Testing ATG-101 for advanced solid tumors and B-cell lymphomas

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

This study is testing a new treatment called ATG-101 to see if it can help people with advanced solid tumors and certain types of blood cancers feel better.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Antengene Corporation (Industry-sponsored)
• Locations: 4 sites (Jinan and 3 other locations)
• Trial ID: NCT05490043 on ClinicalTrials.gov

What this trial studies

This Phase I trial evaluates the safety and efficacy of ATG-101 in patients with metastatic or advanced solid tumors and mature B-cell non-Hodgkin lymphomas. The study includes a dose escalation phase with approximately 40-50 subjects, and a dose expansion phase that may involve 2 to 5 cohorts of 40-50 patients each. Participants must have measurable lesions and a life expectancy of at least 12 weeks. The trial aims to assess how well ATG-101 works in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with relapsed or refractory solid tumors or mature B-cell non-Hodgkin lymphomas.

Not a fit: Patients with CNS tumors, primary liver cancer, or those who have previously received a 4-1BB agonist will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat advanced cancers.

How similar studies have performed: While this is a first-in-human trial, similar approaches targeting advanced solid tumors have shown promise in other studies.

Eligibility 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.

Where this trial is running

Jinan and 3 other locations

• Shandong Cancer Hospital — Jinan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, China (Not_yet_recruiting)
• Shanghai Dongfang Hospital — Shanghai, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Sara Wang

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