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

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

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.

Study Overview

• Status: Terminated
• Conditions: Advanced Solid Tumor; Metastatic Solid Tumor; Mature B-cell Non-Hodgkin Lymphoma
• Intervention / Treatment: Drug: ATG-101

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jinan, China
    • Shandong Cancer Hospital
  • Nanchang, China
    • The First Affiliated Hospital of Nanchang University
  • Shanghai, China
    • Shanghai Dongfang Hospital
  • Zhengzhou, China
    • Henan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AEs/SAEs	Toxicity will be graded according to the NCI CTCAE, Version 5.0.	One year after last patient first dose
DLT (for Dose Escalation Phase only)	The DLTs will be evaluated during Cycle 1 of treatment. Toxicity will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events. The DLTs for this study may include the following: Cytokine release syndrome, Hematologic toxicity, Non-hematologic toxicity.	One year after last patient first dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	To evaluate preliminary anti tumor activity of ATG-101	One year after last patient first dose
DCR	To evaluate preliminary anti tumor activity of ATG-101	One year after last patient first dose
PFS	To evaluate preliminary anti tumor activity of ATG-101	One year after last patient first dose
OS	To evaluate preliminary anti tumor activity of ATG-101	One year after last patient first dose
The incidence of ADA and NAb	To evaluate the immunogenicity of ATG-101	One year after last patient first dose
Peak Plasma Concentration (Cmax)	To evaluate the maximum plasma concentration (Cmax) of ATG-101 in Chinese patient population	One year after last patient first dose
Peak Plasma Concentration（Tmax）	To evaluate the time to reach Tmax of ATG-101 in Chinese patient population	One year after last patient first dose

Collaborators and Investigators

• Sponsor: Antengene (Hangzhou) Biologics Co., Ltd.
• Investigators: Study Director: Hao Cui, MD, Medical Physician

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2022
• Primary Completion (Actual): March 17, 2025
• Study Completion (Actual): March 17, 2025

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis
• Other Study ID Numbers: ATG-101-001-CN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No