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Colorectal CancerPhase 1NCT06547385

Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer

A Phase 1 study testing ONO-4578, ONO-4538 and Capecitabine in people with Colorectal Cancer, run by Ono Pharmaceutical Co., Ltd. at 9 sites in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To evaluate the tolerability and safety of combination of ONO-4578 and ONO-4538 and the standard of care XELOX + bevacizumab or the safety of combination of ONO-4578 and ONO-4538 and the standard of care FOLFOX + bevacizumab as first-line therapy 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
Colorectal Cancer
What is being tested?
ONO-4578, ONO-4538 and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
9 sitesJapan
Study dates
13 Jan 2021to 31 Oct 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 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 are unable to swallow oral medications

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Japan9 sites

  • Saitama Medical University International Medical Center

    Hidaka-shi, Saitama

  • Saitama Cancer Center

    Ina, Kitaadati-gun, Saitama

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba

  • Kobe City Hospital Organization Kobe City Medical Center General Hospital

    Kobe, Hyōgo

  • Cancer Institute Hospital of JFCR

    Koto-Ku, Tokyo

  • NHO Osaka National Hospital

    Osaka, Osaka

  • Osaka General Medical Center

    Osaka, Osaka

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki-shi, Osaka

  • Kanagawa Cancer Center

    Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: ONO-4578 Phase I Study An Open-label, Uncontrolled Study of First-line Combination Therapy of ONO-4578 and ONO-4538 With Standard Therapy XELOX Plus Bevacizumab or FOLFOX Plus Bevacizumab in Patients With Unresectable, Advanced or Recurrent Colorectal Cancer

To evaluate the tolerability and safety of combination of ONO-4578 and ONO-4538 and the standard of care XELOX + bevacizumab or the safety of combination of ONO-4578 and ONO-4538 and the standard of care FOLFOX + bevacizumab as first-line therapy in patients with unresectable, advanced, or recurrent colorectal cancer.

Being tested
ONO-4578, ONO-4538, Capecitabine, Oxaliplatin, Fluorouracil
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ONO-4578Drug

    Specified dose on specified days

  • ONO-4538Drug

    Also called Nivolumab

    Specified dose on specified days

  • CapecitabineDrug

    Also called XELODA

    Specified dose on specified days

  • OxaliplatinDrug

    Also called ELPLAT

    Specified dose on specified days

  • FluorouracilDrug

    Also called 5-FU

    Specified dose on specified days

  • Calcium Levofolinate HydratebDrug

    Also called ISOVORIN

    Specified dose on specified days

  • BevacizumabDrug

    Also called AVASTIN

    Specified dose on specified days

Study groups in NCT06547385
Study groupRoleWhat they receive
ONO-4578+ONO-4538+XELOX plus bevacizumabExperimentalNot described
Receives: Drug: ONO-4578; Drug: ONO-4538; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Bevacizumab
ONO-4578+ONO-4538+FOLFOX plus bevacizumabExperimentalNot described
Receives: Drug: ONO-4578; Drug: ONO-4538; Drug: Oxaliplatin; Drug: Fluorouracil; Drug: Calcium Levofolinate Hydrateb; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of AEs and SAEs

    Measured: up to 3years

  2. Incidence and severity of clinical laboratory abnormalities

    Measured: up to 3years

  3. 12-lead electrocardiography (Heart rate)

    Measured: up to 3years

  4. 12-lead electrocardiography (PR interval)

    Measured: up to 3years

  5. 12-lead electrocardiography (RR interval)

    Measured: up to 3years

  6. 12-lead electrocardiography (QRS width)

    Measured: up to 3years

  7. 12-lead electrocardiography (QT interval)

    Measured: up to 3years

  8. Chest X-ray test

    Measured: up to 3years

  9. ECOG performance status

    Measured: up to 3years

Secondary outcomes (13)

  1. Objective response rate (ORR)

    Measured: up to 3years

  2. Disease control rate (DCR)

    Measured: up to 3years

  3. Overall survival (OS)

    Measured: up to 3years

  4. Progression-free survival (PFS)

    Measured: up to 3years

  5. Duration of response (DOR)

    Measured: up to 3years

  6. Time to response (TTR)

    Measured: up to 3years

  7. Best oveall response (BOR)

    Measured: up to 3years

  8. Percentage of change in the sum of tumor diameters of target lesions

    Measured: up to 3years

  9. Maximum percent change in the sum diameters of the target lesions

    Measured: up to 3years

  10. Time course of tumor markers

    Measured: up to 3years

  11. Plasma ONO-4578 concentration

    Measured: up to 3years

  12. Serum ONO-4538 concentration

    Measured: up to 3years

  13. Anti-ONO-4538 antibody

    Measured: up to 3years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2024
  2. Study start13 Jan 2021
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion31 Oct 2027 (estimated)

Resources

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06547385
Sponsor's protocol ID
ONO-4578-02
Other IDs
jRCT2031200215
Status last verified
Oct 2026
First submitted
1 Aug 2024
Last updated
22 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ONO-4578, ONO-4538 and Capecitabine in people with Colorectal 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 22 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?

Incidence and severity of AEs and SAEs (time frame: up to 3years). The study lists 9 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 NCT06547385.

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 22 Oct 2026.

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