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New hope for stomach cancer: experimental drug combo targets tough tumors

NCT ID NCT07327229

Disease control Sponsor: Antengene Biologics Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 30, 2026 · Updated 6 times

Summary

This study tests a new drug called ATG-022 combined with the immunotherapy pembrolizumab (Keytruda), with or without chemotherapy, in people with advanced stomach or gastroesophageal junction cancer that has a specific marker (CLDN18.2) and is HER2-negative. The trial aims to find the best dose and see if the combination shrinks tumors or slows cancer growth. About 132 participants will be enrolled.

What this could mean

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

Active substance
ATG-022 (an experimental antibody) plus pembrolizumab (Keytruda) with or without chemotherapy (capecitabine and oxaliplatin)
What this could lead to
If successful, this could provide a new treatment option for people with a specific type of advanced stomach cancer that has limited current therapies.
What could go wrong
This is an early-phase trial (phase 1/2) with a small number of participants, so the combination may not prove effective or safe enough for wider use. Side effects from the drugs and chemotherapy are possible.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 132 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Apr 2029

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 years and older

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. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses. 2. Aged ≥18 years as of the date of consent. 3. Histological or cytological confirmation of gastric cancer or gastroesophageal junction adenocarcinoma with CLDN 18.2 positive, HER2-negative and PD-L1 positive expression. 4. Archival tumor tissue sample within 36 months prior to participating in the study or newly obtained biopsy of a tumor lesion not previously irradiated should be provided for testing of CLDN 18.2 and PD-L1 expression for determining the criteria. 5. At least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 by investigators. 6. Estimated life expectancy of a minimum of 12 weeks. Exclusion Criteria: 1. Known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention. 2. Prior exposure to CLDN 18.2 ADC, CLDN 18.2 chimeric antigen receptor T-cell immunotherapy or agents containing MMAE. 3. Prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study treatment or within a period during which the investigational product or systemic anticancer treatment has not been cleared from the body (e.g., a period of 5 'halflives'), whichever is the most appropriate as judged by the investigator. 4. Received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis. 5. Prior radiotherapy within 4 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids. Two weeks or fewer of palliative radiotherapy for non- central nervous system disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention 6. Prior a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed. 7. Prior major surgery (excluding placement of vascular access) within 28 days of the first dose of study treatment or minor surgical procedures≤7 days. No waiting is required following implantable port and catheter placement.

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastroesophageal junction adenocarcinoma

As listed by the trial registrant

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

Unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Anhui Provincial Hospital

    RECRUITING

    Hefei, Anhui, China

  • Anyang Tumor Hospital

    RECRUITING

    Anyang, Henan, China

  • Beijing Cancer hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Cancer Institute&Hospital Chinese Academy of Medical Sciences

    NOT_YET_RECRUITING

    Langfang, Hebei, China

  • Fujian Provincial Cnacer Hospital

    RECRUITING

    Fuzhou, Fujian, China

  • Gansu Provincial Cnacer Hospital

    NOT_YET_RECRUITING

    Lanzhou, Gansu, China

  • General Hospital of Ningxia Medical University

    RECRUITING

    Yinchuan, Ningxia, China

  • Henan Cnacer Hospital

    NOT_YET_RECRUITING

    Zhengzhou, Henan, China

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, Hubei, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, China

  • Jinan Central Hospital

    RECRUITING

    Jinan, Shandong, China

  • Shandong Cancer Hospital &Institue

    RECRUITING

    Jinan, Shandong, China

  • Shanxi provincial cancer hospital

    RECRUITING

    Taiyuan, Shanxi, China

  • The Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, Shandong, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, China

  • The First Affiliated Hospital of Henan Medical Hospital

    RECRUITING

    Xinxiang, Henan, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, China

  • The First Affiliated Hospital of XI'AN Jiaotong University

    RECRUITING

    Xi’an, Shanxi, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Wenzhou, Zhejiang, China

  • The First Affiliated Hospital of Zhenghzou University

    RECRUITING

    Zhengzhou, Henan, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, China

  • The First Hospital of Shanxi Medical University

    RECRUITING

    Taiyuan, Shanxi, China

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, China

  • The Second Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, China

  • Tianjin Medical Universuty Cancer Institute & Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

  • Tongji Medical College of HUST

    RECRUITING

    Wuhan, Hubei, China

  • Tongren Hospital Shanghai Jiaotong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, Sichuan, China

  • Xuzhou Central Hospital

    NOT_YET_RECRUITING

    Xuzhou, Jiangsu, China

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