Back to resultsA Study ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas (PROBE)
Primary Purpose
Advanced Solid Tumor, Metastatic Solid Tumor, Mature B-cell Non-Hodgkin Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ATG-101
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Solid Tumor
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- University of California San Francisco
- University of Colorado Hospital
- Northwestern University
- Fox Chase Cancer CenterRecruiting
- Scientia Clinical Research LtdRecruiting
- Royal Adelaide HospitalRecruiting
- Peter MacCallum Cancer Centre (PMCC) - Victorian Comprehensive Cancer Centre Location (Peter MacCallum Cancer Centre - East Melbourne)Recruiting
- Austin Health - Olivia Newton-John Cancer CentreRecruiting
- The Alfred HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ATG-101
Arm Description
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.
Outcomes
Primary Outcome Measures
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).
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.
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.
Secondary Outcome Measures
ORR
To evaluate preliminary anti tumor activity of ATG-101
DOR
To evaluate preliminary anti tumor activity of ATG-101
DCR
To evaluate preliminary anti tumor activity of ATG-101
PFS
To evaluate preliminary anti tumor activity of ATG-101
OS
To evaluate preliminary anti tumor activity of ATG-101
The incidence of ADA and NAb
To evaluate the immunogenicity of ATG-101
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)
Full Information
NCT ID
NCT04986865
First Posted
July 19, 2021
Last Updated
September 26, 2023
Sponsor
Antengene Biologics Limited
1. Study Identification
Unique Protocol Identification Number
NCT04986865
Brief Title
A Study ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
Acronym
PROBE
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Antengene Biologics Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 100-400 subjects depending on the number of cohorts to be expanded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor, Metastatic Solid Tumor, Mature B-cell Non-Hodgkin Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
482 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ATG-101
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ATG-101
Intervention Description
ATG-101 will be administered intravenously once every 21 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.
Primary Outcome Measure Information:
Title
AEs
Description
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).
Time Frame
One year after last patient first dose
Title
SAEs
Description
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.
Time Frame
One year after last patient first dose
Title
DLT (for Dose Escalation Phase only)
Description
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
Secondary Outcome Measure Information:
Title
ORR
Description
To evaluate preliminary anti tumor activity of ATG-101
Time Frame
One year after last patient first dose
Title
DOR
Description
To evaluate preliminary anti tumor activity of ATG-101
Time Frame
One year after last patient first dose
Title
DCR
Description
To evaluate preliminary anti tumor activity of ATG-101
Time Frame
One year after last patient first dose
Title
PFS
Description
To evaluate preliminary anti tumor activity of ATG-101
Time Frame
One year after last patient first dose
Title
OS
Description
To evaluate preliminary anti tumor activity of ATG-101
Time Frame
One year after last patient first dose
Title
The incidence of ADA and NAb
Description
To evaluate the immunogenicity of ATG-101
Time Frame
One year after last patient first dose
Title
Serum concentrations of ATG-101 and derived PK parameters (for Dose Escalation Phase only)
Description
To characterize the PK of ATG 101 (for Dose Escalation Phase only)
Time Frame
One year after last patient first dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sunny He
Phone
15000411862
Email
sunny.he@antengene.com
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Zou
Email
stephanie.zou@antengene.com
Facility Information:
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Melisko, PhD
Facility Name
University of Colorado Hospital
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80309
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Flaig, PhD
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devalingam Mahalingam, PhD
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Olszanski, PhD
Facility Name
Scientia Clinical Research Ltd
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlotte Lemech
First Name & Middle Initial & Last Name & Degree
Charlotte Lemech
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michae Brown, PhD
Facility Name
Peter MacCallum Cancer Centre (PMCC) - Victorian Comprehensive Cancer Centre Location (Peter MacCallum Cancer Centre - East Melbourne)
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
8006
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jayesh Desai
First Name & Middle Initial & Last Name & Degree
Jayesh Desai
Facility Name
Austin Health - Olivia Newton-John Cancer Centre
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Gan
First Name & Middle Initial & Last Name & Degree
Hui Gan
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Voskoboynik
First Name & Middle Initial & Last Name & Degree
Mark Voskoboynik
12. IPD Sharing Statement
Learn more about this trial
A Study ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas
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