Advanced or Metastatic Solid TumorsPhase 1NCT03155061
Study of ONO-4578 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
A Phase 1 study testing ONO-4578 and ONO-4538 in people with Advanced or Metastatic Solid Tumors, run by Ono Pharmaceutical Co., Ltd. at 22 sites in Japan.
Trial summary
The objective of the study is to evaluate the safety, tolerability, pharmacokinetics, efficacy and biomarker of ONO-4578 and combinations of ONO-4578 and ONO-4538 in subjects with advanced or metastatic solid tumors and subjects with unresectable, advanced or recurrent gastric cancer, unresectable, advanced or… 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-4578 and ONO-4538
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 22 sitesJapan
- Study dates
- 19 Apr 2017to Mar 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced or metastatic solid tumors (Part A, B)
- Unresectable, advanced or recurrent gastric cancer previously treated with anti-PD-(L)1 antibodies or naive to anti-PD-(L)1 antibodies (Part C)
- Unresectable, advanced or recurrent colorectal cancer(Part D)
- Life expectancy of at least 3 months
- Patients with ECOG performance status 0 or 1
Who cannot join
- Patients with severe complication
- Patients with multiple primary cancers
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Japan22 sites
Tokyo Clinical Site 1
Chuo-ku, Tokyo
Fukuoka Clinical Site 1
Fukuoka, Fukuoka
Fukuoka Clinical Site 2
Fukuoka, Fukuoka
Saitama Clinical Site 2
Hidaka, Saitama
Osaka Clinical Site 2
Hirakata, Osaka
Saitama Clinical Site 1
Ina-machi, Saitama
Chiba Clinical Site 1
Kashiwa, Chiba
Tokyo Clinical Site 2
Koto-ku, Tokyo
Ehime Clinical Site1
Matsuyama, Ehime
Shizuoka Clinical Site 1
Nagaizumi-Cho, Shizuoka
Aichi Clinical Site 1
Nagoya, Aichi-ken
Osaka Clinical Site 1
Osaka, Osaka
Gunma Clinical Site 1
Ōta, Gunma
Kanagawa Clinical Site 2
Sagamihara, Kanagawa
Osaka Clinical Site 3
Sakai, Osaka
Hokkaido Clinical Site 1
Sapporo, Hokkaido
Tokyo Clinical Site 3
Shinjyuku-ku, Tokyo
Tokyo Clinical Site 4
tabashi City, Tokyo
Osaka Clinical Site 4
Takatsuki, Osaka
Aichi Clinical Site 2
Toyoake, Aichi-ken
Iwate Clinical Site 1
Yahaba-cho, Iwate
Kanagawa Clinical Site 1
Yokohama, Kanagawa
About this study
Official title: Phase 1 Dose Escalating and Expansion Study of ONO-4578 Given as Monotherapy and Combinations of ONO-4578 and ONO-4538 in Subjects With Advanced or Metastatic Solid Tumors
The objective of the study is to evaluate the safety, tolerability, pharmacokinetics, efficacy and biomarker of ONO-4578 and combinations of ONO-4578 and ONO-4538 in subjects with advanced or metastatic solid tumors and subjects with unresectable, advanced or recurrent gastric cancer, unresectable, advanced or recurrent colorectal cancer.
- Conditions
- Advanced or Metastatic Solid Tumors
- Being tested
- ONO-4578, ONO-4538
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4578Drug
ONO-4578 specified dose on specified days
ONO-4538Drug
ONO-4538 specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A (Dose Escalation Part): ONO-4578 monotherapy | Experimental | ONO-4578 specified dose on specified days in advanced or metastatic solid tumors Receives: Drug: ONO-4578 |
| Part B: ONO-4578 in combination with ONO-4538 | Experimental | ONO-4578+ONO-4538 specified dose on specified days in advanced or metastatic solid tumors Receives: Drug: ONO-4578; Drug: ONO-4538 |
| Part C (Expansion Part): ONO-4578 in combination with ONO-4538 | Experimental | ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent gastric cancer Receives: Drug: ONO-4578; Drug: ONO-4538 |
| Part D (Expansion Part): ONO-4578 in combination with ONO-4538 | Experimental | ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent colorectal cancer Receives: Drug: ONO-4578; Drug: ONO-4538 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status)
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Maximum observed serum concentration(Cmax)
Measured: Up to Cycle 1 (each cycle is 28 days)
Area Under the blood concentration-time Curve(AUC)
Measured: Up to Cycle 1 (each cycle is 28 days)
Half-life(T1/2) of ONO-4578 both alone and in combination with ONO-4538
Measured: Up to Cycle 1 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start19 Apr 2017
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Sequential
- Masking
- None (open label)
- Enrolment
- 183 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
- NCT03155061
- Sponsor's protocol ID
- ONO-4578-01
- Other IDs
- jRCT2080223441
- Status last verified
- Sep 2026
- First submitted
- 17 Mar 2017
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kawazoe A, Yamaguchi K, Hamaguchi T, Narita Y, Boku S, Oshima T, Hara H, Hamamoto Y, Ishido K, Esaki T, Hosaka H, Yasui H, Koeda K, Nishina T, Tsuji Y, Fukagawa T, Goto M, Oki E, Sugimoto N, Matsuoka H, Yokoyama F, Yoshida T, Yoshida K, Oshima Y, Iwasa S. ONO-4578 Plus Nivolumab in Unresectable Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer. Cancer Sci. 2025 Sep;116(9):2523-2536. doi: 10.1111/cas.70130. Epub 2025 Jul 6.
PubMed 40618725Iwasa S, Koyama T, Nishino M, Kondo S, Sudo K, Yonemori K, Yoshida T, Tamura K, Shimizu T, Fujiwara Y, Kitano S, Shimomura A, Sato J, Yokoyama F, Iida H, Kondo M, Yamamoto N. First-in-human study of ONO-4578, an antagonist of prostaglandin E2 receptor 4, alone and with nivolumab in solid tumors. Cancer Sci. 2023 Jan;114(1):211-220. doi: 10.1111/cas.15574. Epub 2022 Nov 4.
PubMed 36082616
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Dose Escalating and Expansion Study of ONO-4578 Given as Monotherapy and Combinations of ONO-4578 and ONO-4538 in Subjects With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT03155061
- Acronym / sponsor ID
- ONO-4578-01
- Conditions
- Advanced or Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 16 May 2017 (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.
The objective of the study is to evaluate the safety, tolerability, pharmacokinetics, efficacy and biomarker of ONO-4578 and combinations of ONO-4578 and ONO-4538 in subjects with advanced or metastatic solid tumors and subjects with unresectable, advanced or recurrent gastric cancer, unresectable, advanced or recurrent colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A (Dose Escalation Part): ONO-4578 monotherapy | Experimental | Drug: ONO-4578ONO-4578 specified dose on specified days in advanced or metastatic solid tumors |
| Part B: ONO-4578 in combination with ONO-4538 | Experimental | Drug: ONO-4578, Drug: ONO-4538ONO-4578+ONO-4538 specified dose on specified days in advanced or metastatic solid tumors |
| Part C (Expansion Part): ONO-4578 in combination with ONO-4538 | Experimental | Drug: ONO-4578, Drug: ONO-4538ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent gastric cancer |
| Part D (Expansion Part): ONO-4578 in combination with ONO-4538 | Experimental | Drug: ONO-4578, Drug: ONO-4538ONO-4578+ONO-4538 specified dose on specified days in unresectable, advanced or recurrent colorectal cancer |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Advanced or metastatic solid tumors (Part A, B)
- Unresectable, advanced or recurrent gastric cancer previously treated with anti-PD-(L)1 antibodies or naive to anti-PD-(L)1 antibodies (Part C)
- Unresectable, advanced or recurrent colorectal cancer(Part D)
- Life expectancy of at least 3 months
- Patients with ECOG performance status 0 or 1
Key exclusion criteria (2 listed)
- Patients with severe complication
- Patients with multiple primary 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-4578ONO-4578 specified dose on specified days | Drug | Part A (Dose Escalation Part): ONO-4578 monotherapy, Part B: ONO-4578 in combination with ONO-4538, Part C (Expansion Part): ONO-4578 in combination with ONO-4538, Part D (Expansion Part): ONO-4578 in combination with ONO-4538 |
| ONO-4538ONO-4538 specified dose on specified days | Drug | Part B: ONO-4578 in combination with ONO-4538, Part C (Expansion Part): ONO-4578 in combination with ONO-4538, Part D (Expansion Part): ONO-4578 in combination with ONO-4538 |
Primary outcome
Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status)
Time frame: Through study completion, an average of 1 year
3 secondary outcomes
Maximum observed serum concentration(Cmax)
Time frame: Up to Cycle 1 (each cycle is 28 days)
Area Under the blood concentration-time Curve(AUC)
Time frame: Up to Cycle 1 (each cycle is 28 days)
Half-life(T1/2) of ONO-4578 both alone and in combination with ONO-4538
Time frame: Up to Cycle 1 (each cycle is 28 days)
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 4 Sep 2026.
- Derived from this study: PubMed 40618725Kawazoe A, Yamaguchi K, Hamaguchi T, Narita Y, Boku S, Oshima T, Hara H, Hamamoto Y, Ishido K, Esaki T, Hosaka H, Yasui H, Koeda K, Nishina T, Tsuji Y, Fukagawa T, Goto M, Oki E, Sugimoto N, Matsuoka H, Yokoyama F, Yoshida T, Yoshida K, Oshima Y, Iwasa S. ONO-4578 Plus Nivolumab in Unresectable Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer. Cancer Sci. 2025 Sep;116(9):2523-2536. doi: 10.1111/cas.70130. Epub 2025 Jul 6.
- Derived from this study: PubMed 36082616Iwasa S, Koyama T, Nishino M, Kondo S, Sudo K, Yonemori K, Yoshida T, Tamura K, Shimizu T, Fujiwara Y, Kitano S, Shimomura A, Sato J, Yokoyama F, Iida H, Kondo M, Yamamoto N. First-in-human study of ONO-4578, an antagonist of prostaglandin E2 receptor 4, alone and with nivolumab in solid tumors. Cancer Sci. 2023 Jan;114(1):211-220. doi: 10.1111/cas.15574. Epub 2022 Nov 4.
- 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.
22 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-4578 and ONO-4538 in people with Advanced or Metastatic Solid Tumors, run by Ono Pharmaceutical Co., Ltd. at 22 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 5 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 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status) (time frame: Through study completion, an average of 1 year). 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 NCT03155061, which also lists 2 linked publications.
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 Sep 2026.