Clinical trial · Interventional
ONO-4538 Phase I Study in Patients With Solid Tumor
ONO-4538 Multicenter, Open-label, Uncontrolled, Phase I Study in Solid Tumor
NCT02261285CI-TRIAL-00076786completedPhase 1Results postedClinicalTrials.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)
The objective of the study is to investigate the pharmacokinetics of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available.
Conditions
Conditions (2)
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 Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Recurrent Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ONO-4538 | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- ONO-4538 1mg/kg
- description
- ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, single dose
- interventionNames
- Drug: ONO-4538
- type
- EXPERIMENTAL
- label
- ONO-4538 3mg/kg
- description
- ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, single dose
- interventionNames
- Drug: ONO-4538
- type
- EXPERIMENTAL
- label
- ONO-4538 10mg/kg
- description
- ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, single dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female ≥ 20 years of age * Histologically or cytologically confirmed solid tumor * Patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available * ECOG Performance Status is 0 to 1 Exclusion Criteria: * Current or prior severe hypersensitivity to another antibody product * Multiple primary cancers
References
Publications (1)
- DERIVEDLee KW, Lee DH, Kang JH, Park JO, Kim SH, Hong YS, Kim ST, Oh DY, Bang YJ. Phase I Pharmacokinetic Study of Nivolumab in Korean Patients with Advanced Solid Tumors. Oncologist. 2018 Feb;23(2):155-e17. doi: 10.1634/theoncologist.2017-0528. Epub 2017 Nov 20. PMID 29158363