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Trial Title:
A Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
NCT ID:
NCT05490043
Condition:
Advanced Solid Tumor
Metastatic Solid Tumor
Mature B-cell Non-Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Neoplasms
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ATG-101
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.
Arm group label:
ATG-101
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yuping Sun, PhD
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jinhua Wen, PhD
Facility:
Name:
Shanghai Dongfang Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Ye Guo, PhD
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Suxia Luo, PhD
Start date:
January 30, 2022
Completion date:
December 30, 2024
Lead sponsor:
Agency:
Antengene (Hangzhou) Biologics Co., Ltd.
Agency class:
Industry
Source:
Antengene Corporation
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05490043
