Clinical trial NCT05490043: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Metastatic Solid Tumor
Mature B-cell Non-Hodgkin Lymphoma
Lead sponsor: Antengene Corporation
Sponsor class: INDUSTRY
First posted: 2022-08-05
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: AEs/SAEs
timeFrame: One year after last patient first dose
measure: DLT (for Dose Escalation Phase only)
timeFrame: One year after last patient first dose
Secondary outcomes:
measure: ORR
timeFrame: One year after last patient first dose
measure: DCR
timeFrame: One year after last patient first dose
measure: PFS
timeFrame: One year after last patient first dose
measure: OS
timeFrame: One year after last patient first dose
measure: The incidence of ADA and NAb
timeFrame: One year after last patient first dose
measure: Peak Plasma Concentration (Cmax)
timeFrame: One year after last patient first dose
measure: Peak Plasma Concentration（Tmax）
timeFrame: One year after last patient first dose
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Cancer Hospital
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
city: Shanghai
country: China
facility: Shanghai Dongfang Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
Study officials:
affiliation: Medical Physician
name: Hao Cui, MD
role: STUDY_DIRECTOR
References: