Advanced or Metastatic Solid TumorsPhase 1NCT03730337
Phase 1 Study of ONO-7475 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
A Phase 1 study testing ONO-7475 and ONO-7475 + ONO-4538 in people with Advanced or Metastatic Solid Tumors, run by Ono Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To evaluate the tolerability and safety of ONO-7475 monotherapy and combinations with ONO-4538 in patients with advanced or metastatic solid tumors Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- ONO-7475 and ONO-7475 + ONO-4538
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteJapan
- Study dates
- 17 Oct 2018to 22 Nov 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 0～1
- Patients with life expectancy of at least 3 months
Who cannot join
- Patients with history of severe allergy
- Patients with multiple cancers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
To evaluate the tolerability and safety of ONO-7475 monotherapy and combinations with ONO-4538 in patients with advanced or metastatic solid tumors
- Conditions
- Advanced or Metastatic Solid Tumors
- Being tested
- ONO-7475, ONO-7475 + ONO-4538
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-7475Drug
ONO-7475 specified dose on specified days
ONO-7475 + ONO-4538Drug
ONO-7475+ONO-4538 specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| ONO-7475 monotherapy | Experimental | Not described Receives: Drug: ONO-7475 |
| ONO-7475 in combination with ONO-4538 | Experimental | Not described Receives: Drug: ONO-7475 + ONO-4538 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of paticipants with dose-limiting toxicities during the DLT evaluation period
Measured: 28 days
Incidence and severity of adverse events as assessed by CTCAE v4.0 to determine the tolerability and safety
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Pharmacokinetics (Cmax)
Assessment of the maximum plasma concentration of ONO-7475 both alone and in combination with ONO-4538
Measured: Through study completion
Pharmacokinetics (Tmax)
Assessment of the time to reach maximum observed plasma concentration of ONO-7475 both alone and in combination with ONO-4538
Measured: Through study completion
Pharmacokinetics (AUC)
Assessment of the plasma area under the curve of ONO-7475 both alone and in combination with ONO-4538
Measured: Through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start17 Oct 2018
- Primary completion28 Jun 2021
- Study completion22 Nov 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 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
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
- NCT03730337
- Sponsor's protocol ID
- ONO-7475-02 / ONO-4538-74
- Status last verified
- Sep 2023
- First submitted
- 30 Oct 2018
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao 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.
PubMed 39779468
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03730337
- Acronym / sponsor ID
- ONO-7475-02 / ONO-4538-74
- Conditions
- Advanced or Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2018 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 22 Nov 2022 (actual)
- First posted
- 5 Nov 2018 (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 evaluate the tolerability and safety of ONO-7475 monotherapy and combinations with ONO-4538 in patients with advanced or metastatic solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONO-7475 monotherapy | Experimental | Drug: ONO-7475 |
| ONO-7475 in combination with ONO-4538 | Experimental | Drug: ONO-7475 + ONO-4538 |
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 0～1
- Patients with life expectancy of at least 3 months
Key exclusion criteria (2 listed)
- Patients with history of severe allergy
- Patients with multiple cancers
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-7475ONO-7475 specified dose on specified days | Drug | ONO-7475 monotherapy |
| ONO-7475 + ONO-4538ONO-7475+ONO-4538 specified dose on specified days | Drug | ONO-7475 in combination with ONO-4538 |
Primary outcome
Number of paticipants with dose-limiting toxicities during the DLT evaluation period
Time frame: 28 days
Incidence and severity of adverse events as assessed by CTCAE v4.0 to determine the tolerability and safety
Time frame: Through study completion, an average of 1 year
3 secondary outcomes
Pharmacokinetics (Cmax)
Time frame: Through study completion
Pharmacokinetics (Tmax)
Time frame: Through study completion
Pharmacokinetics (AUC)
Time frame: Through study completion
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 4 Oct 2023.
- Derived from this study: PubMed 39779468Zhao 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.
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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.
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-7475 and ONO-7475 + ONO-4538 in people with Advanced or Metastatic Solid Tumors, 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 4 Oct 2023. 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?
Number of paticipants with dose-limiting toxicities during the DLT evaluation period (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 NCT03730337, 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 4 Oct 2023.