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Not recruiting
Phase 1

ATG-101

Sponsor:

Antengene Biologics Limited

Code:

NCT04986865

Conditions

Advanced Solid Tumor

Metastatic Solid Tumor

Mature B-cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ATG-101

Study Details

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.

Conditions

Advanced Solid Tumor

Metastatic Solid Tumor

Mature B-cell Non-Hodgkin Lymphoma

Study ID

NCT04986865

Start date

Dec 15, 2021

Status verified date

Feb, 2024

Completion date

Jan 1, 2026

Anticipated

Primary completion date

Oct 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single experimental arm for ATG-101

Subjects with advanced or metastatic solid tumors and mature B-NHLs will be enrolled.

Interventions

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.

Primary outcome measure

  • AEs [ Time Frame: One year after last patient first dose ]
  • SAEs [ Time Frame: One year after last patient first dose ]
  • DLT (for Dose Escalation Phase only) [ Time Frame: One year after last patient first dose ]

Central Contacts and Locations

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Bridget Keenan, PhD

Washington University School of Medicine in St. Louis

Recruiting

Saint Louis, Missouri, United States, 63110

Principal Investigator:

Davis Andrew

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Principal Investigator:

Anthony Olszanski

More Information

Sponsor

Antengene Biologics Limited

Last update posted

Sep 19, 2024

Last verified

Feb, 2024

Keywords

  • Solid tumor, lymphoma, bispecific, antibody

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-15. This information was provided to ClinicalTrials.gov by Antengene Biologics Limited on 2024-09-19.