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

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ClinicalTrials.gov Identifier: NCT04986865
Recruitment Status : Recruiting
First Posted : August 3, 2021
Last Update Posted : November 16, 2022
Sponsor:
Information provided by (Responsible Party):
Antengene Corporation ( Antengene Biologics Limited )

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Metastatic Solid Tumor Mature B-cell Non-Hodgkin Lymphoma Drug: ATG-101 Phase 1

Detailed 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; 1-20 subjects for enhanced PDx cohort. Dose Expansion Phase: Estimated 100-400 subjects depending on the number of cohorts to be expanded.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 482 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A First-in-Human Phase I Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
Actual Study Start Date : December 15, 2021
Estimated Primary Completion Date : October 1, 2025
Estimated Study Completion Date : January 1, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: ATG-101

Dose Escalation Phase:

Will be conducted with an enhanced PDx cohort.

Dose Expansion Phase:

Subjects with advanced or metastatic solid tumors and mature B-NHLs will be enrolled.

 Drug: ATG-101
ATG-101 will be administered intravenously once every 21 days. The dose levels will be determined by the starting dose and the escalation steps taken in the trial. The Dose Expansion Phase will begin at the defined MTD, RP2D, or biologically optimal dose.


Outcome Measures
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Primary Outcome Measures :
  1. AEs [ Time Frame: One year after last patient first dose ]

    To evaluate the safety of ATG-101. It is the responsibility of the investigator to record and document all AEs (occurring from the first dose of study treatment on C1D1) throughout the study. Clinically significant symptoms and signs related to disease progression will be reported as AEs and meet one or more of the following criteria:

    1. With clinical symptoms.
    2. Leading to the change of study treatment (eg, dose adjustment, dose interruption, or study drug withdraw).
    3. Leading to the change of concomitant treatment (eg, adding, interrupting, or terminating concomitant medications, therapies, or treatments, or any other changes).

  2. SAEs [ Time Frame: One year after last patient first dose ]

    To evaluate the safety of ATG-101. It is the responsibility of the investigator to record and document all SAEs (occurring from the signing of the informed consent form) throughout the study. A SAE is any untoward medical occurrence that occurs at any dose (including SAEs occurred after the ICF is signed and prior to dosing):

    1. Results in death.
    2. Is life-threatening (immediate risk of death).
    3. Requires inpatient hospitalization or prolongation of existing hospitalization.
    4. Results in persistent or significant disability/incapacity.
    5. Is a congenital anomaly/birth defect. These should also usually be considered serious. Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsive that do not result in hospitalization; or development of drug dependency or drug abuse.

  3. DLT (for Dose Escalation Phase only) [ Time Frame: One year after last patient first dose ]
    The DLTs will be evaluated during Cycle 1 of treatment. Toxicity will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events. The DLTs for this study may include the following: Cytokine release syndrome, Hematologic toxicity, Non-hematologic toxicity.


Secondary Outcome Measures :
  1. ORR [ Time Frame: One year after last patient first dose ]
    To evaluate preliminary anti tumor activity of ATG-101

  2. DOR [ Time Frame: One year after last patient first dose ]
    To evaluate preliminary anti tumor activity of ATG-101

  3. DCR [ Time Frame: One year after last patient first dose ]
    To evaluate preliminary anti tumor activity of ATG-101

  4. PFS [ Time Frame: One year after last patient first dose ]
    To evaluate preliminary anti tumor activity of ATG-101

  5. OS [ Time Frame: One year after last patient first dose ]
    To evaluate preliminary anti tumor activity of ATG-101

  6. The incidence of ADA and NAb [ Time Frame: One year after last patient first dose ]
    To evaluate the immunogenicity of ATG-101

  7. Serum concentrations of ATG-101 and derived PK parameters (for Dose Escalation Phase only) [ Time Frame: One year after last patient first dose ]
    To characterize the PK of ATG 101 (for Dose Escalation Phase only)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 has progressed despite standard therapy, or is intolerant to standard therapy, or has a tumor for which no standard therapy exists or for which standard therapy is not considered adequate. 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 as requested.

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 the first 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 greater than 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 drugs with 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 study treatment. Exceptions are as follows: the disease under study; adequately treated basal 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 may affect protocol compliance or may be unsuitable for participation in the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04986865


Contacts
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Contact: Sunny He 15000411862 sunny.he@antengene.com
Contact: Stephanie Zou stephanie.zou@antengene.com

Locations
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United States, California
University of California San Francisco Not yet recruiting
San Francisco, California, United States, 94143
Contact: Michelle Melisko, PhD         
United States, Colorado
University of Colorado Hospital Not yet recruiting
Boulder, Colorado, United States, 80309
Contact: Thomas Flaig, PhD         
United States, Illinois
Northwestern University Not yet recruiting
Chicago, Illinois, United States, 60208
Contact: Devalingam Mahalingam, PhD         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Anthony Olszanski, PhD         
Australia, New South Wales
Scientia Clinical Research Ltd Recruiting
Randwick, New South Wales, Australia, 2031
Contact: Charlotte Lemech         
Principal Investigator: Charlotte Lemech         
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Michae Brown, PhD         
Australia, Victoria
Peter MacCallum Cancer Centre (PMCC) - Victorian Comprehensive Cancer Centre Location (Peter MacCallum Cancer Centre - East Melbourne) Recruiting
East Melbourne, Victoria, Australia, 8006
Contact: Jayesh Desai         
Principal Investigator: Jayesh Desai         
Austin Health - Olivia Newton-John Cancer Centre Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Hui Gan         
Principal Investigator: Hui Gan         
The Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Mark Voskoboynik         
Principal Investigator: Mark Voskoboynik         
Sponsors and Collaborators
Antengene Biologics Limited
More Information
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Responsible Party: Antengene Biologics Limited
ClinicalTrials.gov Identifier: NCT04986865    
Other Study ID Numbers: ATG-101-001
First Posted: August 3, 2021    Key Record Dates
Last Update Posted: November 16, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Neoplasms
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases