TERMINATED

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

Conditions

Advanced Solid Tumor Metastatic Solid Tumor Mature B-cell Non-Hodgkin Lymphoma Solid tumor, lymphoma, bispecific, antibody

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-12-15

Study Completion:2025-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT04986865

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Locations (Sites)

University of California San Francisco

San Francisco, California, 94143

United States

Washington University School of Medicine in St. Louis

Saint Louis, Missouri, 63110

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

Collaborators and Investigators

Sponsor: Antengene Biologics Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-15

Study Completion Date2025-01-31

Study Record Updates

Study Start Date2021-12-15

Study Completion Date2025-01-31

Terms related to this study

Keywords Provided by Researchers

Solid tumor, lymphoma, bispecific, antibody

Additional Relevant MeSH Terms

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