Advanced Solid TumorPhase 1NCT05490043
A Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
A Phase 1 study testing ATG-101 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Antengene (Hangzhou) Biologics Co., Ltd. at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor, Metastatic Solid Tumor, Mature B-cell Non-Hodgkin Lymphoma
- What is being tested?
- ATG-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 4 sitesChina
- Study dates
- 30 Jan 2022to 17 Mar 2025
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
Shandong Cancer Hospital
Jinan
The First Affiliated Hospital of Nanchang University
Nanchang
Shanghai Dongfang Hospital
Shanghai
Henan Cancer Hospital
Zhengzhou
About this study
Official title: A 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.
Read the 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.
- Being tested
- ATG-101
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG-101Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| ATG-101 | Experimental | 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. Receives: Drug: ATG-101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs/SAEs
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
Measured: 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.
Measured: One year after last patient first dose
Secondary outcomes (7)
ORR
To evaluate preliminary anti tumor activity of ATG-101
Measured: One year after last patient first dose
DCR
To evaluate preliminary anti tumor activity of ATG-101
Measured: One year after last patient first dose
PFS
To evaluate preliminary anti tumor activity of ATG-101
Measured: One year after last patient first dose
OS
To evaluate preliminary anti tumor activity of ATG-101
Measured: One year after last patient first dose
The incidence of ADA and NAb
To evaluate the immunogenicity of ATG-101
Measured: 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
Measured: 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
Measured: One year after last patient first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start30 Jan 2022
- Primary completion17 Mar 2025
- Study completion17 Mar 2025
Why it stopped: The sponsor has decided to adjust the development strategy of the investigational drug in this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antengene (Hangzhou) Biologics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hao Cui, MD, Study director, Medical Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05490043
- Sponsor's protocol ID
- ATG-101-001-CN
- Status last verified
- Jun 2025
- First submitted
- 26 Jul 2022
- Last updated
- 29 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No