phase 3 trial tests a new drug called AZD0901 against standard chemotherapy in 592 adults with advanced stomach or gastroesophageal junction cancer that has not responded to prior treatments. The drug targets a protein called CLDN18.2 found on some cancer cells. The study measures how long patients live without their cancer worsening and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: AZD0901 (also called Sonesitatug Vedotin)
What this could lead to: If successful, this could provide a new treatment option for people with advanced gastric cancer that has not responded to prior therapies.
What could go wrong: This is a Phase 3 trial, but results are not yet available. The drug may not improve survival or could have side effects. It is only for patients with a specific protein (CLDN18.2) on their tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

594 people

The number who actually took part.

Started

Mar 2024

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastric cancer gastric neoplasm gastroesophageal cancer gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric cancer Gastroesophageal junction cancer

Contacts and locations

Locations

Research Site

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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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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Washington D.C., District of Columbia, 20007, United States
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Hollywood, Florida, 33021, United States
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Orlando, Florida, 32804, United States
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Marietta, Georgia, 30060, United States
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Boise, Idaho, 83712, United States
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Lexington, Kentucky, 40536, 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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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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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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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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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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Beijing, 100210, China
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Changchun, 130021, 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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Nanjing, 210008, China
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Qingdao, 266034, 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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Berlin, 10249, Germany
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Berlin, 13353, 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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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, 999077, Hong Kong
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Ahmedabad, 380015, 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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Naples, 80131, Italy
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Padova, 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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Słupsk, 76-200, 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, 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

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