Clinical trial · Interventional
A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
An Open-label, Uncontrolled, Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
- 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 is a multicenter, open-label, uncontrolled, phase I study to evaluate the tolerability, safety, pharmacokinetics, and efficacy of ONO-4538HSC administered subcutaneously in participants with advanced or metastatic solid tumors. This study consists of the tolerability confirmation part to determine the recommended dose for Japanese participants by evaluating the DLTs and the expansion part to evaluate the safety and pharmacokinetics and to explore the efficacy.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ONO-4538HSC | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ONO-4538HSC
- interventionNames
- Drug: ONO-4538HSC
Primary outcomes (2)
- measure
- Dose-limiting toxicities (DLT)
- timeFrame
- 28 days
- measure
- Adverse event (AE)
- timeFrame
- UP to 100 days after the last dose
Secondary outcomes (1)
- measure
- Pharmacokinetics（serum concentration of Nivolumab）
- timeFrame
- Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient with advanced or metastatic solid tumors 2. Patients have an ECOG performance status of 0 to 1 3. Patients with a life expectancy of at least 3 months \[Tolerability confirmation part\] 4. Patients who are refractory or intolerant to standard therapy or for whom no standard therapy is available \[Expansion part\] 5. Patients who are refractory or intolerant to standard therapy, or for whom no standard therapy is available, or for whom monotherapy with intravenous nivolumab is indicated according to the package insert Exclusion Criteria: 1. Patients with a complication or history of severe hypersensitivity to any antibody product 2. Patients with severe complication
References
Publications (0)
Data not yet available