ONO-7914-01:Phase I study of ONO-7914 alone and in combination with ONO-4538 in patients with solid tumors

JRCT ID: jRCT2031210530

Registered date:28/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: advanced or metastatic solid tumors
• Date of first enrollment: 08/02/2022
• Target sample size: 204
• Study type: Interventional
• Intervention(s): ONO-7914 is administered as a single agent or combination with ONO-4538.

Outcome(s)

• Primary Outcome: Safety and tolerability
• Secondary Outcome: Pharmacokinetics for ONO-7914 and ONO-4538

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

1.Patients with advanced or metastatic solid tumor
2.Patients with ECOG performance status of 0 or 1
3.Patients with a life expectancy of at least 3 months

Exclude criteria

1.Patients with severe complication
2.Patients judged to be incapable of providing consent for reasons such as concurrent dementia

Related Information

• Primary Sponsor: Hirashima Yoshinori