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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06540261

Enrollment

65

Registered

2024-08-06

Start date

2021-09-23

Completion date

2027-12-31

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable Colorectal Cancer

Brief 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

Interventions

Specified dose on specified days

Specified dose on specified days

DRUGFluorouracil

Specified dose on specified days

DRUGOxaliplatin

Specified dose on specified days

DRUGLevofolinate

Specified dose on specified days

DRUGBevacizumab

Specified dose on specified days

DRUGCetuximab

Specified dose on specified days

Sponsors

Ono Pharmaceutical Co. Ltd

Lead SponsorINDUSTRY

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Dose-limiting toxicities（DLT）	28 days
Adverse event (AE)	Up to 30 days after the last dose

Secondary

Measure	Time frame
Objective Response Rate (ORR)	Through study completion, an average of 1 year.
Disease Control Rate (DCR)	Through study completion, an average of 1 year.
Overall Survival (OS)	Through study completion, an average of 3 years.
Progression-Free Survival (PFS)	Through study completion, an average of 1 years.
Duration of Response (DOR)	Through study completion, an average of 1 years.
Pharmacokinetics（Plasma concentration of ONO-7913）	Through study completion, an average of 1 year.
Best Overall Response (BOR)	Through study completion, an average of 1 years.
Percent change in the sum diameters of the target lesions	Through study completion, an average of 1 years.
Maximum percent change in the sum diameters of the target lesions	Through study completion, an average of 1 years.
Early Tumor shrinkage（ETS）	Up to 8 weeks
Change From Baseline in Tumour Biomarkers (CEA and CA19-9)	Through study completion, an average of 1 year.
Time to Response (TTR)	Through study completion, an average of 1 years.
Pharmacokinetics（Plasma concentration of ONO-4538）	Through study completion, an average of 1 year.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026