TerminatedPhase 1

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

Stopped: The sponsor has decided to adjust the development strategy of the investigational drug in this study.

China33 participantsStarted 2022-01-30

Plain-language 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.

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
✓. Aged 18 to 75 years as of the date of consent.
✓. Histological or cytological confirmation of a solid tumor, and has relapsed or refractory from standard therapies.
✓. Subjects with solid tumors have at least 1 measurable lesion per RECIST v1.1.
✓. Estimated life expectancy of a minimum of 12 weeks.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.

✕. Subjects with CNS tumors or known CNS metastases will be excluded from the Dose Escalation Phase.
✕. Prior treatment with a 4-1BB agonist.
✕. Subjects with primary liver cancer.
✕. Known history of human immunodeficiency virus infection.
✕. History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-101.
✕. Pregnant or nursing females.

AEs/SAEs

Timeframe: One year after last patient first dose

DLT (for Dose Escalation Phase only)

Timeframe: One year after last patient first dose

NCT IDNCT05490043

SponsorAntengene (Hangzhou) Biologics Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-17

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
✓. Aged 18 to 75 years as of the date of consent.
✓. Histological or cytological confirmation of a solid tumor, and has relapsed or refractory from standard therapies.
✓. Subjects with solid tumors have at least 1 measurable lesion per RECIST v1.1.
✓. Estimated life expectancy of a minimum of 12 weeks.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.

✕. Subjects with CNS tumors or known CNS metastases will be excluded from the Dose Escalation Phase.
✕. Prior treatment with a 4-1BB agonist.
✕. Subjects with primary liver cancer.
✕. Known history of human immunodeficiency virus infection.
✕. History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-101.
✕. Pregnant or nursing females.