Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer

Sponsor
Ono Pharmaceutical Co., Ltd.
Study ID
NCT06547385
Phase
PHASE1
Status
Active Not Recruiting

Conditions

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
  • Capecitabine — DRUG
    Specified dose on specified days
  • Oxaliplatin — DRUG
    Specified dose on specified days
  • Fluorouracil — DRUG
    Specified dose on specified days
  • Calcium Levofolinate Hydrateb — DRUG
    Specified dose on specified days
  • Bevacizumab — DRUG
    Specified dose on specified days

Study Details

To evaluate the tolerability and safety of combination of ONO-4578 and ONO-4538 and the standard of care XELOX + bevacizumab or the safety of combination of ONO-4578 and ONO-4538 and the standard of care FOLFOX + bevacizumab as first-line therapy in patients with unresectable, advanced, or recurrent colorectal cancer.

Key Dates

First listed
Aug 9, 2024
Start date
Jan 13, 2021
Status verified
Aug 2024
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
40 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ONO-4578+ONO-4538+XELOX plus bevacizumab
  • Experimental: ONO-4578+ONO-4538+FOLFOX plus bevacizumab

Primary Outcome Measure

Incidence and severity of AEs and SAEs [ Time Frame: up to 3years ]

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