Advanced or Metastatic Solid TumorsPhase 1NCT06548217
A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
A Phase 1 study testing ONO-4538HSC in people with Advanced or Metastatic Solid Tumors, run by Ono Pharmaceutical Co., Ltd. at 8 sites in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- ONO-4538HSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 8 sitesJapan
- Study dates
- 7 May 2024to 29 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with advanced or metastatic solid tumors
- Patients have an ECOG performance status of 0 to 1
- Patients with a life expectancy of at least 3 months
- [Tolerability confirmation part]
- Patients who are refractory or intolerant to standard therapy or for whom no standard therapy is available
- [Expansion part]
- 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
Who cannot join
- Patients with a complication or history of severe hypersensitivity to any antibody product
- Patients with severe complication
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
National Cancer Center Hospital
Chuo-ku, Tokyo
National Cancer Center Hospital East
Kashiwa-shi, Chiba
The Cancer Institute Hospital Of JFCR
Koto-ku, Tokyo
Niigata Cancer Center Hospital
Niigata, Niigata
Osaka International Cancer Institute
Osaka, Osaka
Kindai University Hospital
Osakasayama-shi, Osaka
Tohoku University Hospital
Sendai, Miyagi
Shizuoka Cancer Center
Sunto-gun, Shizuoka
About this study
Official title: An Open-label, Uncontrolled, Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
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
- Advanced or Metastatic Solid Tumors
- Being tested
- ONO-4538HSC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4538HSCDrug
ONO-4538HSC will be administered subcutaneously once every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ONO-4538HSC | Experimental | Not described Receives: Drug: ONO-4538HSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLT)
Measured: 28 days
Adverse event (AE)
Measured: UP to 100 days after the last dose
Secondary outcomes (1)
Pharmacokinetics（serum concentration of Nivolumab）
Measured: Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start7 May 2024
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548217
- Sponsor's protocol ID
- ONO-4538HSC-01
- Other IDs
- jRCT2011230059
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Uncontrolled, Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06548217
- Acronym / sponsor ID
- ONO-4538HSC-01
- Conditions
- Advanced or Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 May 2024 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ONO-4538HSC | Experimental | Drug: ONO-4538HSC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient with advanced or metastatic solid tumors
- Patients have an ECOG performance status of 0 to 1
- Patients with a life expectancy of at least 3 months
- [Tolerability confirmation part]
- Patients who are refractory or intolerant to standard therapy or for whom no standard therapy is available
Key exclusion criteria (2 listed)
- Patients with a complication or history of severe hypersensitivity to any antibody product
- Patients with severe complication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-4538HSCONO-4538HSC will be administered subcutaneously once every 4 weeks. | Drug | ONO-4538HSC |
Primary outcome
Dose-limiting toxicities (DLT)
Time frame: 28 days
Adverse event (AE)
Time frame: UP to 100 days after the last dose
1 secondary outcome
Pharmacokinetics（serum concentration of Nivolumab）
Time frame: Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Project Leader study director
Ono Pharmaceutical Co., Ltd.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ONO-4538HSC in people with Advanced or Metastatic Solid Tumors, run by Ono Pharmaceutical Co., Ltd. at 8 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (DLT) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.