Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors

NCT04111445 | Terminated Phase 1 FDA Drug

• 1 other identifier: ADG116-1001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (1)

ADG116

EXPERIMENTAL

Drug: ADG116

Interventions

ADG116 DRUG

IV infusion at Day 1 of each cycle

ADG116

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adagene Inc: lead

Study Sites (1)

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: October 1, 2019
• Study Start: August 29, 2019
• Primary Completion: April 27, 2021
• Study Completion: April 27, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-09

Locations

US (1)