Clinical Trials /

Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors

NCT04111445

Description:

This is a FIH, open-label, Phase I dose-escalation study of ADG116 in subjects with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. ADG 116 administered intravenously (IV) over a period of 60-90 minutes. The study planned to treated 42 patients.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
  • Official Title: First-in-human (FIH), Open-Label, Phase I (Dose Escalation) Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: ADG116-1001
  • NCT ID: NCT04111445

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
ADG116ADG116

Purpose

This is a FIH, open-label, Phase I dose-escalation study of ADG116 in subjects with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. ADG 116 administered intravenously (IV) over a period of 60-90 minutes. The study planned to treated 42 patients.

Trial Arms

NameTypeDescriptionInterventions
ADG116Experimental
  • ADG116

Eligibility Criteria

        Inclusion Criteria

          -  Male or female, 18-75 years of age at the time of consent.

          -  Provide written informed consent.

          -  Subjects with advanced and/or metastatic histologically or cytologically confirmed
             solid tumor who have not responded or progressed after standard therapies or for whom
             no further standard therapy exists or standard therapy is not available

          -  Patients who are refractory or relapsed to prior anti-CTLA4 checkpoint inhibitors will
             also be recruited if they meet all eligibility criteria.

          -  Eastern Cooperative Oncology Group (ECOG) performance status < 2.

          -  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

        Exclusion Criteria:

          -  Pregnant or nursing females.

          -  Treatment with any investigational drug within 4 weeks prior to the first dose of
             study drug

          -  Grade ≥ 3 irAEs or irAE that lead to discontinuation of prior immunotherapy. Untreated
             or uncontrolled central nervous system (CNS) tumors or metastases

          -  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)

          -  Subjects requiring systemic treatment with corticosteroids or other immunosuppressive
             medications within 21 days before the planned first dose of study drug.

          -  Current or prior history of pneumonitis, hepatitis, nephritis, colitis or thyroiditis.
             Peripheral neuropathy ≥ Grade 2.

          -  History of clinically significant cardiac disease.

          -  Uncontrolled current illness.
      
Maximum Eligible Age:75 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants experiencing dose-limiting toxicities
Time Frame:From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Adagene Inc

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