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TERMINATEDPhase 1NCT04986865

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

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.

Lead sponsor: Antengene Biologics Limited•3 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Antengene Biologics Limited

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 9, 2025Terms

Trial snapshot

StatusTERMINATED

PhasePHASE1

Enrollment31

Start dateDec 2021

Last updatedJun 9, 2025

Condition

Advanced Solid Tumor Metastatic Solid Tumor Mature B-cell Non-Hodgkin Lymphoma

Locations shown

University of California San Francisco

San Francisco, California

Washington University School of Medicine in St. Louis

St Louis, Missouri

Fox Chase Cancer Center

Philadelphia, Pennsylvania

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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: May 10, 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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