Solid TumorPhase 1NCT04403308
ONO-7913 Phase I Study (ONO-7913)
A Phase 1 study testing ONO-7913 in people with Solid Tumor, run by Ono Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- ONO-7913
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteJapan
- Study dates
- 28 Jul 2020to 13 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically confirmed advanced or metastatic solid tumors
- ECOG Performance Status of 0-1
- Patients with life expectancy of at least 3 months
Who cannot join
- Patients with multiple cancers
- Patients with history of serious allergy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Uncontrolled, Dose Escalation Study in Patients With Advanced or Metastatic Solid Cancers (ONO-7913-01)
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
- Solid Tumor
- Being tested
- ONO-7913
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-7913Biological
ONO-7913 will be administered by intravenous continuous infusion during the designated time.
| Study group | Role | What they receive |
|---|---|---|
| ONO-7913 as a Single Agent | Experimental | Not described Receives: Biological: ONO-7913 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities
Number of participants with a DLT
Measured: 28 days
Adverse events
Assessed by the NCI CTCAE v5.0 criteria
Measured: Up to 24 months
Secondary outcomes (1)
Concentration vs time of ONO-7913 as single dose
PK profile
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start28 Jul 2020
- Primary completion13 Jan 2022
- Study completion13 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kazuhiro Nakabayashi, Study chair, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403308
- Sponsor's protocol ID
- ONO-7913-01
- Status last verified
- May 2024
- First submitted
- 21 May 2020
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koyama 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.
PubMed 41888930
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Uncontrolled, Dose Escalation Study in Patients With Advanced or Metastatic Solid Cancers (ONO-7913-01)
- ClinicalTrials.gov ID
- NCT04403308
- Acronym / sponsor ID
- ONO-7913-01
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2020 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 27 May 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ONO-7913 as a Single Agent | Experimental | Biological: ONO-7913 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with histologically or cytologically confirmed advanced or metastatic solid tumors
- ECOG Performance Status of 0-1
- Patients with life expectancy of at least 3 months
Key exclusion criteria (2 listed)
- Patients with multiple cancers
- Patients with history of serious allergy
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-7913ONO-7913 will be administered by intravenous continuous infusion during the designated time. | Biological | ONO-7913 as a Single Agent |
Primary outcome
Dose-limiting toxicities
Time frame: 28 days
Number of participants with a DLT
Adverse events
Time frame: Up to 24 months
Assessed by the NCI CTCAE v5.0 criteria
1 secondary outcome
Concentration vs time of ONO-7913 as single dose
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 41888930Koyama 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.
- Individual participant dataSharing planned: No
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Solid Tumors
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.
Kazuhiro Nakabayashi study chair
Ono Pharmaceutical Co., Ltd.
1 site 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-7913 in people with Solid Tumor, run by Ono Pharmaceutical Co., Ltd. at 1 site 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 3 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: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (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?
On the ClinicalTrials.gov record for NCT04403308, which also lists 1 linked publication.
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 3 May 2024.