Treatment of advanced metastatic solid tumors with ADG206

A First-in-Human (FIH), Open-Label, Phase 1 Study of ADG206, a CD137 Agonist Antibody, in Subjects With Advanced/Metastatic Solid Tumors

This study is testing a new treatment called ADG206 to see if it can help people with advanced solid tumors who have run out of other treatment options.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Adagene Inc (Industry-sponsored)
• Locations: 2 sites (Kurralta Park, South Australia and 1 other locations)
• Trial ID: NCT05614258 on ClinicalTrials.gov

What this trial studies

This Phase 1, open-label, multicenter trial evaluates the safety, tolerability, pharmacokinetics, and preliminary efficacy of ADG206, a prodrug monoclonal antibody targeting CD137, in patients with advanced or metastatic solid tumors. The study involves a sequential dose escalation approach to determine the optimal dosing levels for patients who have exhausted standard treatment options. Participants will be monitored for adverse effects and treatment responses throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults with advanced or metastatic solid tumors that have progressed after all standard therapies.

Not a fit: Patients with thymic tumors or those currently undergoing other anti-tumor therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited alternatives.

How similar studies have performed: While this approach is novel in its specific application, similar immunotherapy strategies targeting CD137 have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
* Subjects with advanced or metastatic solid tumors (except thymic tumors), which have progressed after all standard therapies, or no further standard therapies exists.
* At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
* Adequate organ function.
* Woman of childbearing potential must agree to use 2 methods of acceptable contraception from screening until 6 months after the last dose of study drug.
* Male subjects who are sexually active with a female partner of childbearing potential must agree to use a barrier contraception.

Exclusion Criteria:

* Subjects within washout period of other anti-tumor therapies. .
* History of prior malignancy other than the cancer under treatment in the study.
* Major trauma or major surgery within 4 weeks before the first dose of study drug.
* Serious nonhealing wound, ulcer, or bone fracture.
* History of significant immune-mediated AE.
* Central nervous system (CNS) disease involvement.
* Any evidence of underlying severe liver dysfunction.
* Prior organ allograft transplantations or allogeneic bone marrow, cord blood or peripheral blood stem cell transplantation.
* Clinically significant cardiac disease with insufficient cardiac function.
* Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
* Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS).
* Infection of hepatitis B virus (HBV), or hepatitis C virus (HCV) (unless the disease is clinically controlled) .
* History or risk of autoimmune disease.
* Subjects with active severe lung infection or with a history of interstitial lung diseases, noninfectious pneumonitis, active pulmonary tuberculosis, or evidence of active pneumonitis. Clinically significant and unmanageable ascites defined as requiring constant therapeutic paracentesis.
* Any serious underlying issue that would limit compliance with study requirements, impair the ability of the subject to understand informed consent.
* Known hypersensitivity, allergies, or intolerance to immunoglobulins or to any excipient contained in ADG206.
* Pregnant, lactating, or breastfeeding.

Where this trial is running

Kurralta Park, South Australia and 1 other locations

• Ashford Cancer Centre Research — Kurralta Park, South Australia, Australia (Recruiting)
• Monash Health — Clayton, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Xiaohong She

Conditions Advanced/Metastatic Solid Tumors