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

NCT04986865 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: ATG-101-001
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 8

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

Keywords

Solid tumor, lymphoma, bispecific, antibody

Outcome Measures

Primary Outcomes (3)

• AEs

  To evaluate the safety of ATG-101. It is the responsibility of the investigator to record and document all AEs (occurring from the first dose of study treatment on C1D1) throughout the study. Clinically significant symptoms and signs related to disease progression will be reported as AEs and meet one or more of the following criteria: 1. With clinical symptoms. 2. Leading to the change of study treatment (eg, dose adjustment, dose interruption, or study drug withdraw). 3. Leading to the change of concomitant treatment (eg, adding, interrupting, or terminating concomitant medications, therapies, or treatments, or any other changes).

  One year after last patient first dose

• SAEs

  To evaluate the safety of ATG-101. It is the responsibility of the investigator to record and document all SAEs (occurring from the signing of the informed consent form) throughout the study. A SAE is any untoward medical occurrence that occurs at any dose (including SAEs occurred after the ICF is signed and prior to dosing): 1. Results in death. 2. Is life-threatening (immediate risk of death). 3. Requires inpatient hospitalization or prolongation of existing hospitalization. 4. Results in persistent or significant disability/incapacity. 5. Is a congenital anomaly/birth defect. These should also usually be considered serious. Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsive that do not result in hospitalization; or development of drug dependency or drug abuse.

  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

• DOR

  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

Study Arms (1)

Single experimental arm for ATG-101

EXPERIMENTAL

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 21 days. During the Escalation Phase, 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.

Single experimental arm for ATG-101

Eligibility Criteria

• Age: 18 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 at least 18 years as of the date of consent.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Female and male subjects should be using adequate contraceptive measures as requested.

You may not qualify if:

• Subjects with CNS tumors or known CNS metastases will be excluded.
• Prior ATG-101 administration or a 4-1BB agonist.
• Prior anti-tumor systemic therapy within 21 days(a period of 5 'half- lives') of the first dose of study treatment.
• Radiotherapy with a wide field of radiation within 28 days.
• With the exception of alopecia, any unresolved toxicities from prior therapy greater than Grade 1 (CTCAE v5.0) at the time of ICF signature.
• Active infection, including hepatitis B and/or hepatitis C.
• Have uncontrolled intercurrent illness, including but not limited to:
• Inadequate bone marrow reserve or organ function.
• History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-101.
• Prior organ allograft transplantations.
• Pregnant or nursing females.
• 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.
• 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.

Sponsors & Collaborators

• Antengene Biologics Limited: lead

Study Sites (8)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Scientia Clinical Research Ltd

Randwick, New South Wales, 2031, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Peter MacCallum Cancer Centre (PMCC) - Victorian Comprehensive Cancer Centre Location (Peter MacCallum Cancer Centre - East Melbourne)

East Melbourne, Victoria, 8006, Australia

Location

Austin Health - Olivia Newton-John Cancer Centre

Heidelberg, Victoria, 3084, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Lymphoma

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

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

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 3, 2021
• Study Start: December 15, 2021
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: June 9, 2025

Record last verified: 2025-05

Locations

AU (5); US (3)