Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors

Solid Tumor Clinical Trial

Official title:

First-in-human (FIH), Open-Label, Phase I (Dose Escalation) Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04111445
• Other study ID #: ADG116-1001
• Status: Terminated
• Phase: Phase 1
• Start date: August 29, 2019
• Est. completion date: April 27, 2021

Study information

• Verified date: September 2021
• Source: Adagene Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 27, 2021
• Est. primary completion date: April 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• ADG116
IV infusion at Day 1 of each cycle

Locations

Country	Name	City	State
United States	NEXT Oncology	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Adagene Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing dose-limiting toxicities		From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years)
Primary	Number of participants experiencing clinical and laboratory adverse events (AEs)		From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years)