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

NCT06540261 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-09-19

No results posted yet for this study

Summary

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

Conditions

  • Unresectable Colorectal Cancer

Interventions

DRUG

ONO-7913

Specified dose on specified days

DRUG

ONO-4538

Specified dose on specified days

DRUG

Fluorouracil

Specified dose on specified days

DRUG

Oxaliplatin

Specified dose on specified days

DRUG

Levofolinate

Specified dose on specified days

DRUG

Bevacizumab

Specified dose on specified days

DRUG

Cetuximab

Specified dose on specified days

Sponsors & Collaborators

  • Ono Pharmaceutical Co. Ltd

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-23
Primary Completion
2027-12-31
Completion
2027-12-31

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 NCT06540261 on ClinicalTrials.gov