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

NCT ID: NCT04986865

Last Updated: 2025-06-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-15
• Study Completion Date: 2025-01-31

Brief 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.

Detailed 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. 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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single experimental arm for ATG-101

Subjects with advanced or metastatic solid tumors and mature B-NHLs will be enrolled.

Group Type: EXPERIMENTAL

ATG-101

Intervention Type: DRUG

ATG-101 will be administered intravenously once every 21 days. During the Escalation Phase, the dose levels will be determined by the starting dose and the escalation steps taken in the trial. The Dose Expansion Phase will begin at the defined MTD, RP2D, or biologically optimal dose.

Interventions

ATG-101

ATG-101 will be administered intravenously once every 21 days. During the Escalation Phase, the dose levels will be determined by the starting dose and the escalation steps taken in the trial. The Dose Expansion Phase will begin at the defined MTD, RP2D, or biologically optimal dose.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antengene Biologics Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States; Australia

Other Identifiers

ATG-101-001

Identifier Type: -

Identifier Source: org_study_id