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

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.

City, postcode or hospital

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

Conditions: 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 group	Role	What they receive
ONO-4578+ONO-4538+XELOX plus bevacizumab	Experimental	Not described Receives: Drug: ONO-4578; Drug: ONO-4538; Drug: Capecitabine; Drug: Oxaliplatin; Drug: Bevacizumab
ONO-4578+ONO-4538+FOLFOX plus bevacizumab	Experimental	Not 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.

Incidence and severity of AEs and SAEs
Measured: up to 3years
Incidence and severity of clinical laboratory abnormalities
Measured: up to 3years
12-lead electrocardiography (Heart rate)
Measured: up to 3years
12-lead electrocardiography (PR interval)
Measured: up to 3years
12-lead electrocardiography (RR interval)
Measured: up to 3years
12-lead electrocardiography (QRS width)
Measured: up to 3years
12-lead electrocardiography (QT interval)
Measured: up to 3years
Chest X-ray test
Measured: up to 3years
ECOG performance status
Measured: up to 3years

Secondary outcomes (13)

Objective response rate (ORR)
Measured: up to 3years
Disease control rate (DCR)
Measured: up to 3years
Overall survival (OS)
Measured: up to 3years
Progression-free survival (PFS)
Measured: up to 3years
Duration of response (DOR)
Measured: up to 3years
Time to response (TTR)
Measured: up to 3years
Best oveall response (BOR)
Measured: up to 3years
Percentage of change in the sum of tumor diameters of target lesions
Measured: up to 3years
Maximum percent change in the sum diameters of the target lesions
Measured: up to 3years
Time course of tumor markers
Measured: up to 3years
Plasma ONO-4578 concentration
Measured: up to 3years
Serum ONO-4538 concentration
Measured: up to 3years
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.

13 Jan 202131 Oct 2027

First posted9 Aug 2024
Study start13 Jan 2021
Primary completion31 Oct 2027 (estimated)
Study completion31 Oct 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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