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

Ono Pharmaceuticals

Status and phase: Active, not recruiting; Phase 1

Conditions: Unresectable Colorectal Cancer

Treatments: Drug: Cetuximab; Drug: Fluorouracil; Drug: ONO-7913; Drug: Oxaliplatin; Drug: Bevacizumab; Drug: Levofolinate; Drug: ONO-4538

Study type: Interventional

Funder types: Industry

Identifiers

NCT06540261

ONO-7913-04

Details and patient eligibility

About

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

Enrollment: 65 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups

ONO-7913＋ONO-4538＋FOLFOX＋Bev

Experimental group

Treatment:

Drug: ONO-4538

Drug: Bevacizumab

Drug: Levofolinate

Drug: Oxaliplatin

Drug: Fluorouracil

Drug: ONO-7913

ONO-7913＋ONO-4538＋FOLFOX＋Cet

Experimental group

Treatment:

Drug: ONO-4538

Drug: Levofolinate

Drug: Oxaliplatin

Drug: Cetuximab

Drug: Fluorouracil

Drug: ONO-7913