ONO-4578 Phase 1 Study (ONO-4578-01)

ONO-4578-01:Phase 1 dose escalating and expansion study of ONO-4578 given as monotherapy and combinations of ONO-4578 and ONO-4538 in subjects with advanced or metastatic solid tumors

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223441

Enrollment

183

Registered

2017-01-18

Start date

2017-04-19

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

Advanced or metastatic solid tumors (Part A, B) Unresectable, advanced or recurrent gastric cancer (Part C) Unresectable, advanced or recurrent colorectal cancer(Part D)

Interventions

investigational material(s) Generic name etc : ONO-4578 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational materia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Advanced or metastatic solid tumors (Part A, B) 2. Unresectable, advanced or recurrent gastric cancer (Part C) 3. Unresectable, advanced or recurrent colorectal cancer(Part D) 4. Life expectancy of at least 3 months 5. 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 Safety, tolerability	—

Secondary

Measure	Time frame
pharmacokinetics Pharmacokinetics	—

Countries

Japan

Outcome results

None listed

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