Clinical trial · Interventional
Phase 1 Study of ONO-7475 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
Open-label, Uncontrolled, Dose-escalation Study of ONO-7475 Given as Monotherapy and Combinations With ONO-4538 in Patients With Advanced or Metastatic Solid Tumors
NCT03730337CI-TRIAL-00070196completedPhase 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)
To evaluate the tolerability and safety of ONO-7475 monotherapy and combinations 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 |
|---|---|---|---|
| Advanced or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ONO-7475 | Drug | — | UNRESOLVED |
| ONO-7475 + ONO-4538 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ONO-7475 monotherapy
- interventionNames
- Drug: ONO-7475
- type
- EXPERIMENTAL
- label
- ONO-7475 in combination with ONO-4538
- interventionNames
- Drug: ONO-7475 + ONO-4538
Primary outcomes (2)
- measure
- Number of paticipants with dose-limiting toxicities during the DLT evaluation period
- timeFrame
- 28 days
- measure
- Incidence and severity of adverse events as assessed by CTCAE v4.0 to determine the tolerability and safety
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically or cytologically confirmed advanced or metastatic solid tumors * ECOG Performance Status 0～1 * Patients with life expectancy of at least 3 months Exclusion Criteria: * Patients with history of severe allergy * Patients with multiple cancers
References
Publications (1)
- DERIVEDZhao X, Li Y, Yang S, Chen Y, Wu K, Geng J, Liu P, Wang Z, Dai H, Wang C. Orderly Regulation of Macrophages and Fibroblasts by Axl in Bleomycin-Induced Pulmonary Fibrosis in Mice. J Cell Mol Med. 2025 Jan;29(1):e70321. doi: 10.1111/jcmm.70321. PMID 39779468