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

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT06538207
Phase
PHASE1
Status
Completed

Conditions

  • Metastatic Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ONO-4578 — DRUG
    Specified dose on specified days
  • ONO-4538 — DRUG
    Specified dose on specified days
  • Oxaliplatin — DRUG
    Specified dose on specified days
  • Levofolinate — DRUG
    Specified dose on specified days
  • Irinotecan — DRUG
    Specified dose on specified days
  • Fluorouracil — DRUG
    Specified dose on specified days
  • Gemcitabine — DRUG
    Specified dose on specified days
  • Nab-Paclitaxel — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Jan 13, 2021
Status verified
Feb 2025
Primary completion
Oct 1, 2024
Completion
Jan 30, 2025

Study Design

Enrollment
46 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ONO-4578+ONO-4538+mFFX
  • Experimental: ONO-4578+ONO-4538+GnP

Primary Outcome Measure

Dose-limiting toxicities（DLT） [ Time Frame: 28 days ]

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