Unresectable Colorectal CancerPhase 1NCT06540261
The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer
A Phase 1 study testing ONO-7913, ONO-4538 and Fluorouracil in people with Unresectable Colorectal Cancer, run by Ono Pharmaceutical Co., Ltd. at 17 sites in Japan.
Trial summary
To confirm the tolerability and safety of combined administration of ONO-7913, ONO-4538 and the standard of care FOLFOX in combination with bevacizumab or cetuximab as first-line treatment in patients with unresectable advanced or recurrent colorectal cancer Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Unresectable Colorectal Cancer
- What is being tested?
- ONO-7913, ONO-4538 and Fluorouracil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 17 sitesJapan
- Study dates
- 23 Sep 2021to 31 Dec 2027
- 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
- Unresectable advanced or recurrent colorectal cancer
- 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
17 sites in 1 country.
17 sites in 1 country
Japan17 sites
Chiba Cancer Center
Chiba, Chiba
National Cancer Center Hospital
Chūōku, Toyko
Saitama Medical University International Medical Center
Hidaka, Saitama
Kansai Medical University Hospital
Hirakata, Osaka
National Cancer Center Hospital East
Kashiwa, Chiba
St. Marianna University Hospital
Kawasaki, Kanagawa
Kobe City Medical Center General Hospital
Kobe, Hyōgo
Cancer Institute Hospital of JFCR
Koto-Ku, Tokyo
Kurashiki Central Hospital
Kurashiki, Okayama-ken
National Hospital Organization Osaka National Hospital
Osaka, Osaka
Osaka General Medical Center
Osaka, Osaka
Osaka International Cancer Institute
Osaka, Osaka
Hokkaido University Hospital
Sapporo, Hokkaido
Saitama Cancer Center
Shinden, Saitama
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka
Fujita Health University Hospital
Toyoake, Aichi-ken
Kanagawa Cancer Center
Yokohama, Kanagawa
About this study
Official title: An Open-label, Uncontrolled Study of ONO-7913, ONO-4538 and the Standard of Care FOLFOX in Combination With Bevacizumab or Cetuximab as First-line Treatment in Patients With Unresectable Advanced or Recurrent Colorectal Cancer
To confirm the tolerability and safety of combined administration of ONO-7913, ONO-4538 and the standard of care FOLFOX in combination with bevacizumab or cetuximab as first-line treatment in patients with unresectable advanced or recurrent colorectal cancer
- Conditions
- Unresectable Colorectal Cancer
- Being tested
- ONO-7913, ONO-4538, Fluorouracil, Oxaliplatin, Levofolinate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-7913Drug
Also called Magrolimab
Specified dose on specified days
ONO-4538Drug
Also called Nivolumab
Specified dose on specified days
FluorouracilDrug
Specified dose on specified days
OxaliplatinDrug
Specified dose on specified days
LevofolinateDrug
Specified dose on specified days
BevacizumabDrug
Specified dose on specified days
CetuximabDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| ONO-7913＋ONO-4538＋FOLFOX＋Bev | Experimental | Not described Receives: Drug: ONO-7913; Drug: ONO-4538; Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Levofolinate; Drug: Bevacizumab |
| ONO-7913＋ONO-4538＋FOLFOX＋Cet | Experimental | Not described Receives: Drug: ONO-7913; Drug: ONO-4538; Drug: Fluorouracil; Drug: Oxaliplatin; Drug: Levofolinate; Drug: Cetuximab |
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 30 days after the last dose
Secondary outcomes (13)
Pharmacokinetics（Plasma concentration of ONO-7913）
Measured: Through study completion, an average of 1 year.
Pharmacokinetics（Plasma concentration of ONO-4538）
Measured: Through study completion, an average of 1 year.
Objective Response Rate (ORR)
Measured: Through study completion, an average of 1 year.
Disease Control Rate (DCR)
Measured: Through study completion, an average of 1 year.
Overall Survival (OS)
Measured: Through study completion, an average of 3 years.
Progression-Free Survival (PFS)
Measured: Through study completion, an average of 1 years.
Duration of Response (DOR)
Measured: Through study completion, an average of 1 years.
Time to Response (TTR)
Measured: Through study completion, an average of 1 years.
Best Overall Response (BOR)
Measured: Through study completion, an average of 1 years.
Percent change in the sum diameters of the target lesions
Measured: Through study completion, an average of 1 years.
Maximum percent change in the sum diameters of the target lesions
Measured: Through study completion, an average of 1 years.
Early Tumor shrinkage（ETS）
Measured: Up to 8 weeks
Change From Baseline in Tumour Biomarkers (CEA and CA19-9)
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start23 Sep 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Colorectal 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 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
- NCT06540261
- Sponsor's protocol ID
- ONO-7913-04
- Other IDs
- jRCT2051210038
- Status last verified
- Oct 2026
- First submitted
- 1 Aug 2024
- Last updated
- 7 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Uncontrolled Study of ONO-7913, ONO-4538 and the Standard of Care FOLFOX in Combination With Bevacizumab or Cetuximab as First-line Treatment in Patients With Unresectable Advanced or Recurrent Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06540261
- Acronym / sponsor ID
- ONO-7913-04
- Conditions
- Unresectable Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 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.
To confirm the tolerability and safety of combined administration of ONO-7913, ONO-4538 and the standard of care FOLFOX in combination with bevacizumab or cetuximab as first-line treatment in patients with unresectable advanced or recurrent colorectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONO-7913＋ONO-4538＋FOLFOX＋Bev | Experimental | Drug: ONO-7913, Drug: ONO-4538, Drug: Fluorouracil, Drug: Oxaliplatin, Drug: Levofolinate, Drug: Bevacizumab |
| ONO-7913＋ONO-4538＋FOLFOX＋Cet | Experimental | Drug: ONO-7913, Drug: ONO-4538, Drug: Fluorouracil, Drug: Oxaliplatin, Drug: Levofolinate, Drug: Cetuximab |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unresectable advanced or recurrent colorectal cancer
- 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-7913Also: MagrolimabSpecified dose on specified days | Drug | ONO-7913＋ONO-4538＋FOLFOX＋Bev, ONO-7913＋ONO-4538＋FOLFOX＋Cet |
| ONO-4538Also: NivolumabSpecified dose on specified days | Drug | ONO-7913＋ONO-4538＋FOLFOX＋Bev, ONO-7913＋ONO-4538＋FOLFOX＋Cet |
| FluorouracilSpecified dose on specified days | Drug | ONO-7913＋ONO-4538＋FOLFOX＋Bev, ONO-7913＋ONO-4538＋FOLFOX＋Cet |
| OxaliplatinSpecified dose on specified days | Drug | ONO-7913＋ONO-4538＋FOLFOX＋Bev, ONO-7913＋ONO-4538＋FOLFOX＋Cet |
| LevofolinateSpecified dose on specified days | Drug | ONO-7913＋ONO-4538＋FOLFOX＋Bev, ONO-7913＋ONO-4538＋FOLFOX＋Cet |
| BevacizumabSpecified dose on specified days | Drug | ONO-7913＋ONO-4538＋FOLFOX＋Bev |
| CetuximabSpecified dose on specified days | Drug | ONO-7913＋ONO-4538＋FOLFOX＋Cet |
Primary outcome
Dose-limiting toxicities（DLT）
Time frame: 28 days
Adverse event (AE)
Time frame: Up to 30 days after the last dose
13 secondary outcomes
Pharmacokinetics（Plasma concentration of ONO-7913）
Time frame: Through study completion, an average of 1 year.
Pharmacokinetics（Plasma concentration of ONO-4538）
Time frame: Through study completion, an average of 1 year.
Objective Response Rate (ORR)
Time frame: Through study completion, an average of 1 year.
Disease Control Rate (DCR)
Time frame: Through study completion, an average of 1 year.
Overall Survival (OS)
Time frame: Through study completion, an average of 3 years.
Progression-Free Survival (PFS)
Time frame: Through study completion, an average of 1 years.
Duration of Response (DOR)
Time frame: Through study completion, an average of 1 years.
Time to Response (TTR)
Time frame: Through study completion, an average of 1 years.
Best Overall Response (BOR)
Time frame: Through study completion, an average of 1 years.
Percent change in the sum diameters of the target lesions
Time frame: Through study completion, an average of 1 years.
Maximum percent change in the sum diameters of the target lesions
Time frame: Through study completion, an average of 1 years.
Early Tumor shrinkage（ETS）
Time frame: Up to 8 weeks
Change From Baseline in Tumour Biomarkers (CEA and CA19-9)
Time frame: Through study completion, an average of 1 year.
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 7 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.
17 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-7913, ONO-4538 and Fluorouracil in people with Unresectable Colorectal Cancer, run by Ono Pharmaceutical Co., Ltd. at 17 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 7 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 17 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 7 Oct 2026.