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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. 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: NCT04501276
Recruitment Status : Not yet recruiting
First Posted : August 6, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Adagene Inc

Brief Summary:
This is a Phase 1, open-label, dose escalation study in patients 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 is planned to treat up to 60 patients.

Condition or disease Intervention/treatment Phase
Advanced/Metastatic Solid Tumors Drug: ADG116 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose Escalation Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
Estimated Study Start Date : August 28, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : February 28, 2023

Arm Intervention/treatment
Experimental: ADG116 Dose Escalation Level 1 Drug: ADG116
ADG116 will be administered IV over 60-90 minutes with planned doses every three weeks for the first 4 cycles. If no intolerable toxicities occur during the first consecutive four treatment cycles, administration of ADG116 may continue every 12 weeks for a total duration of up to 2 years per agreement with the Investigator and the Sponsor.

Experimental: ADG116 Dose Escalation Level 2 Drug: ADG116
ADG116 will be administered IV over 60-90 minutes with planned doses every three weeks for the first 4 cycles. If no intolerable toxicities occur during the first consecutive four treatment cycles, administration of ADG116 may continue every 12 weeks for a total duration of up to 2 years per agreement with the Investigator and the Sponsor.

Experimental: ADG116 Dose Escalation Level 3 Drug: ADG116
ADG116 will be administered IV over 60-90 minutes with planned doses every three weeks for the first 4 cycles. If no intolerable toxicities occur during the first consecutive four treatment cycles, administration of ADG116 may continue every 12 weeks for a total duration of up to 2 years per agreement with the Investigator and the Sponsor.

Experimental: ADG116 Dose Escalation Level 4 Drug: ADG116
ADG116 will be administered IV over 60-90 minutes with planned doses every three weeks for the first 4 cycles. If no intolerable toxicities occur during the first consecutive four treatment cycles, administration of ADG116 may continue every 12 weeks for a total duration of up to 2 years per agreement with the Investigator and the Sponsor.

Experimental: ADG116 Dose Escalation Level 5 Drug: ADG116
ADG116 will be administered IV over 60-90 minutes with planned doses every three weeks for the first 4 cycles. If no intolerable toxicities occur during the first consecutive four treatment cycles, administration of ADG116 may continue every 12 weeks for a total duration of up to 2 years per agreement with the Investigator and the Sponsor.

Experimental: ADG116 Dose Escalation Level 6 Drug: ADG116
ADG116 will be administered IV over 60-90 minutes with planned doses every three weeks for the first 4 cycles. If no intolerable toxicities occur during the first consecutive four treatment cycles, administration of ADG116 may continue every 12 weeks for a total duration of up to 2 years per agreement with the Investigator and the Sponsor.

Experimental: ADG116 Dose Escalation Level 7 Drug: ADG116
ADG116 will be administered IV over 60-90 minutes with planned doses every three weeks for the first 4 cycles. If no intolerable toxicities occur during the first consecutive four treatment cycles, administration of ADG116 may continue every 12 weeks for a total duration of up to 2 years per agreement with the Investigator and the Sponsor.

Experimental: ADG116 Dose Escalation Level 8 Drug: ADG116
ADG116 will be administered IV over 60-90 minutes with planned doses every three weeks for the first 4 cycles. If no intolerable toxicities occur during the first consecutive four treatment cycles, administration of ADG116 may continue every 12 weeks for a total duration of up to 2 years per agreement with the Investigator and the Sponsor.

Experimental: ADG116 Dose Escalation Level 9 Drug: ADG116
ADG116 will be administered IV over 60-90 minutes with planned doses every three weeks for the first 4 cycles. If no intolerable toxicities occur during the first consecutive four treatment cycles, administration of ADG116 may continue every 12 weeks for a total duration of up to 2 years per agreement with the Investigator and the Sponsor.




Primary Outcome Measures :
  1. Number of participants experiencing dose-limiting toxicities escalating dose levels in adults with advanced / metastatic solid tumors [ Time Frame: From first dose of ADG116 (Week 1 Day 1) until 21 days ]
  2. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: From first dose of ADG116 (Week 1 Day 1) to 28 days post last dose ]

Secondary Outcome Measures :
  1. Area under the time concentration curve (AUC) from time zero to infinity (AUC0-inf) [ Time Frame: From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years) ]
  2. Maximum (peak) plasma 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 to maximum (peak) plasma 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. Trough plasma concentration (Ctrough) [ 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

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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:

  • ≥18 years of age at the time of informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 with no deterioration over the previous 2 weeks.
  • Patients with advanced or metastatic solid tumors, confirmed by histopathology, who have progressed after all standard therapies, or for whom no further standard therapy exists. Patients who have declined standard therapy or have no access to standard therapy may be enrolled and the reasons for lack of access need to be documented.
  • Patients who are refractory or relapsed to prior anti-CTLA4 checkpoint inhibitors or anti Programmed cell death protein 1 (PD 1) will also be recruited if they meet all eligibility criteria.
  • Adequate hematologic function
  • Adequate renal function
  • Previous antitumor therapy (including endocrine, chemoradiotherapy/ radiotherapy, targeted therapy, or immunotherapy) that has ended at least 4 weeks prior to administration of ADG116.
  • Previous adverse events have been improved to baseline or ≤ Grade 1 NCI CTCAE v5.0 (except for patients with alopecia).

Exclusion Criteria:

  • Pregnant or breastfeeding females.
  • Treatment with any investigational drug within 4 weeks prior to the first dose of study drug.
  • Grade ≥ 3 immune-related AEs (irAEs) or irAE that lead to discontinuation of prior immunotherapy.
  • Patients with active autoimmune disease or a documented medical history of autoimmune disease.
  • Patients requiring systemic treatment with corticosteroids or other immunosuppressive medications within 21 days before the planned first dose of study drug.
  • Active viral (any etiology) hepatitis patient are excluded.
  • Known human immunodeficiency virus (HIV) positive status.
  • Patients with any type of primary immunodeficiency or autoimmune disorder requiring treatment.
  • Major surgery within 4 weeks prior to the first dose of the study drug.
  • Clinically significant cardiac conditions.
  • Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose of study drug.
  • Any known, documented, or suspected history of illicit substance abuse.
  • Any other disease or clinically significant abnormality in laboratory parameters.

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): NCT04501276


Contacts
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Contact: Kristine She 4088389296 kristine_she@adagene.com
Contact: Hua Gong 8586954033 hua_gong@adagene.com

Sponsors and Collaborators
Adagene Inc
Additional Information:
Publications:

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Responsible Party: Adagene Inc
ClinicalTrials.gov Identifier: NCT04501276    
Other Study ID Numbers: ADG116-1003
First Posted: August 6, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adagene Inc:
Advanced/Metastatic Solid Tumors
Additional relevant MeSH terms:
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Neoplasms