Clinical trial · Interventional
Study of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Solid Tumors
A Phase I, Open-label, Uncontrolled, Dose Escalation Study to Evaluate the Tolerability and Safety of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Advanced or Metastatic Solid Tumors
NCT06535009CI-TRIAL-00090543terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to strategic reasons
Summary
Brief summary (as posted)
This study is dose escalation study to evaluate the tolerability and safety of ONO-7914 alone and in combination with ONO-4538 in patients with advanced or metastatic solid tumors
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ONO-4538 | Drug | Nivolumab | ALIAS |
| ONO-7914 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ONO-7914
- interventionNames
- Drug: ONO-7914
- type
- EXPERIMENTAL
- label
- ONO-7914+ONO-4538
- interventionNames
- Drug: ONO-7914
- Drug: ONO-4538
Primary outcomes (2)
- measure
- Dose Limiting Toxicity
- timeFrame
- 28 days
- measure
- Adverse Events as assessed by CTCAE v5.0
- timeFrame
- Up to 28 days after the completion of treatment period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with advanced or metastatic solid tumor 2. Patients with ECOG performance status of 0 or 1 3. Patients with a life expectancy of at least 3 months Exclusion Criteria: 1. Patients with severe complication 2. Patients judged to be incapable of providing consent for reasons such as concurrent dementia
References
Publications (0)
Data not yet available
No reference posted for this study.