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

Stopped early · Phase 1

Conditions studied: Advanced Solid Tumor, Metastatic Solid Tumor, Mature B-cell Non-Hodgkin Lymphoma

In brief

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.

Key facts

Study ID

NCT04986865

Run by

Antengene Biologics Limited

People needed

31

Starts

2021-12-15

Expected to finish

2025-01-31

Last updated by the study team

2025-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
• Aged at least 18 years as of the date of consent.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Female and male subjects should be using adequate contraceptive measures as requested.

You may not qualify if…

• Subjects with CNS tumors or known CNS metastases will be excluded.
• Prior ATG-101 administration or a 4-1BB agonist.
• Prior anti-tumor systemic therapy within 21 days(a period of 5 'half- lives') of the first dose of study treatment.
• Radiotherapy with a wide field of radiation within 28 days.
• With the exception of alopecia, any unresolved toxicities from prior therapy greater than Grade 1 (CTCAE v5.0) at the time of ICF signature.
• Active infection, including hepatitis B and/or hepatitis C.
• Have uncontrolled intercurrent illness, including but not limited to:
• Inadequate bone marrow reserve or organ function.
• History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-101.
• Prior organ allograft transplantations.
• Pregnant or nursing females.
• 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.
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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