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

NCT ID: NCT05490043

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-30
• Study Completion Date: 2025-03-17

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; 1-20 subjects for enhanced PDx cohort. Dose Expansion Phase: Estimated between 2 and 5 cohorts, each of approximately 40-50 patients to be expanded.

Conditions

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

Study Design

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

Study Groups

ATG-101

Dose Escalation Phase:

Will be conducted with an enhanced PDx cohort.

Dose Expansion Phase:

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 28 days. 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 28 days. 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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Antengene (Hangzhou) Biologics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hao Cui, MD

Role: STUDY_DIRECTOR

Medical Physician

Locations

Shandong Cancer Hospital

Jinan, , China

The First Affiliated Hospital of Nanchang University

Nanchang, , China

Shanghai Dongfang Hospital

Shanghai, , China

Henan Cancer Hospital

Zhengzhou, , China

Countries

China

Other Identifiers

ATG-101-001-CN

Identifier Type: -

Identifier Source: org_study_id