TerminatedPhase 1

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

Stopped: It is due to the recent changes in the competitor landscape and strategic consideration

United States, Australia31 participantsStarted 2021-12-15

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

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 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.

✕. 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.
✕

AEs

Timeframe: One year after last patient first dose

SAEs

Timeframe: One year after last patient first dose

DLT (for Dose Escalation Phase only)

Timeframe: One year after last patient first dose

NCT IDNCT04986865

SponsorAntengene Biologics Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-31

Who can participate

Age range18 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 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.

✕. 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.
✕