Back to resultsA Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
Primary Purpose
Advanced Solid Tumor, Metastatic Solid Tumor, Mature B-cell Non-Hodgkin Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
ATG-101
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Solid Tumor
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Shandong Cancer Hospital
- The First Affiliated Hospital of Nanchang University
- Shanghai Dongfang HospitalRecruiting
- Henan Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ATG-101
Arm Description
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.
Outcomes
Primary Outcome Measures
AEs/SAEs
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
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.
Secondary Outcome Measures
ORR
To evaluate preliminary anti tumor activity of ATG-101
DCR
To evaluate preliminary anti tumor activity of ATG-101
PFS
To evaluate preliminary anti tumor activity of ATG-101
OS
To evaluate preliminary anti tumor activity of ATG-101
The incidence of ADA and NAb
To evaluate the immunogenicity of ATG-101
Peak Plasma Concentration (Cmax)
To evaluate the maximum plasma concentration (Cmax) of ATG-101 in Chinese patient population
Peak Plasma Concentration（Tmax）
To evaluate the time to reach Tmax of ATG-101 in Chinese patient population
Full Information
NCT ID
NCT05490043
First Posted
July 26, 2022
Last Updated
September 13, 2023
Sponsor
Antengene (Hangzhou) Biologics Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05490043
Brief Title
A Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
Official Title
A Phase I Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2022 (Actual)
Primary Completion Date
August 15, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antengene (Hangzhou) Biologics Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor, Metastatic Solid Tumor, Mature B-cell Non-Hodgkin Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ATG-101
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ATG-101
Intervention Description
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.
Primary Outcome Measure Information:
Title
AEs/SAEs
Description
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
Time Frame
One year after last patient first dose
Title
DLT (for Dose Escalation Phase only)
Description
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.
Time Frame
One year after last patient first dose
Secondary Outcome Measure Information:
Title
ORR
Description
To evaluate preliminary anti tumor activity of ATG-101
Time Frame
One year after last patient first dose
Title
DCR
Description
To evaluate preliminary anti tumor activity of ATG-101
Time Frame
One year after last patient first dose
Title
PFS
Description
To evaluate preliminary anti tumor activity of ATG-101
Time Frame
One year after last patient first dose
Title
OS
Description
To evaluate preliminary anti tumor activity of ATG-101
Time Frame
One year after last patient first dose
Title
The incidence of ADA and NAb
Description
To evaluate the immunogenicity of ATG-101
Time Frame
One year after last patient first dose
Title
Peak Plasma Concentration (Cmax)
Description
To evaluate the maximum plasma concentration (Cmax) of ATG-101 in Chinese patient population
Time Frame
One year after last patient first dose
Title
Peak Plasma Concentration（Tmax）
Description
To evaluate the time to reach Tmax of ATG-101 in Chinese patient population
Time Frame
One year after last patient first dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Wang
Phone
17601350610
Email
sara.wang@antengene.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sunny He
Phone
18721521865
Email
sunny.he@antengene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Jiang, MD
Organizational Affiliation
Medical Physician
Official's Role
Study Director
Facility Information:
Facility Name
Shandong Cancer Hospital
City
Jinan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuping Sun, PhD
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinhua Wen, PhD
Facility Name
Shanghai Dongfang Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ye Guo, PhD
Facility Name
Henan Cancer Hospital
City
Zhengzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suxia Luo, PhD
12. IPD Sharing Statement
Learn more about this trial
A Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
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