Clinical trial · Interventional
ONO-7913 Phase I Study (ONO-7913)
An Open-label, Uncontrolled, Dose Escalation Study in Patients With Advanced or Metastatic Solid Cancers (ONO-7913-01)
NCT04403308CI-TRIAL-00076728completedPhase 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 assess the tolerability, safety, and pharmacokinetics (PK) of ONO-7913 in patients with advanced or metastatic solid cancers and explore its efficacy and biomarkers.
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 |
|---|---|---|---|
| ONO-7913 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ONO-7913 as a Single Agent
- interventionNames
- Biological: ONO-7913
Primary outcomes (2)
- measure
- Dose-limiting toxicities
- timeFrame
- 28 days
- description
- Number of participants with a DLT
- measure
- Adverse events
- timeFrame
- Up to 24 months
- description
- Assessed by the NCI CTCAE v5.0 criteria
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histologically or cytologically confirmed advanced or metastatic solid tumors 2. ECOG Performance Status of 0-1 3. Patients with life expectancy of at least 3 months Exclusion Criteria: 1. Patients with multiple cancers 2. Patients with history of serious allergy
References
Publications (1)
- DERIVEDKoyama T, Shimizu T, Kondo S, Katsuya Y, Sudo K, Yoshida T, Yonemori K, Matsumoto K, Yamamoto N. Tolerability and safety of magrolimab (ONO-7913) in Japanese patients with advanced or metastatic solid tumors: a phase 1, open-label, uncontrolled, dose-escalation study. BMC Res Notes. 2026 Mar 26;19(1):203. doi: 10.1186/s13104-026-07787-6. PMID 41888930