Clinical trial · Interventional
Study of ADG206 in Subjects With Advanced/Metastatic Solid Tumors
A First-in-Human (FIH), Open-Label, Phase 1 Study of ADG206, a CD137 Agonist Antibody, in Subjects With Advanced/Metastatic Solid Tumors
NCT05614258CI-TRIAL-00100390active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
ADG206 is an activatable prodrug form of a fully human monoclonal antibody (mAb) of the immunoglobulin G1 (IgG1) subclass that specifically targets cluster of differentiation 137 (CD137) (also known as 4-1BB) as a co-stimulatory receptor agonist for the treatment of advanced malignancies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced/Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADG206 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ADG206 dose escalation
- interventionNames
- Drug: ADG206
Primary outcomes (5)
- measure
- Number of participants experiencing dose-limiting toxicities escalating dose levels
- timeFrame
- At the end of Cycle 1 (each cycle is 21 days)
- measure
- Number of participants with adverse events (AE)
- timeFrame
- At the end of 90 days post last dose (each cycle is 21 days)
- measure
- Maximum administered dose (MAD) of ADG206
- timeFrame
- At the end of the last dose (each cycle is 21 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDSingh R, Kim YH, Lee SJ, Eom HS, Choi BK. 4-1BB immunotherapy: advances and hurdles. Exp Mol Med. 2024 Feb;56(1):32-39. doi: 10.1038/s12276-023-01136-4. Epub 2024 Jan 4. PMID 38172595