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

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Antengene

Status and phase

Enrolling
Phase 1

Conditions

Advanced Solid Tumor
Mature B-cell Non-Hodgkin Lymphoma
Metastatic Solid Tumor

Treatments

Drug: ATG-101

Study type

Interventional

Funder types

Industry

Identifiers

NCT04986865
ATG-101-001

Details and patient eligibility

About

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.

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

40 participants in 1 patient group

Single experimental arm for ATG-101
Experimental group
Description:
Subjects with advanced or metastatic solid tumors and mature B-NHLs will be enrolled.
Treatment:
Drug: ATG-101

Trial contacts and locations

8

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Central trial contact

Doris Tao; Sunny He

Data sourced from clinicaltrials.gov

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