Metastatic Pancreatic CancerPhase 1NCT06532331
A PhaseⅠStudy of ONO-7475 in Combination With ONO-4538 and Gemcitabine Plus Nab-paclitaxel (GnP), the Standard of Care, and ONO-7475 in Combination With GnP in Patients With Pancreatic Cancer
A Phase 1 study testing ONO-7475, ONO-4538 and Nab-paclitaxel in people with Metastatic Pancreatic Cancer, run by Ono Pharmaceutical Co., Ltd. at 9 sites in Japan.
Trial summary
This study is PhaseⅠstudy to examine tolerability and safety of ONO-7475 in combination with ONO-4538 and gemcitabine plus nab-paclitaxel (GnP), the standard of care, and safety of ONO-7475 in combination with GnP in patients with metastatic pancreatic cancer as first-line treatment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- ONO-7475, ONO-4538 and Nab-paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 9 sitesJapan
- Study dates
- 6 Dec 2023to 31 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with metastatic pancreatic cancer
- Patients have an ECOG performance status of 0 to 1
- Patients with a life expectancy of at least 6 months
Who cannot join
- Patients are unable to swallow oral medications
- Patients with severe complication
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Japan9 sites
Juntendo University Hpspital
Bunkyo-ku, Tokyo
The University of Tokyo Hospital
Bunkyo-ku, Tokyo
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka
Kanazawa University Hospital
Kanazawa, Ishikawa-ken
National Cancer Center Hospital East
Kashiwa-shi, Chiba
The Cancer Institute Hospital Of JFCR
Koto-Ku, Tokyo
Aichi Cancer Center
Nagoya, Aichi-ken
Osaka International Cancer Institute
Osaka, Osaka
Kanagawa Cancer Center
Yokohama, Kanagawa
About this study
Official title: A PhaseⅠStudy to Examine Tolerability and Safety of ONO-7475 in Combination With ONO-4538 and Gemcitabine Plus Nab-paclitaxel (GnP), the Standard of Care, and Safety of ONO-7475 in Combination With GnP in Patients With Metastatic Pancreatic Cancer as First-line Treatment
This study is PhaseⅠstudy to examine tolerability and safety of ONO-7475 in combination with ONO-4538 and gemcitabine plus nab-paclitaxel (GnP), the standard of care, and safety of ONO-7475 in combination with GnP in patients with metastatic pancreatic cancer as first-line treatment
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- ONO-7475, ONO-4538, Nab-paclitaxel, Gemcitabine
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-7475Drug
Specified dose on specified days
ONO-4538Drug
Also called Nivolumab
Specified dose on specified days
Nab-paclitaxelDrug
Specified dose on specified days
GemcitabineDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| ONO-7475+GnP | Experimental | Not described Receives: Drug: ONO-7475; Drug: Nab-paclitaxel; Drug: Gemcitabine |
| ONO-7475＋ONO-4538＋GnP | Experimental | Not described Receives: Drug: ONO-7475; Drug: ONO-4538; Drug: Nab-paclitaxel; Drug: Gemcitabine |
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 28 days after the last dose
Secondary outcomes (14)
Pharmacokinetics (Plasma concentration of ONO-7475)
Measured: Up to Cycle16
Pharmacokinetics (Plasma concentration of ONO-4538)
Measured: Through study completion, an average of 6 months
Anti-ONO-4538 antibody
Measured: Through study completion, an average of 6 months
Objective Response Rate (ORR)
Measured: Through study completion, an average of 6 months
Disease Control Rate (DCR)
Measured: Through study completion, an average of 6 months
Overall Survival (OS)
Measured: Through study completion, an average of 1 year
Progression-Free Survival (PFS)
Measured: Through study completion, an average of 6 months
Duration of Response (DOR)
Measured: Through study completion, an average of 6 months
Time to Response (TTR)
Measured: Through study completion, an average of 6 months
Best Overall Response (BOR)
Measured: Through study completion, an average of 6 months
Percent change in the sum diameters of the target lesions
Measured: Through study completion, an average of 6 months
Maximum percent change in the sum diameters of the target lesions
Measured: Through study completion, an average of 6 months
CEA
Measured: Through study completion, an average of 6 months
CA19-9
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start6 Dec 2023
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 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
- NCT06532331
- Sponsor's protocol ID
- ONO-7475-04
- Other IDs
- jRCT2031230429
- Status last verified
- Oct 2026
- First submitted
- 28 Jul 2024
- Last updated
- 6 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 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PhaseⅠStudy to Examine Tolerability and Safety of ONO-7475 in Combination With ONO-4538 and Gemcitabine Plus Nab-paclitaxel (GnP), the Standard of Care, and Safety of ONO-7475 in Combination With GnP in Patients With Metastatic Pancreatic Cancer as First-line Treatment
- ClinicalTrials.gov ID
- NCT06532331
- Acronym / sponsor ID
- ONO-7475-04
- Conditions
- Metastatic Pancreatic Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 1 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 study is PhaseⅠstudy to examine tolerability and safety of ONO-7475 in combination with ONO-4538 and gemcitabine plus nab-paclitaxel (GnP), the standard of care, and safety of ONO-7475 in combination with GnP in patients with metastatic pancreatic cancer as first-line treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONO-7475+GnP | Experimental | Drug: ONO-7475, Drug: Nab-paclitaxel, Drug: Gemcitabine |
| ONO-7475＋ONO-4538＋GnP | Experimental | Drug: ONO-7475, Drug: ONO-4538, Drug: Nab-paclitaxel, Drug: Gemcitabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with metastatic pancreatic cancer
- Patients have an ECOG performance status of 0 to 1
- Patients with a life expectancy of at least 6 months
Key exclusion criteria (2 listed)
- Patients are unable to swallow oral medications
- 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-7475Specified dose on specified days | Drug | ONO-7475+GnP, ONO-7475＋ONO-4538＋GnP |
| ONO-4538Also: NivolumabSpecified dose on specified days | Drug | ONO-7475＋ONO-4538＋GnP |
| Nab-paclitaxelSpecified dose on specified days | Drug | ONO-7475+GnP, ONO-7475＋ONO-4538＋GnP |
| GemcitabineSpecified dose on specified days | Drug | ONO-7475+GnP, ONO-7475＋ONO-4538＋GnP |
Primary outcome
Dose-limiting toxicities (DLT)
Time frame: 28 days
Adverse event (AE)
Time frame: Up to 28 days after the last dose
14 secondary outcomes
Pharmacokinetics (Plasma concentration of ONO-7475)
Time frame: Up to Cycle16
Pharmacokinetics (Plasma concentration of ONO-4538)
Time frame: Through study completion, an average of 6 months
Anti-ONO-4538 antibody
Time frame: Through study completion, an average of 6 months
Objective Response Rate (ORR)
Time frame: Through study completion, an average of 6 months
Disease Control Rate (DCR)
Time frame: Through study completion, an average of 6 months
Overall Survival (OS)
Time frame: Through study completion, an average of 1 year
Progression-Free Survival (PFS)
Time frame: Through study completion, an average of 6 months
Duration of Response (DOR)
Time frame: Through study completion, an average of 6 months
Time to Response (TTR)
Time frame: Through study completion, an average of 6 months
Best Overall Response (BOR)
Time frame: Through study completion, an average of 6 months
Percent change in the sum diameters of the target lesions
Time frame: Through study completion, an average of 6 months
Maximum percent change in the sum diameters of the target lesions
Time frame: Through study completion, an average of 6 months
CEA
Time frame: Through study completion, an average of 6 months
CA19-9
Time frame: Through study completion, an average of 6 months
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 6 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.
9 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-7475, ONO-4538 and Nab-paclitaxel in people with Metastatic Pancreatic Cancer, run by Ono Pharmaceutical Co., Ltd. at 9 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 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: under way, not looking for participants, as of the sponsor's last update on 6 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 9 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 6 Oct 2026.