A Phase 1 interventional study of ATG-101 in Advanced Solid Tumor, Metastatic Solid Tumor and Mature B-cell Non-Hodgkin Lymphoma, sponsored by Antengene (Hangzhou) Biologics Co., Ltd.. Terminated at 4 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-29.
Sponsored by Antengene (Hangzhou) Biologics Co., Ltd. · Phase 1, Interventional, and Treatment
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.
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's enrollment of 33 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →This is the only study on the registry with Antengene (Hangzhou) Biologics Co., Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
AEs/SAEs
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
Time frame: One year after last patient first dose
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.
Time frame: One year after last patient first dose
ORR
To evaluate preliminary anti tumor activity of ATG-101
Time frame: One year after last patient first dose
DCR
To evaluate preliminary anti tumor activity of ATG-101
Time frame: One year after last patient first dose
PFS
To evaluate preliminary anti tumor activity of ATG-101
Time frame: One year after last patient first dose
OS
To evaluate preliminary anti tumor activity of ATG-101
Time frame: One year after last patient first dose
The incidence of ADA and NAb
To evaluate the immunogenicity of ATG-101
Time frame: One year after last patient first dose
Peak Plasma Concentration (Cmax)
To evaluate the maximum plasma concentration (Cmax) of ATG-101 in Chinese patient population
Time frame: One year after last patient first dose
Peak Plasma Concentration（Tmax）
To evaluate the time to reach Tmax of ATG-101 in Chinese patient population
Time frame: One year after last patient first dose
This study is terminated, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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