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Advanced/Metastatic Solid TumorsPhase 1CLINCHNCT05718895

A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors

A Phase 1 study testing ATG-022 in people with Advanced/Metastatic Solid Tumors, run by Antengene Biologics Limited at 22 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is an Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients with Advanced/metastatic Solid Tumors Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced/Metastatic Solid Tumors
What is being tested?
ATG-022
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
22 sitesin 2 countries
Study dates
27 Mar 2023to 30 Dec 2027
Phase
Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
  • Aged at least 18 years as of the date of consent.
  • 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).
  • Dose Escalation Phase: all solid tumors.
  • Dose Expansion Phase: Claudin 18.2 positive solid tumors.
  • 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.
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  • At least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.
  • Estimated life expectancy of a minimum of 12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 .
  • 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
  • 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.

Who cannot join

  • Primary central nervous system disease or central nervous system metastatic disease.
  • Prior exposure to a Claudin 18.2 targeting agent.
  • 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'.
  • Prior vaccination within 28 days of the first dose of study therapy.
  • Prior any solid organ transplant. Autologous stem cell transplant or CAR-T cell infusion < 6 months prior to the first dose of study treatment.
  • Active infection including hepatitis B, and/or hepatitis C.
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  • Known history of human immunodeficiency virus (HIV) infection.
  • Any unresolved toxicities from prior therapy greater than Grade 1 at the time of ICF signature, with the exception of alopecia.
  • Pregnant or nursing females.
  • History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-022.
  • Other primary malignancies developed within 5 years prior to the first dose of the study drug, except locally curable malignancies after radical treatment .
  • 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.

Trial locations and contacts

22 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Felix Li contact

021-32501095

felix.li@antengene.com

Sunny He contact

sunny.he@antengene.com

22 sites in 2 countries

China19 sites, 19 recruiting

  • Beijing GoBroad Hospital

    Beijing

    Ming Lu, MD, qiminglu_mail@126.com

    Ming Lu, MD

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu

    Li Zheng, MD, 18980601950@163.com

    Li Zheng, MD

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou

    Rongbo Lin, MD, Rongbo_lin@163.com

    Rongbo Lin, MD

    Recruiting

  • Anhui Provincial Hospital

    Hefei

    Gang Wang, MD, wanggang829@126.com

    Gang Wang, MD

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

    Kangsheng Gu, MD, 13805692145@163.com

    Kangsheng Gu, MD

    Recruiting

  • Jinan Central Hospital

    Jinan

    Meili Sun, MD, smli1980@163.com

    Meili Sun, MD

    Recruiting

  • Gansu provincial cancer hospital [recruiting]

    Lanzhou

    Yuhua Liu, MD, tianlujyx@163.com

    Yuhua Liu, MD

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao

    Jing Lv, MD, qdfy82912773@126.com

    Jing Lv, MD

    Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai

    Hongxia Wang, MD, whx365@126.com

    Hongxia Wang, MD

    Recruiting

  • Tongren Hospital Shanghai

    Shanghai

    Jianjun Zhang, MD, robustzhang168@aliyun.com

    Jianjun Zhang, MD

    Recruiting

  • Liaoning Cancer Hospital

    Shenyang

    Jingdong Zhang, MD, jdzhang@cancerhosp-ln-cmu.com

    Jingdong Zhang, MD

    Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiangzhuang

    Qun Zhao, MD, zhaoqun516@126.com

    Qun Zhao, MD

    Recruiting

  • Shanxi provincial cancer hospital

    Taiyuan

    Jinfeng Ma, MD, mjinfeng99@163.com

    Jinfeng Ma, MD

    Recruiting

  • Tianjin Medical Universuty Cancer Institute & Hospital

    Tianjin

    Ting Deng, MD, xymcdengting@126.com

    Ting Deng, MD

    Recruiting

  • Hubei Cancer Hospital

    Wuhan

    Xinjun Liang, MD, 459992533@qq.com

    Xinjun Liang, MD

    Recruiting

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

    Xi'an

    Aili Suo, MD, Ailisuo@mail.xjtu.edu.cn

    Aili Suo, MD

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou

    Yuan Yuan, MD, wwww8866@163.com

    Yuan Yuan, MD

    Recruiting

  • General Hospital of Ningxia Medical University

    Yinchuan

    Ping Chen, MD, Chenping2536@qq.com

    Ping Chen, MD

    Recruiting

  • The First Affiliated Hospital of Zhenghzou University

    Zhengzhou

    Yanru Qin, MD, yanruqin@163.com

    Yanru Qin, MD

    Recruiting

Other trials in China

Australia3 sites, 2 recruiting

  • Cancer Research SA Pty Ltd

    Adelaide

    Completed

  • Cabrini Health Limited

    Malvern

    Deb Macdonald, researchgovernance@cabrini.com.au

    SHEHARA MENDIS, MD

    Recruiting

  • Integrated Clinical Oncology Network Pty Ltd (Icon)

    South Brisbane

    Senior Operations Manager, CFRemittances@Icon.team

    Jermaine COWARD

    Recruiting

Other trials in Australia

About this study

Official title: An Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients With Advanced/Metastatic Solid Tumors

This is an Open, Multi-center, Phase I Clinical Study of ATG 022 in Patients with Advanced/metastatic Solid Tumors

Read the detailed description

This is a Phase I, multi-center, open-label, dose-finding study of ATG-022 in patients with advanced solid tumours. The study design includes a Dose Escalation Phase which will enroll subjects with advanced/metastatic solid tumors, and a Dose Expansion Phase which will enroll select advanced/metastatic solid tumors with Claudin 18.2-positive expression at the defined maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) to further evaluate the safety, tolerability, and efficacy of ATG-022.

Being tested
ATG-022

What participants receive

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

  • ATG-022Drug

    Dose Escalation Phase:

    A treatment cycle of ATG-022 will be defined as 21 days. Dosing will begin at 0.3 mg/kg once every 3 weeks (Q3W) with 1 subject ,the following dose cohorts (0.9, 1.8, 2.4, 3.0, and 3.6 mg/kg Q3W) will require at least 3 and up to 6 evaluable subjects by using dose escalation plan of "3+3" design.

Study groups in NCT05718895
Study groupRoleWhat they receive
ATG-022ExperimentalDose Escalation Phase: for subjects with solid tumors,approximately 16-36 subjects will be enrolled . Dose Expansion Phase: The tumor types in the Dose Expansion Phase may involve other tumor types based on the signals from the Dose Escalation Phase. The total number of patients in dose expansion will be up to approximately 120 patients.
Receives: Drug: ATG-022

What is being measured

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

  1. DLT

    Number of Participants with Dose Limiting Toxicity

    Measured: Up to 21 Days

  2. MTD

    Maximum Tolerated Dose

    Measured: Up to 21 Days

  3. RP2D

    RP2D= Recommended Phase 2 Dose

    Measured: Up to 21 Days

Secondary outcomes (3)

  1. PFS

    Progression Free Survival

    Measured: 12 months after the last subject enrolled

  2. ORR

    Overall Response Rate

    Measured: 12 months after the last subject enrolled

  3. DOR

    Duration of Response

    Measured: 12 months after the last subject enrolled

Timeline

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

  1. First posted8 Feb 2023
  2. Study start27 Mar 2023
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
A treatment cycle of ATG-022 will be defined as 21 days. Dosing will begin at 0.3 mg/kg Q3W with 1 subject
Masking
None (open label)
Enrolment
156 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05718895
Sponsor's protocol ID
ATG-022-ST-001
Acronym
CLINCH
Status last verified
Apr 2026
First submitted
17 Jan 2023
Last updated
15 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ATG-022 in people with Advanced/Metastatic Solid Tumors, run by Antengene Biologics Limited at 22 sites in 2 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 12 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: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in China, Australia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Contact Felix Li (021-32501095, felix.li@antengene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLT (time frame: Up to 21 Days). The study lists 3 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 NCT05718895.

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 Apr 2026.

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