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

Advanced Solid Tumor Clinical Trial

— PROBE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04986865
• Other study ID #: ATG-101-001
• Status: Recruiting
• Phase: Phase 1
• Start date: December 15, 2021
• Est. completion date: January 1, 2026

Study information

• Verified date: February 2024
• Source: Antengene Corporation
• Contact: Sunny He
• Phone: 8618721521865
• Email: sunny.he[@]antengene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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; Dose Expansion Phase: Estimated 100-400 subjects depending on the number of cohorts to be expanded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Mature B-cell Non-Hodgkin Lymphoma
• Metastatic Solid Tumor
• Neoplasms

Intervention

Drug:
• ATG-101
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Antengene Biologics Limited

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: With clinical symptoms.; Leading to the change of study treatment (eg, dose adjustment, dose interruption, or study drug withdraw).; 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
Primary	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): Results in death.; Is life-threatening (immediate risk of death).; Requires inpatient hospitalization or prolongation of existing hospitalization.; Results in persistent or significant disability/incapacity.; 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
Primary	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	ORR	To evaluate preliminary anti tumor activity of ATG-101	One year after last patient first dose
Secondary	DOR	To evaluate preliminary anti tumor activity of ATG-101	One year after last patient first dose
Secondary	DCR	To evaluate preliminary anti tumor activity of ATG-101	One year after last patient first dose
Secondary	PFS	To evaluate preliminary anti tumor activity of ATG-101	One year after last patient first dose
Secondary	OS	To evaluate preliminary anti tumor activity of ATG-101	One year after last patient first dose
Secondary	The incidence of ADA and NAb	To evaluate the immunogenicity of ATG-101	One year after last patient first dose
Secondary	Serum concentrations of ATG-101 and derived PK parameters (for Dose Escalation Phase only)	To characterize the PK of ATG 101 (for Dose Escalation Phase only)	One year after last patient first dose