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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.
 
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

Tracking Information
First Submitted Date  ICMJE September 11, 2019
First Posted Date  ICMJE October 1, 2019
Last Update Posted Date August 4, 2020
Actual Study Start Date  ICMJE January 6, 2020
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
  • 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) ]
  • 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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
Official Title  ICMJE First-in-human (FIH), Open-Label, Phase I (Dose Escalation) Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE Drug: ADG116
IV infustion at Day 1 of each cycle
Study Arms  ICMJE Experimental: ADG116
Intervention: Drug: ADG116
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 30, 2019)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04111445
Other Study ID Numbers  ICMJE ADG116-1001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adagene Inc
Study Sponsor  ICMJE Adagene Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Adagene Inc
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP