- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04986865
A Study ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas (PROBE)
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 Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Sunny He
- Phone Number: 8618721521865
- Email: sunny.he@antengene.com
Study Contact Backup
- Name: Doris Tao
- Email: doris.tao@antengene.com
Study Locations
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New South Wales
-
Randwick, New South Wales, Australia, 2031
- Recruiting
- Scientia Clinical Research Ltd
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Contact:
- Charlotte Lemech
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Principal Investigator:
- Charlotte Lemech
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South Australia
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Adelaide, South Australia, Australia, 5000
- Recruiting
- Royal Adelaide Hospital
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Principal Investigator:
- Michael Brown
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Contact:
- Michae Brown, MD
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Victoria
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East Melbourne, Victoria, Australia, 8006
- Recruiting
- Peter MacCallum Cancer Centre (PMCC) - Victorian Comprehensive Cancer Centre Location (Peter MacCallum Cancer Centre - East Melbourne)
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Principal Investigator:
- Annette Lim
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Contact:
- Annette Lim
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Heidelberg, Victoria, Australia, 3084
- Recruiting
- Austin Health - Olivia Newton-John Cancer Centre
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Contact:
- Hui Gan
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Principal Investigator:
- Hui Gan
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Melbourne, Victoria, Australia, 3004
- Recruiting
- The Alfred Hospital
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Principal Investigator:
- Mark Voskoboynik
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Contact:
- Mark Voskoboynik
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California
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San Francisco, California, United States, 94143
- Recruiting
- University of California San Francisco
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Contact:
- Diamond Luong
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Principal Investigator:
- Bridget Keenan, PhD
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Missouri
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Saint Louis, Missouri, United States, 63110
- Recruiting
- Washington University School of Medicine in St. Louis
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Contact:
- Maximilian Stroyeck
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Principal Investigator:
- Davis Andrew
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Recruiting
- Fox Chase Cancer Center
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Principal Investigator:
- Anthony Olszanski
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Contact:
- Anthony Olszanski, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single experimental arm for ATG-101
Subjects with advanced or metastatic solid tumors and mature B-NHLs will be enrolled.
|
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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DLT (for Dose Escalation Phase only)
Time Frame: One year after last patient first dose
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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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One year after last patient first dose
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AEs
Time Frame: One year after last patient first dose
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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:
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One year after last patient first dose
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SAEs
Time Frame: One year after last patient first dose
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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):
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One year after last patient first dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR
Time Frame: One year after last patient first dose
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To evaluate preliminary anti tumor activity of ATG-101
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One year after last patient first dose
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DCR
Time Frame: One year after last patient first dose
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To evaluate preliminary anti tumor activity of ATG-101
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One year after last patient first dose
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PFS
Time Frame: One year after last patient first dose
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To evaluate preliminary anti tumor activity of ATG-101
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One year after last patient first dose
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OS
Time Frame: One year after last patient first dose
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To evaluate preliminary anti tumor activity of ATG-101
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One year after last patient first dose
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The incidence of ADA and NAb
Time Frame: One year after last patient first dose
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To evaluate the immunogenicity of ATG-101
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One year after last patient first dose
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DOR
Time Frame: One year after last patient first dose
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To evaluate preliminary anti tumor activity of ATG-101
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One year after last patient first dose
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Serum concentrations of ATG-101 and derived PK parameters (for Dose Escalation Phase only)
Time Frame: One year after last patient first dose
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To characterize the PK of ATG 101 (for Dose Escalation Phase only)
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One year after last patient first dose
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ATG-101-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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