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RecruitingLast updated: 7 February 2024

PROBE: This phase I trial is investigating how safe and tolerable a new targeted therapy (ATG-101) is in people with metastatic or advanced solid cancers, and mature B-cell Non-Hodgkin LymphomaA First-in-Human Phase I Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas

Clinical summary

Summary

This trial has two phases: A Dose Escalation Phase and a Dose Expansion Phase. In the Dose Escalation Phase, ATG-101 will be administered intravenously (via IV) once every 21 days in increasing doses until the recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD) or biologically optimal dose is determined. In the Dose Expansion Phase, ATG-101 will be administered at the dose level determined in the Dose Escalation Phase.

Conditions

This trial is treating patients with metastatic or advanced solid cancers and mature B-cell Non-Hodgkin Lymphoma

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

PROBE

More information

Trial Identifiers

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Trial sponsor

Antengene Biologics Limited

Scientific 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

Eligibility

Inclusion

  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

  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.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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