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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03707093
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Adagene Inc

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Solid Tumors, Non-Hodgkin Lymphoma Drug: ADG106 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of CD137 Agonist ADG106 Administered Intravenously in Patients With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma
Actual Study Start Date : September 17, 2018
Estimated Primary Completion Date : April 27, 2021
Estimated Study Completion Date : September 27, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: ADG106 Dose escalation Drug: ADG106
IV infusion over 60 minutes on Day 1 of each cycle, at doses of 0.03 mg/kg, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, or 10 mg/kg depending on cohort at enrollment.




Primary Outcome Measures :
  1. Number of participants experiencing dose-limiting toxicities [ Time Frame: 2 Cycles (42 days) ]
  2. Number of participants experiencing clinical and laboratory adverse events (AEs) [ Time Frame: First dose to 28 days post last dose ]

Secondary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]


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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT03707093


Contacts
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Contact: Xiaohong She, Master +8618260157039 kristine_she@adagene.com

Locations
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United States, Indiana
Horizon Oncology Research Not yet recruiting
Lafayette, Indiana, United States, 47905
Contact: Wael Harb, MD       wharb@horizonbioadvance.com   
United States, Texas
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Sarah Gomez    210-595-5670      
Sponsors and Collaborators
Adagene Inc
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Responsible Party: Adagene Inc
ClinicalTrials.gov Identifier: NCT03707093    
Other Study ID Numbers: ADG106-1001
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adagene Inc:
Solid tumor
Non-Hodgkin Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases