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Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT04111445
Recruitment Status : Active, not recruiting
First Posted : October 1, 2019
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Adagene Inc

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
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 : January 6, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: ADG116 Drug: ADG116
IV infustion at Day 1 of each cycle


Outcome Measures
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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) ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04111445


Locations
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United States, Texas
NEXT Oncology
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Adagene Inc
More Information
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Responsible Party: Adagene Inc
ClinicalTrials.gov Identifier: NCT04111445    
Other Study ID Numbers: ADG116-1001
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020

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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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Neoplasms