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

Last updated: June 3, 2025
Sponsor: Antengene Biologics Limited
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

ATG-022

Clinical Study ID

NCT05718895
ATG-022-ST-001
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Provision of signed and dated, written informed consent prior to any study-specificprocedures, 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 progresseddespite standard therapy(ies), or are intolerant to standard therapy(ies), or notapplicable for standard therapy(ies).

  4. Dose Escalation Phase: all solid tumors.

  5. Dose Expansion Phase: Claudin 18.2 positive solid tumors.

  6. Subjects should be willing to receive a biopsy at screening, if no former availabletumor tissue samples within 36 months prior to participating in the study areprovided.

  7. At least 1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1.

  8. Estimated life expectancy of a minimum of 12 weeks.

  9. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 .

  10. Females should be using adequate contraceptive measures until 180 days after the endof treatment, should not be breastfeeding, and must have a negative pregnancy testprior to the start of dosing if of child-bearing potential or must have evidence ofnonchild-bearing potential by fulfilling one of the following criteria at screening

  11. Male subjects should be willing to use effective contraception, ie condoms, for theduration of the study and 180 days after the final dose of study treatment.

Exclusion

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, orinvestigational products from a previous clinical study within 28 days of the firstdose of study treatment or within a period during which the investigational productor 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 cellinfusion < 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 ICFsignature, with the exception of alopecia.

  9. Pregnant or nursing females.

  10. History of hypersensitivity or history of allergic reactions attributed to drugswith 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 thestudy 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 protocolcompliance or may be unsuitable for participation in the study.

Study Design

Total Participants: 156
Treatment Group(s): 1
Primary Treatment: ATG-022
Phase: 1
Study Start date:
March 27, 2023
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Cancer Research SA Pty Ltd

    Adelaide,
    Australia

    Completed

  • Cabrini Health Limited

    Malvern,
    Australia

    Active - Recruiting

  • Integrated Clinical Oncology Network Pty Ltd (Icon)

    South Brisbane,
    Australia

    Active - Recruiting

  • West China Hospital, Sichuan University

    Chengdu,
    China

    Active - Recruiting

  • Fujian Cancer Hospital

    Fuzhou,
    China

    Active - Recruiting

  • Jinan Central Hospital

    Jinan,
    China

    Active - Recruiting

  • Gansu provincial cancer hospital [recruiting]

    Lanzhou,
    China

    Active - Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao,
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai,
    China

    Active - Recruiting

  • Tongren Hospital Shanghai

    Shanghai,
    China

    Active - Recruiting

  • Liaoning Cancer Hospital

    Shenyang,
    China

    Active - Recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiangzhuang,
    China

    Active - Recruiting

  • Shanxi provincial cancer hospital

    Taiyuan,
    China

    Active - Recruiting

  • Hubei Cancer Hospital

    Wuhan,
    China

    Active - Recruiting

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

    Xi'an,
    China

    Active - Recruiting

  • Xuzhou Central Hospital

    Xuzhou,
    China

    Active - Recruiting

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