Clinical trial · Interventional
A Study of ONO-7429 in Participants With Unresectable Advanced or Recurrent Solid Tumors
A Phase 1, Open-label, Dose Escalation Study to Investigate the Safety and Tolerability of ONO-7429 in Participants With Unresectable Advanced or Recurrent Solid Tumors
NCT07787208CI-TRIAL-00123955recruitingPhase 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)
This study is to evaluate the tolerability and safety of ONO-7429 in participants with unresectable advanced or recurrent 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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ONO-7429 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ONO-7429
- interventionNames
- Drug: ONO-7429
Primary outcomes (2)
- measure
- Dose-limiting toxicities（DLT）
- timeFrame
- From first dose through completion of the DLT evaluation period (approximately 21 days)
- measure
- Adverse event (AE)
- timeFrame
- Approximately 6 months
Secondary outcomes (16)
- measure
- Area under the Plasma Concentration versus Time Curve (AUC)
- timeFrame
- Approximately 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participants with histologically or cytologically confirmed unresectable advanced or recurrent solid tumors. 2. Participants who are refractory or intolerant to standard therapy. 3. Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1. 4. Participants with tumor tissue samples available for biomarker testing. Exclusion Criteria: 1. Participants with a history or presence of severe hypersensitivity to any other antibody agents. 2. Participants with pericardial fluid, pleural effusion or ascites requiring treatment 3. Participants with uncontrolled tumor-related pain 4. Participants with severe peritoneal dissemination. 5. Participants with multiple primary cancers. 6. Participants with a history or presence of ILD or pulmonary fibrosis.
References
Publications (0)
Data not yet available
No reference posted for this study.