Testing ATG-101 in patients with advanced solid tumors and lymphomas

A First-in-Human 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 drug called ATG-101 to see if it can help people with advanced solid tumors and certain types of lymphomas.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Antengene Corporation (industry)
• Drugs / interventions: radiation
• Locations: 8 sites (San Francisco, California and 7 other locations)
• Trial ID: NCT04986865 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 consists of a dose escalation phase involving approximately 40-50 subjects, with a potential expansion phase that could include 100-400 additional participants based on cohort responses. Participants will receive ATG-101, and the study aims to determine the optimal dosing and assess the drug's effects on tumor progression.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed advanced solid tumors or mature B-cell non-Hodgkin lymphomas that have progressed despite standard treatments.

Not a fit: Patients with central nervous system tumors or known CNS metastases will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancers that have limited or no effective standard therapies.

How similar studies have performed: Other studies involving bispecific antibodies have shown promise, suggesting potential for success with this novel approach.

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.

Where this trial is running

San Francisco, California and 7 other locations

• University of California San Francisco — San Francisco, California, United States (RECRUITING)
• Washington University School of Medicine in St. Louis — Saint Louis, Missouri, United States (RECRUITING)
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (RECRUITING)
• Scientia Clinical Research Ltd — Randwick, New South Wales, Australia (RECRUITING)
• Royal Adelaide Hospital — Adelaide, South Australia, Australia (RECRUITING)
• Peter MacCallum Cancer Centre (PMCC) - Victorian Comprehensive Cancer Centre Location (Peter MacCallum Cancer Centre - East Melbourne) — East Melbourne, Victoria, Australia (RECRUITING)
• Austin Health - Olivia Newton-John Cancer Centre — Heidelberg, Victoria, Australia (RECRUITING)
• The Alfred Hospital — Melbourne, Victoria, Australia (RECRUITING)

Study contacts

• Study coordinator: Sunny He

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