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Clinical Trials in Japan / NCT06540261
Active, not recruiting Phase 1

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

NCT06540261 · tracked via the Priya Life Science Japan tracker
Sponsor
Ono Pharmaceutical Co., Ltd
Phase
Phase 1
Started
2021-09-23
Last updated
2026-10-07

Condition(s) studied

Unresectable Colorectal Cancer

Investigational drug(s) / intervention(s)

ONO-7913 →ONO-4538 →Fluorouracil →Oxaliplatin →Levofolinate →Bevacizumab →Cetuximab →

ONO-7913: Specified dose on specified days

ONO-4538: Specified dose on specified days

Fluorouracil: Specified dose on specified days

Oxaliplatin: Specified dose on specified days

Levofolinate: Specified dose on specified days

Bevacizumab: Specified dose on specified days

Cetuximab: Specified dose on specified days

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

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Unresectable advanced or recurrent colorectal cancer 2. Life expectancy of at least 3 months 3. Patients with ECOG performance status 0 or 1 Exclusion Criteria: 1. Patients with severe complication 2. Patients with multiple primary cancers

Primary outcome measure(s)

  • Dose-limiting toxicities（DLT） — 28 days
  • Adverse event (AE) — Up to 30 days after the last dose

Trial sites (17)

FacilityCityRegionStatus
Fujita Health University Hospital Toyoake Aichi-ken
Chiba Cancer Center Chiba Chiba
National Cancer Center Hospital East Kashiwa Chiba
Hokkaido University Hospital Sapporo Hokkaido
Kobe City Medical Center General Hospital Kobe Hyōgo
St. Marianna University Hospital Kawasaki Kanagawa
Kanagawa Cancer Center Yokohama Kanagawa
Kurashiki Central Hospital Kurashiki Okayama-ken
Kansai Medical University Hospital Hirakata Osaka
National Hospital Organization Osaka National Hospital Osaka Osaka
Osaka General Medical Center Osaka Osaka
Osaka International Cancer Institute Osaka Osaka
Osaka Medical and Pharmaceutical University Hospital Takatsuki Osaka
Saitama Medical University International Medical Center Hidaka Saitama
Saitama Cancer Center Shinden Saitama
Cancer Institute Hospital of JFCR Koto-Ku Tokyo
National Cancer Center Hospital Chūōku Toyko

On this site

📄 Avastin (bevacizumab) drug profile →

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INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV) Recruiting
Study of DCC-2618 in Patients With GIST After at Least 3 Prior Treatments Recruiting
Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06540261 on ClinicalTrials.gov ↗ ← All trials in Japan