# 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

> **NCT06538207** · PHASE1 · COMPLETED · sponsor: **Ono Pharmaceutical Co., Ltd.** · enrollment: 46 (actual)

## Conditions studied

- Metastatic Pancreatic Cancer

## Interventions

- **DRUG:** ONO-4578
- **DRUG:** ONO-4538
- **DRUG:** Oxaliplatin
- **DRUG:** Levofolinate
- **DRUG:** Irinotecan
- **DRUG:** Fluorouracil
- **DRUG:** Gemcitabine
- **DRUG:** Nab-Paclitaxel

## Key facts

- **NCT ID:** NCT06538207
- **Lead sponsor:** Ono Pharmaceutical Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2021-01-13
- **Primary completion:** 2024-10-01
- **Final completion:** 2025-01-30
- **Target enrollment:** 46 (ACTUAL)
- **Last updated:** 2025-02-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06538207

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06538207, "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". Retrieved via AI Analytics 2026-06-09 from https://api.ai-analytics.org/clinical/NCT06538207. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*