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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04986865
Registration number
NCT04986865
Ethics application status
Date submitted
19/07/2021
Date registered
3/08/2021
Date last updated
12/02/2024
Titles & IDs
Public title
A Study ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
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Scientific 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
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Secondary ID [1]
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ATG-101-001
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Universal Trial Number (UTN)
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Trial acronym
PROBE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor
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Metastatic Solid Tumor
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Mature B-cell Non-Hodgkin Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ATG-101
Experimental: Single experimental arm for ATG-101 - Subjects with advanced or metastatic solid tumors and mature B-NHLs will be enrolled.
Treatment: Drugs: ATG-101
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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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AEs
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Assessment method [1]
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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).
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Timepoint [1]
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One year after last patient first dose
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Primary outcome [2]
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SAEs
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Assessment method [2]
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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.
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Timepoint [2]
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One year after last patient first dose
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Primary outcome [3]
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DLT (for Dose Escalation Phase only)
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Assessment method [3]
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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.
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Timepoint [3]
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One year after last patient first dose
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Secondary outcome [1]
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ORR
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Assessment method [1]
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To evaluate preliminary anti tumor activity of ATG-101
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Timepoint [1]
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One year after last patient first dose
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Secondary outcome [2]
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DOR
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Assessment method [2]
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To evaluate preliminary anti tumor activity of ATG-101
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Timepoint [2]
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One year after last patient first dose
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Secondary outcome [3]
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DCR
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Assessment method [3]
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To evaluate preliminary anti tumor activity of ATG-101
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Timepoint [3]
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One year after last patient first dose
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Secondary outcome [4]
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PFS
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Assessment method [4]
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To evaluate preliminary anti tumor activity of ATG-101
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Timepoint [4]
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One year after last patient first dose
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Secondary outcome [5]
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OS
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Assessment method [5]
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To evaluate preliminary anti tumor activity of ATG-101
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Timepoint [5]
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One year after last patient first dose
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Secondary outcome [6]
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The incidence of ADA and NAb
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Assessment method [6]
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To evaluate the immunogenicity of ATG-101
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Timepoint [6]
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One year after last patient first dose
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Secondary outcome [7]
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Serum concentrations of ATG-101 and derived PK parameters (for Dose Escalation Phase only)
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Assessment method [7]
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To characterize the PK of ATG 101 (for Dose Escalation Phase only)
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Timepoint [7]
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One year after last patient first dose
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Eligibility
Key inclusion criteria
1. Provision of signed and dated, written informed consent prior to any study-specific
procedures, sampling, and analyses.
2. Aged at least 18 years as of the date of consent.
3. 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.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
5. Female and male subjects should be using adequate contraceptive measures as requested.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Subjects with CNS tumors or known CNS metastases will be excluded.
2. Prior ATG-101 administration or a 4-1BB agonist.
3. Prior anti-tumor systemic therapy within 21 days(a period of 5 'half- lives') of the
first dose of study treatment.
4. Radiotherapy with a wide field of radiation within 28 days.
5. With the exception of alopecia, any unresolved toxicities from prior therapy greater
than Grade 1 (CTCAE v5.0) at the time of ICF signature.
6. Active infection, including hepatitis B and/or hepatitis C.
7. Have uncontrolled intercurrent illness, including but not limited to:
8. Inadequate bone marrow reserve or organ function.
9. History of hypersensitivity or history of allergic reactions attributed to drugs with
a similar chemical or biologic structure or class to ATG-101.
10. Prior organ allograft transplantations.
11. Pregnant or nursing females.
12. 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.
13. 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/12/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2026
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Scientia Clinical Research Ltd - Randwick
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Recruitment hospital [2]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [3]
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Peter MacCallum Cancer Centre (PMCC) - Victorian Comprehensive Cancer Centre Location (Peter MacCallum Cancer Centre - East Melbourne) - East Melbourne
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Recruitment hospital [4]
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Austin Health - Olivia Newton-John Cancer Centre - Heidelberg
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Recruitment hospital [5]
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The Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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8006 - East Melbourne
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Missouri
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Country [3]
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United States of America
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State/province [3]
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Pennsylvania
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Antengene Biologics Limited
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04986865
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Sunny He
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Address
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Country
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Phone
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8618721521865
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04986865
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