A Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
- Conditions
- Mature B-cell Non-Hodgkin LymphomaAdvanced Solid TumorMetastatic Solid Tumor
- Interventions
- Registration Number
- NCT05490043
- Lead Sponsor
- Antengene (Hangzhou) Biologics Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 62
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ATG-101 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.
- Primary Outcome Measures
Name Time Method 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.
AEs/SAEs One year after last patient first dose Toxicity will be graded according to the NCI CTCAE, Version 5.0.
- Secondary Outcome Measures
Name Time Method DCR One year after last patient first dose To evaluate preliminary anti tumor activity of ATG-101
ORR One year after last patient first dose To evaluate preliminary anti tumor activity of ATG-101
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
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
The incidence of ADA and NAb One year after last patient first dose To evaluate the immunogenicity of ATG-101
PFS One year after last patient first dose To evaluate preliminary anti tumor activity of ATG-101
OS One year after last patient first dose To evaluate preliminary anti tumor activity of ATG-101
Trial Locations
- Locations (4)
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
Shandong Cancer Hospital
🇨🇳Jinan, China
Shanghai Dongfang Hospital
🇨🇳Shanghai, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China