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NCT Number: NCT03707093

Study of CD137 Agonist ADG106 With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma

This is a Phase 1, open-label, dose-escalation, multicenter study of ADG106 in subjects with advanced or metastatic solid tumors and/or relapsed/refractory non-Hodgkin lymphoma. ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb. It binds to the activated human T cells via a T cell receptor CD137. T cell is a kind of lymphocyte (a subtype of white blood cells) that protects bodies by eliminating tumor cells, and normal cells infected with viruses or bacteria. By binding to CD137, the study drug is expected to enhance the activity of activated T cells and thus stimulate a more intense immune attack to kill tumor cells. ADG106 is expected to enhance the activity of activated T cells.

The primary objective of the study is to assess safety and tolerability at increasing dose levels of single agent ADG106 in subjects with advanced or metastatic solid tumors and/or non Hodgkin lymphoma Secondary Objectives

* To characterize the pharmacokinetic (PK) profiles of ADG106 * To evaluate the immunogenicity of ADG106 * To evaluate the potential anti-tumor effect of ADG106 Exploratory Objective To identify the potential biomarkers of ADG106

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Key information

Conditions

Solid Tumors, Non-Hodgkin Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Horizon Oncology Research, Lafayette, Indiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, 18 years of age or older at the time of consent.
  • Provide written informed consent.
  • Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor and/or non-Hodgkin lymphoma who are refractory or relapsed from standard therapy and who have exhausted all available therapies.
  • Life expectancy of 12 weeks or greater.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • At least one measurable lesion per RECIST 1.1 for solid tumors and per Lugano Classification for non-Hodgkin lymphoma.
  • Adequate organ and bone marrow function
  • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days prior to study drug administration.

Exclusion criteria

  • Active central nervous system primary or secondary malignancies, active seizure disorder, spinal cord compression, or carcinomatous meningitis.
  • Any active autoimmune disease or documented history of autoimmune disease.
  • Infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), except for the following:
  • History of any non-infectious hepatitis (eg, alcohol or non-alcoholic steatohepatitis, drug-related or auto-immune hepatitis).
  • History of clinically significant cardiac disease.
  • Uncontrolled current illness.
  • WOCBP and sexually active fertile men with WOCBP partners who are unwilling or unable to use acceptable contraception method to avoid pregnancy.
  • Women who are pregnant at Screening or prior to study drug administration. 10. Women who are breastfeeding. 11. History of significant immune-mediated AE . 13. Systemic use of the following therapies within 28 days prior to the first dose of study drug, or longer.
  • Subjects who got either below treatment:
  • Any previous anti-CD137 mAb (eg, utomilumab, urelumab) treatment.
  • Subject who has received allogenic hematopoietic stem cell transplant or autologous stem cell transplanted.

Treatment and study plan

ADG106

Drug

IV infusion over 60 minutes on Day 1 of each cycle, at doses of 0.03 mg/kg, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg,10 mg/kg or 300mg flat dose depending on cohort at enrollment.

Primary outcomes

  1. Number of participants experiencing dose-limiting toxicities

    Time frame: 2 Cycles (42 days)

  2. Number of participants experiencing clinical and laboratory adverse events (AEs)

    Time frame: First dose to 28 days post last dose

Secondary outcomes

  1. The area under the curve (AUC) of plasma concentration of drug

    Time frame: From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)

  2. Maximum concentration (Cmax)

    Time frame: From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)

  3. Time at which maximum concentration (Tmax)

    Time frame: From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)

  4. Lowest plasma concentration (C[trough])

    Time frame: From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)

Sponsors and collaborators

Lead sponsor

Adagene Inc

Industry

Registry information

Official study title

A Study of CD137 Agonist ADG106 Administered Intravenously in Patients With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 16, 2018
Registry last updated
Oct 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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