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

• Status: Recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Antengene (Hangzhou) Biologics Co., Ltd.

Criteria

Inclusion Criteria:

1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.

2. Aged 18 to 75 years as of the date of consent.

3. Histological or cytological confirmation of a solid tumor, and has relapsed or refractory from standard therapies.

4. Subjects with solid tumors have at least 1 measurable lesion per RECIST v1.1.

5. Estimated life expectancy of a minimum of 12 weeks.

6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.

Exclusion Criteria:

1. Subjects with CNS tumors or known CNS metastases will be excluded from the Dose Escalation Phase.

2. Prior treatment with a 4-1BB agonist.

3. Subjects with primary liver cancer.

4. Known history of human immunodeficiency virus infection.

5. History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-101.

6. Pregnant or nursing females.