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Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04111445
Recruitment Status : Terminated (Study discontinued due to business decision.)
First Posted : October 1, 2019
Last Update Posted : September 10, 2021
Information provided by (Responsible Party):
Adagene Inc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: ADG116 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First-in-human (FIH), Open-Label, Phase I (Dose Escalation) Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
Actual Study Start Date : August 29, 2019
Actual Primary Completion Date : April 27, 2021
Actual Study Completion Date : April 27, 2021

Arm Intervention/treatment
Experimental: ADG116 Drug: ADG116
IV infusion at Day 1 of each cycle

Primary Outcome Measures :
  1. 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) ]
  2. Number of participants experiencing clinical and laboratory adverse events (AEs) [ Time Frame: From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 immune-related adverse events (irAE) 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04111445

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United States, Texas
NEXT Oncology
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Adagene Inc
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Responsible Party: Adagene Inc Identifier: NCT04111445    
Other Study ID Numbers: ADG116-1001
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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