Clinical Trials /

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

NCT03707093

Description:

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

Related Conditions:
  • Malignant Solid Tumor
  • Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: ADG106-1001
  • NCT ID: NCT03707093

Conditions

  • Solid Tumors, Non-Hodgkin Lymphoma

Interventions

DrugSynonymsArms
ADG106ADG106 Dose escalation

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
ADG106 Dose escalationExperimental
  • ADG106

Eligibility Criteria

        Inclusion Criteria

          1. Male or female, 18 years of age or older at the time of consent.

          2. Provide written informed consent.

          3. 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.

          4. Life expectancy of 12 weeks or greater.

          5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

          6. At least one measurable lesion per RECIST 1.1 for solid tumors and per Lugano
             Classification for non-Hodgkin lymphoma.

          7. Adequate organ and bone marrow function

          8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test
             within the 7 days prior to study drug administration.

        Exclusion Criteria

          1. Active central nervous system primary or secondary malignancies, active seizure
             disorder, spinal cord compression, or carcinomatous meningitis.

          2. Any active autoimmune disease or documented history of autoimmune disease.

          3. Infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis
             C virus (HCV), except for the following:

          4. History of any non-infectious hepatitis (eg, alcohol or non-alcoholic steatohepatitis,
             drug-related or auto-immune hepatitis).

          5. History of clinically significant cardiac disease.

          6. Uncontrolled current illness.

        8. WOCBP and sexually active fertile men with WOCBP partners who are unwilling or unable to
        use acceptable contraception method to avoid pregnancy.

        9. 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.

        14. 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants experiencing dose-limiting toxicities
Time Frame:2 Cycles (42 days)
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Adagene Inc

Trial Keywords

  • Solid tumor
  • Non-Hodgkin Lymphoma

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