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

NCT05490043 | Terminated Phase 1

• 1 other identifier: ATG-101-001-CN
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• ORR

  One year after last patient first dose

• DCR

  One year after last patient first dose

• PFS

  One year after last patient first dose

• OS

  One year after last patient first dose

• The incidence of ADA and NAb

  One year after last patient first dose

Study Arms (1)

ATG-101

EXPERIMENTAL

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

Interventions

ATG-101 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.

ATG-101

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
• Aged 18 to 75 years as of the date of consent.
• Histological or cytological confirmation of a solid tumor, and has relapsed or refractory from standard therapies.
• Subjects with solid tumors have at least 1 measurable lesion per RECIST v1.1.
• Estimated life expectancy of a minimum of 12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.

You may not qualify if:

• Subjects with CNS tumors or known CNS metastases will be excluded from the Dose Escalation Phase.
• Prior treatment with a 4-1BB agonist.
• Subjects with primary liver cancer.
• Known history of human immunodeficiency virus infection.
• History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-101.
• Pregnant or nursing females.

Sponsors & Collaborators

• Antengene (Hangzhou) Biologics Co., Ltd.: lead

Study Sites (4)

Shandong Cancer Hospital

Jinan, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, China

Location

Shanghai Dongfang Hospital

Shanghai, China

Location

Henan Cancer Hospital

Zhengzhou, China

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hao Cui, MD

  Medical Physician

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: August 5, 2022
• Study Start: January 30, 2022
• Primary Completion: March 17, 2025
• Study Completion: March 17, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-06

Locations

CN (4)