An Open-label, Uncontrolled Study of ONO-7913 and ONO-4538 in Combination With Modified FOLFIRINOX Therapy, the Standard of Care, as First-line Treatment in Patients With Metastatic Pancreatic Cancer

Ono Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Metastatic Pancreatic Cancer

Treatments: Drug: ONO-7913; Drug: Fluorouracil; Drug: Irinotecan; Drug: Levofolinate; Drug: ONO-4538; Drug: Oxaliplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06532344

ONO-7913-03

Details and patient eligibility

About

To investigate the tolerability and safety of ONO-7913 and ONO-4538 used in combination with modified FOLFIRINOX (mFFX therapy), the standard of care, as first-line treatment in patients with metastatic pancreatic cancer.

Enrollment: 32 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Untreated metastatic pancreatic cancer
• 2. Life expectancy of at least 3 months
• 3. Patients with ECOG performance status 0 or 1

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

ONO-7913+ONO-4538+mFFX

Experimental group

Treatment:

Drug: Levofolinate

Drug: Oxaliplatin

Drug: ONO-4538

Drug: Fluorouracil

Drug: Irinotecan

Drug: ONO-7913