ONO-7475-04:A Phase1 study of ONO-7475 in combination with ONO-4538 and gemcitabine plus nab-paclitaxel (GnP), the standard of care, and ONO-7475 in combination with GnP in patients with pancreatic cancer

JRCT ID: jRCT2031230429

Registered date:03/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: metastatic pancreatic cancer
• Date of first enrollment: 06/12/2023
• Target sample size: 87
• Study type: Interventional
• Intervention(s): ONO-7475 in combination with ONO-4538 and gemcitabine plus nab-paclitaxel (GnP), the standard of care, and ONO-7475 in combination with GnP

Outcome(s)

• Primary Outcome: Safety and tolerability
• Secondary Outcome: Efficacy, pharmacokinetics and immunogenicity

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patient with metastatic pancreatic cancer
2.Patients have an ECOG performance status of 0 to 1
3.Patients with a life expectancy of at least 6 months

Exclude criteria

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

Related Information

• Primary Sponsor: Hirashima Yoshinori