A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors Patients

Completed · Phase 1

Conditions studied: Advanced/Metastatic Solid Tumors

In brief

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. ADG106, a fully human ligand-blocking agonistic anti-CD137 IgG4 mAb, is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG116 in combination with ADG106 or anti-PD-1 provided further support to explore such combinations in clinical settings for better patient responses.

Key facts

Study ID

NCT04501276

Run by

Adagene Inc

People needed

72

Starts

2020-09-23

Expected to finish

2025-11-30

Last updated by the study team

2026-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
• ≥ 18 years of age at the time of informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• Patients with advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists.
• At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
• Adequate organ function.

You may not qualify if…

• Patients who meet any of the following criteria cannot be enrolled:
• Pregnant or breastfeeding females.
• Childbearing potential who does not agree to the use of contraception during the treatment period..
• Treatment with any investigational drug within washout period.
• Grade ≥ 3 immune-related AEs (irAEs) or irAE that lead to discontinuation of prior immunotherapy.
• Central nervous system disease involvement
• History or risk of autoimmune disease.
• History of life-threatening hypersensitivity or known to be allergic to protein drugs or recombinant proteins or any ingredients contained in the ADG116 drug formulation.
• Patients requiring systemic treatment with corticosteroids
• Patients receiving granulocyte colony stimulating factor (G-CSF), within 14 days prior to the first dose of the study drug.
• Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).
• Major surgery within 4 weeks prior to the first dose of the study drug.
• Has had an allogeneic tissue/solid organ transplant.

Where it is running

• Next Oncology — San Antonio, Texas, United States
• Ashford Cancer Centre Research — Kurralta Park, Australia
• Cabrini Hospital — Malvern, Australia
• Macquarie University — Sydney, Australia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.