Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06540261

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Unresectable Colorectal Cancer

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fujita Health University Hospital, Toyoake, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unresectable advanced or recurrent colorectal cancer
  • Life expectancy of at least 3 months
  • Patients with ECOG performance status 0 or 1

Exclusion criteria

  • Patients with severe complication
  • Patients with multiple primary cancers

Treatment and study plan

ONO-7913

Drug

Specified dose on specified days

Other names: Magrolimab

ONO-4538

Drug

Specified dose on specified days

Other names: Nivolumab

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

Primary outcomes

  1. Dose-limiting toxicities（DLT）

    Time frame: 28 days

  2. Adverse event (AE)

    Time frame: Up to 30 days after the last dose

Secondary outcomes

  1. Pharmacokinetics（Plasma concentration of ONO-7913）

    Time frame: Through study completion, an average of 1 year.

  2. Pharmacokinetics（Plasma concentration of ONO-4538）

    Time frame: Through study completion, an average of 1 year.

  3. Objective Response Rate (ORR)

    Time frame: Through study completion, an average of 1 year.

  4. Disease Control Rate (DCR)

    Time frame: Through study completion, an average of 1 year.

  5. Overall Survival (OS)

    Time frame: Through study completion, an average of 3 years.

  6. Progression-Free Survival (PFS)

    Time frame: Through study completion, an average of 1 years.

  7. Duration of Response (DOR)

    Time frame: Through study completion, an average of 1 years.

  8. Time to Response (TTR)

    Time frame: Through study completion, an average of 1 years.

  9. Best Overall Response (BOR)

    Time frame: Through study completion, an average of 1 years.

  10. Percent change in the sum diameters of the target lesions

    Time frame: Through study completion, an average of 1 years.

  11. Maximum percent change in the sum diameters of the target lesions

    Time frame: Through study completion, an average of 1 years.

  12. Early Tumor shrinkage（ETS）

    Time frame: Up to 8 weeks

  13. Change From Baseline in Tumour Biomarkers (CEA and CA19-9)

    Time frame: Through study completion, an average of 1 year.

Sponsors and collaborators

Lead sponsor

Ono Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

An Open-label, Uncontrolled Study 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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Aug 6, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.