A Study ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas

Last updated: June 5, 2025
Sponsor: Antengene Biologics Limited
Overall Status: Terminated

Phase

1

Condition

Lymphoma, B-cell

Lymphoma

Neoplasms

Treatment

ATG-101

Clinical Study ID

NCT04986865
ATG-101-001
  • Ages > 18
  • All Genders

Study Summary

This is a First-in-Human Phase I trial of ATG-101 in Patients with Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas.

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 has progresseddespite standard therapy, or is intolerant to standard therapy, or has a tumor forwhich no standard therapy exists or for which standard therapy is not consideredadequate. Estimated life expectancy of a minimum of 12 weeks.

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

  5. Female and male subjects should be using adequate contraceptive measures asrequested.

Exclusion

Exclusion Criteria:

  1. Subjects with CNS tumors or known CNS metastases will be excluded.

  2. Prior ATG-101 administration or a 4-1BB agonist.

  3. Prior anti-tumor systemic therapy within 21 days(a period of 5 'half- lives') of thefirst dose of study treatment.

  4. Radiotherapy with a wide field of radiation within 28 days.

  5. With the exception of alopecia, any unresolved toxicities from prior therapy greaterthan Grade 1 (CTCAE v5.0) at the time of ICF signature.

  6. Active infection, including hepatitis B and/or hepatitis C.

  7. Have uncontrolled intercurrent illness, including but not limited to:

  8. Inadequate bone marrow reserve or organ function.

  9. History of hypersensitivity or history of allergic reactions attributed to drugswith a similar chemical or biologic structure or class to ATG-101.

  10. Prior organ allograft transplantations.

  11. Pregnant or nursing females.

  12. Have a history of another primary malignancy within 3 years prior to starting studytreatment. Exceptions are as follows: the disease under study; adequately treatedbasal or squamous cell carcinoma of the skin; cancer of the cervix in situ, etc.

  13. In the opinion of the investigator, subject's complications or other conditions mayaffect protocol compliance or may be unsuitable for participation in the study.

Study Design

Total Participants: 31
Treatment Group(s): 1
Primary Treatment: ATG-101
Phase: 1
Study Start date:
December 15, 2021
Estimated Completion Date:
January 31, 2025

Study Description

This is a First-in-Human Phase I trial of ATG-101 in Patients with Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas. Dose Escalation Phase: Approximately 40-50 subjects with a maximum number of 62; Dose Expansion Phase: Estimated 100-400 subjects depending on the number of cohorts to be expanded.

Connect with a study center

  • Scientia Clinical Research Ltd

    Randwick, New South Wales 2031
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre (PMCC) - Victorian Comprehensive Cancer Centre Location (Peter MacCallum Cancer Centre - East Melbourne)

    East Melbourne, Victoria 8006
    Australia

    Site Not Available

  • Austin Health - Olivia Newton-John Cancer Centre

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • University of Colorado Hospital

    Boulder, Colorado 80309
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60208
    United States

    Site Not Available

  • Washington University School of Medicine in St. Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

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