Non Hodgkin Lymphoma Clinical Trial

A Study ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas

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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Full 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.

View Eligibility Criteria

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

40

Study ID:

NCT04986865

Recruitment Status:

Recruiting

Sponsor:

Antengene Biologics Limited

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There are 8 Locations for this study

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University of California San Francisco
San Francisco California, 94143, United States More Info
Diamond Luong
Contact
Bridget Keenan, PhD
Principal Investigator
Washington University School of Medicine in St. Louis
Saint Louis Missouri, 63110, United States More Info
Maximilian Stroyeck
Contact
Davis Andrew
Principal Investigator
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States More Info
Anthony Olszanski, MD
Contact
Anthony Olszanski
Principal Investigator
Scientia Clinical Research Ltd
Randwick New South Wales, 2031, Australia More Info
Charlotte Lemech
Contact
Charlotte Lemech
Principal Investigator
Royal Adelaide Hospital
Adelaide South Australia, 5000, Australia More Info
Michae Brown, MD
Contact
Michael Brown
Principal Investigator
Peter MacCallum Cancer Centre (PMCC) - Victorian Comprehensive Cancer Centre Location (Peter MacCallum Cancer Centre - East Melbourne)
East Melbourne Victoria, 8006, Australia More Info
Annette Lim
Contact
Annette Lim
Principal Investigator
Austin Health - Olivia Newton-John Cancer Centre
Heidelberg Victoria, 3084, Australia More Info
Hui Gan
Contact
Hui Gan
Principal Investigator
The Alfred Hospital
Melbourne Victoria, 3004, Australia More Info
Mark Voskoboynik
Contact
Mark Voskoboynik
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

40

Study ID:

NCT04986865

Recruitment Status:

Recruiting

Sponsor:


Antengene Biologics Limited

How clear is this clinincal trial information?

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