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

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT06532344
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Metastatic Pancreatic Cancer

Eligibility Criteria

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

Interventions

  • ONO-7913 — 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

Study Details

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.

Key Dates

Start date
Jul 30, 2021
Status verified
Nov 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
32 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ONO-7913+ONO-4538+mFFX

Primary Outcome Measure

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

Related Studies