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

• Sponsor: Antengene (Hangzhou) Biologics Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05490043
• Collaborator: (none)
• Enrollment: 62
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 35
• Patients Per Site: 15.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor; Metastatic Solid Tumor; Mature B-cell Non-Hodgkin Lymphoma	Drug: ATG-101	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 62 participants
• Allocation: N/A
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
• Actual Study Start Date: Jan 30, 2022
• Anticipated Primary Completion Date: Aug 15, 2024
• Anticipated Study Completion Date: Dec 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. AEs/SAEs [One year after last patient first dose]

   Toxicity will be graded according to the NCI CTCAE, Version 5.0.

2. DLT (for Dose Escalation Phase only) [One year after last patient first dose]

   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.

Secondary Outcome Measures

1. ORR [One year after last patient first dose]

   To evaluate preliminary anti tumor activity of ATG-101

2. DCR [One year after last patient first dose]

   To evaluate preliminary anti tumor activity of ATG-101

3. PFS [One year after last patient first dose]

   To evaluate preliminary anti tumor activity of ATG-101

4. OS [One year after last patient first dose]

   To evaluate preliminary anti tumor activity of ATG-101

5. The incidence of ADA and NAb [One year after last patient first dose]

   To evaluate the immunogenicity of ATG-101

6. Peak Plasma Concentration (Cmax) [One year after last patient first dose]

   To evaluate the maximum plasma concentration (Cmax) of ATG-101 in Chinese patient population

7. Peak Plasma Concentration（Tmax） [One year after last patient first dose]

   To evaluate the time to reach Tmax of ATG-101 in Chinese patient population

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shandong Cancer Hospital	Jinan		China
2	The First Affiliated Hospital of Nanchang University	Nanchang		China
3	Shanghai Dongfang Hospital	Shanghai		China
4	Henan Cancer Hospital	Zhengzhou		China

Sponsors and Collaborators

• Antengene (Hangzhou) Biologics Co., Ltd.

Investigators

• Study Director: Yiqiang Zhao, MD, Medical Director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Antengene (Hangzhou) Biologics Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05490043
• Other Study ID Numbers: ATG-101-001-CN
• First Posted: Aug 5, 2022
• Last Update Posted: Aug 5, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Neoplasms; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell

Study Results

No Results Posted as of Aug 5, 2022