ONO-4578-02:ONO-4578 Phase 1 Study

ONO-4578-02: 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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031200215

Enrollment

Registered

2020-11-25

Start date

2021-01-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable colorectal cancer

Interventions

ONO-4578 given as combinations of ONO-4578, ONO-4538, XELOX plus bevacizumab or FOLFOX plus bevacizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Unresectable colorectal cancer 2. Life expectancy of at least 3 months 3. Patients with ECOG performance status 0 or 1

Exclusion criteria

Exclusion criteria: 1. Patients with severe complication 2. Patients are unable to swallow oral medications

Design outcomes

Primary

Measure	Time frame
Safety, tolerability	—

Contacts

Public ContactCenter Medical

Ono Pharmaceutical Co.,LTD

clinical_trial@ono-pharma.com+81-120-626-190

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026