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

Advanced Solid Tumor Clinical Trial

Official title:

A 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: NCT05490043
• Other study ID #: ATG-101-001-CN
• Status: Recruiting
• Phase: Phase 1
• Start date: January 30, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: April 2024
• Source: Antengene Corporation
• Contact: Sara Wang
• Phone: 17601350610
• Email: sara.wang[@]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; 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: December 30, 2024
• Est. primary completion date: August 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

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 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.

Locations

Country	Name	City	State
China	Shandong Cancer Hospital	Jinan
China	The First Affiliated Hospital of Nanchang University	Nanchang
China	Shanghai Dongfang Hospital	Shanghai
China	Henan Cancer Hospital	Zhengzhou

Sponsors (1)

Lead Sponsor	Collaborator
Antengene (Hangzhou) Biologics Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AEs/SAEs	Toxicity will be graded according to the NCI CTCAE, Version 5.0.	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	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	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
Secondary	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