An Open-label, Uncontrolled Study of ONO-4578 and ONO-4538 in Combination With Standard-of-care Modified FOLFIRINOX (mFFX) or Gemcitabine Plus Nab-paclitaxel (GnP) Therapy as First-line Treatment in Patients With Metastatic Pancreatic Cancer

Ono Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Metastatic Pancreatic Cancer

Treatments: Drug: Irinotecan; Drug: Oxaliplatin; Drug: ONO-4538; Drug: Levofolinate; Drug: Nab-Paclitaxel; Drug: Fluorouracil; Drug: Gemcitabine; Drug: ONO-4578

Study type: Interventional

Funder types: Industry

Identifiers

NCT06538207

ONO-4578-04

jRCT2031200286 (Registry Identifier)

Details and patient eligibility

About

This study is a multicenter, open-label, uncontrolled study to investigate the tolerability and safety of ONO-4578, ONO-4538, and standard of care in combination as first-line treatment in patients with metastatic pancreatic cancer.

Enrollment: 46 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Pancreatic invasive ducatal adenocarcinoma
• 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: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

ONO-4578+ONO-4538+mFFX

Experimental group

Treatment:

Drug: ONO-4578

Drug: Fluorouracil

Drug: Levofolinate

Drug: ONO-4538

Drug: Oxaliplatin

Drug: Irinotecan

ONO-4578+ONO-4538+GnP

Experimental group

Treatment:

Drug: Gemcitabine

Drug: ONO-4578

Drug: Nab-Paclitaxel

Drug: ONO-4538