Advanced Solid TumorPhase 1PROBENCT04986865
A Study 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 Biologics Limited at 8 sites in 2 countries.
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 years and older
- 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
- 31 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 15 Dec 2021to 31 Jan 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 years and older
- 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 at least 18 years as of the date of consent.
- Histological or cytological confirmation of a solid tumor, and has progressed despite standard therapy, or is intolerant to standard therapy, or has a tumor for which no standard therapy exists or for which standard therapy is not considered adequate. Estimated life expectancy of a minimum of 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Female and male subjects should be using adequate contraceptive measures as requested.
Who cannot join
- Subjects with CNS tumors or known CNS metastases will be excluded.
- Prior ATG-101 administration or a 4-1BB agonist.
- Prior anti-tumor systemic therapy within 21 days(a period of 5 'half- lives') of the first dose of study treatment.
- Radiotherapy with a wide field of radiation within 28 days.
- With the exception of alopecia, any unresolved toxicities from prior therapy greater than Grade 1 (CTCAE v5.0) at the time of ICF signature.
- Active infection, including hepatitis B and/or hepatitis C.
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- Have uncontrolled intercurrent illness, including but not limited to:
- Inadequate bone marrow reserve or organ function.
- History of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to ATG-101.
- Prior organ allograft transplantations.
- Pregnant or nursing females.
- Have a history of another primary malignancy within 3 years prior to starting study treatment. Exceptions are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ, etc.
- In the opinion of the investigator, subject's complications or other conditions may affect protocol compliance or may be unsuitable for participation in the study.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Australia5 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Peter MacCallum Cancer Centre (PMCC) - Victorian Comprehensive Cancer Centre Location (Peter MacCallum Cancer Centre - East Melbourne)
East Melbourne, Victoria, 8006
Austin Health - Olivia Newton-John Cancer Centre
Heidelberg, Victoria, 3084
The Alfred Hospital
Melbourne, Victoria, 3004
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031
United States3 sites
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
University of California San Francisco
San Francisco, California, 94143
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110
About this study
Official title: 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.
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; Dose Expansion Phase: Estimated 100-400 subjects depending on the number of cohorts to be expanded.
- Being tested
- ATG-101
- Keywords
- Solid tumor, lymphoma, bispecific, antibody
- Medical subject headings
- Neoplasm Metastasis, Lymphoma
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 21 days. During the Escalation Phase, 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 |
|---|---|---|
| Single experimental arm for ATG-101 | Experimental | 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
To evaluate the safety of ATG-101. It is the responsibility of the investigator to record and document all AEs (occurring from the first dose of study treatment on C1D1) throughout the study. Clinically significant symptoms and signs related to disease progression will be reported as AEs and meet one or more of the following criteria:
- With clinical symptoms.
- Leading to the change of study treatment (eg, dose adjustment, dose interruption, or study drug withdraw).
- Leading to the change of concomitant treatment (eg, adding, interrupting, or terminating concomitant medications, therapies, or treatments, or any other changes).
Measured: One year after last patient first dose
SAEs
To evaluate the safety of ATG-101. It is the responsibility of the investigator to record and document all SAEs (occurring from the signing of the informed consent form) throughout the study. A SAE is any untoward medical occurrence that occurs at any dose (including SAEs occurred after the ICF is signed and prior to dosing):
- Results in death.
- Is life-threatening (immediate risk of death).
- Requires inpatient hospitalization or prolongation of existing hospitalization.
- Results in persistent or significant disability/incapacity.
- Is a congenital anomaly/birth defect. These should also usually be considered serious. Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsive that do not result in hospitalization; or development of drug dependency or drug abuse.
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
DOR
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
Serum concentrations of ATG-101 and derived PK parameters (for Dose Escalation Phase only)
To characterize the PK of ATG 101 (for Dose Escalation Phase only)
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 posted3 Aug 2021
- Study start15 Dec 2021
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Why it stopped: It is due to the recent changes in the competitor landscape and strategic consideration
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
- Sequential
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antengene Biologics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986865
- Sponsor's protocol ID
- ATG-101-001
- Acronym
- PROBE
- Status last verified
- May 2025
- First submitted
- 19 Jul 2021
- Last updated
- 9 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No