ONO-7913-04: ONO-7913 Phase 1 Study

JRCT ID: jRCT2051210038

Registered date:15/06/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Unresectable advanced or recurrent colorectal cancer
• Date of first enrollment: 23/09/2021
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Administration of ONO-7913 and ONO-4538 with FOLFOX and Bevacizumab or Cetuximab

Outcome(s)

• Primary Outcome: Tolerability, safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

1. Patients with severe complication
2. Patients with multiple primary cancers

Related Information

• Primary Sponsor: Hirashima Yoshinori