Clinical trial · Interventional
Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
First-in-human (FIH), Open-Label, Phase I (Dose Escalation) Study of ADG116 in Patients With Advanced/Metastatic Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study discontinued due to business decision.
Summary
Brief summary (as posted)
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
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADG116 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ADG116
- interventionNames
- Drug: ADG116
Primary outcomes (2)
- measure
- Number of participants experiencing dose-limiting toxicities
- timeFrame
- From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years)
- measure
- Number of participants experiencing clinical and laboratory adverse events (AEs)
- timeFrame
- From first dose of ADG116 (Week 1 Day 1) until 30days after the last ADG116 injection (up to 2 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available