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

NCT06547385 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-08-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

ONO-4578

Specified dose on specified days

DRUG

ONO-4538

Specified dose on specified days

DRUG

Capecitabine

Specified dose on specified days

DRUG

Oxaliplatin

Specified dose on specified days

DRUG

Fluorouracil

Specified dose on specified days

DRUG

Calcium Levofolinate Hydrateb

Specified dose on specified days

DRUG

Bevacizumab

Specified dose on specified days

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    lead INDUSTRY

Principal Investigators

  • Project Leader · Ono Pharmaceutical Co. Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-13
Primary Completion
2027-10-31
Completion
2027-10-31

Countries

  • Japan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06547385 on ClinicalTrials.gov