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New drug ATG-022 enters human testing for Hard-to-Treat cancers

NCT ID NCT05718895

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing a new drug called ATG-022 in people with advanced or metastatic solid tumors that have not responded to standard treatments. The main goal is to find a safe dose and check for side effects. Up to 156 participants will receive the drug every three weeks, and researchers will also watch for any signs that the tumors shrink or stop growing.

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 (a drug given by IV every 3 weeks)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced solid tumors that have stopped responding to standard therapies.
What could go wrong
This is a very early Phase 1 trial with only 156 participants, focused on finding a safe dose. It is too soon to know if ATG-022 will shrink tumors or improve survival, and there may be side effects.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 156 people

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

Started

Mar 2023

Expected to finish

Dec 2027

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 at least 18 years as of the date of consent. 3. Histological or cytological confirmation of a solid tumor, and have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or not applicable for standard therapy(ies). 1. Dose Escalation Phase: all solid tumors. 2. Dose Expansion Phase: Claudin 18.2 positive solid tumors. 4. Subjects should be willing to receive a biopsy at screening, if no former available tumor tissue samples within 36 months prior to participating in the study are provided. 5. At least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. 6. Estimated life expectancy of a minimum of 12 weeks. 7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 . 8. Females should be using adequate contraceptive measures until 180 days after the end of treatment, should not be breastfeeding, and must have a negative pregnancy test prior to the start of dosing if of child-bearing potential or must have evidence of nonchild-bearing potential by fulfilling one of the following criteria at screening 9. Male subjects should be willing to use effective contraception, ie condoms, for the duration of the study and 180 days after the final dose of study treatment. Exclusion Criteria: 1. Primary central nervous system disease or central nervous system metastatic disease. 2. Prior exposure to a Claudin 18.2 targeting agent. 3. Prior therapy with any chemotherapy, immunotherapy, anticancer agents, or investigational products from a previous clinical study within 28 days of 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 (eg, a period of 5 'half-lives'. 4. Prior vaccination within 28 days of the first dose of study therapy. 5. Prior any solid organ transplant. Autologous stem cell transplant or CAR-T cell infusion \< 6 months prior to the first dose of study treatment. 6. Active infection including hepatitis B, and/or hepatitis C. 7. Known history of human immunodeficiency virus (HIV) infection. 8. Any unresolved toxicities from prior therapy greater than Grade 1 at the time of ICF signature, with the exception of alopecia. 9. Pregnant or nursing females. 10. History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-022. 11. Other primary malignancies developed within 5 years prior to the first dose of the study drug, except locally curable malignancies after radical treatment . 12. In the opinion of the investigator, subject's complications, or other conditions (psychological, familial, sociological, or geographical etc.) may affect protocol compliance or may be unsuitable for participation in the study.

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Conditions

The condition(s) this trial relates to.

metastatic malignant neoplasm neoplasm

As listed by the trial registrant

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

Advanced/metastatic solid tumors

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    21 sites in 2 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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, China

  • Beijing GoBroad Hospital

    RECRUITING

    Beijing, China

  • Cabrini Health Limited

    RECRUITING

    Malvern, Australia

    Contact Email: •••••@•••••

  • Cancer Research SA Pty Ltd

    COMPLETED

    Adelaide, Australia

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, China

  • Gansu provincial cancer hospital [recruiting]

    RECRUITING

    Lanzhou, China

  • General Hospital of Ningxia Medical University

    RECRUITING

    Yinchuan, China

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, China

  • Integrated Clinical Oncology Network Pty Ltd (Icon)

    RECRUITING

    South Brisbane, Australia

  • Jinan Central Hospital

    RECRUITING

    Jinan, China

  • Liaoning Cancer Hospital

    RECRUITING

    Shenyang, China

  • Shanxi provincial cancer hospital

    RECRUITING

    Taiyuan, China

  • The Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, China

  • The First Affiliated Hospital of Zhenghzou University

    RECRUITING

    Zhengzhou, China

  • The First affiliated hospital of Xi'An Jiao Tong Ubiversity

    RECRUITING

    Xi'an, China

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiangzhuang, China

  • Tianjin Medical Universuty Cancer Institute & Hospital

    RECRUITING

    Tianjin, China

  • Tongren Hospital Shanghai

    RECRUITING

    Shanghai, China

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, China

  • Xuzhou Central Hospital

    RECRUITING

    Xuzhou, China

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