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TERMINATEDPHASE1

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

A First-in-Human Phase I Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas

NCT04986865•Antengene Biologics Limited

View on ClinicalTrials.gov

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.

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; Dose Expansion Phase: Estimated 100-400 subjects depending on the number of cohorts to be expanded.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

Locations (8)

University of California San Francisco

San Francisco, California, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Scientia Clinical Research Ltd

Randwick, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

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

East Melbourne, Victoria, Australia

Austin Health - Olivia Newton-John Cancer Centre

Heidelberg, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Key Dates

Start Date

December 15, 2021

Primary Completion Date

January 31, 2025

Completion Date

January 31, 2025

Last Updated

June 9, 2025

Enrollment

ACTUAL participants

Conditions

Advanced Solid TumorMetastatic Solid TumorMature B-cell Non-Hodgkin Lymphoma

Interventions

ATG-101

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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