ONO-4578-03:ONO-4578 Phase 1 Study

ONO-4578-03:Phase 1 study of ONO-4578 given as monotherapy and combinations of ONO-4578 and ONO-4538 as sequential treatment (neoadjuvant therapy) after chemoradiation therapy in subjects with resectable advanced rectal cancer

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2051200096

Enrollment

Registered

2020-12-15

Start date

2021-01-20

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

Resectable rectal cancer

Interventions

ONO-4578 and combinations of ONO-4578 and ONO-4538 as neoadjuvant therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Rectal adenocarcinoma 2. Patients with ECOG performance status 0 or 1

Exclusion criteria

Exclusion criteria: 1. Patients with severe complication 2. Patients with multiple primary cancers

Design outcomes

Primary

Measure	Time frame
Safety, tolerability	—

Contacts

Public ContactMedical Center

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