The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT06540261
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Unresectable Colorectal 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
  • Fluorouracil — DRUG
    Specified dose on specified days
  • Oxaliplatin — DRUG
    Specified dose on specified days
  • Levofolinate — DRUG
    Specified dose on specified days
  • Bevacizumab — DRUG
    Specified dose on specified days
  • Cetuximab — DRUG
    Specified dose on specified days

Study Details

To confirm the tolerability and safety of combined administration of ONO-7913, ONO-4538 and the standard of care FOLFOX in combination with bevacizumab or cetuximab as first-line treatment in patients with unresectable advanced or recurrent colorectal cancer

Key Dates

First listed
Aug 6, 2024
Start date
Sep 23, 2021
Status verified
Sep 2024
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
65 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ONO-7913＋ONO-4538＋FOLFOX＋Bev
  • Experimental: ONO-7913＋ONO-4538＋FOLFOX＋Cet

Primary Outcome Measure

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