Clinical trial NCT06540261: The Study of ONO-7913, ONO-4538 and the Standard of Care as First-line Treatment in Patients Colorectal Cancer
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Unresectable Colorectal Cancer
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-06
Enrollment: 65
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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 outcomes:
measure: Dose-limiting toxicities（DLT）
timeFrame: 28 days
measure: Adverse event (AE)
timeFrame: Up to 30 days after the last dose
Secondary outcomes:
measure: Pharmacokinetics（Plasma concentration of ONO-7913）
timeFrame: Through study completion, an average of 1 year.
measure: Pharmacokinetics（Plasma concentration of ONO-4538）
timeFrame: Through study completion, an average of 1 year.
measure: Objective Response Rate (ORR)
timeFrame: Through study completion, an average of 1 year.
measure: Disease Control Rate (DCR)
timeFrame: Through study completion, an average of 1 year.
measure: Overall Survival (OS)
timeFrame: Through study completion, an average of 3 years.
measure: Progression-Free Survival (PFS)
timeFrame: Through study completion, an average of 1 years.
measure: Duration of Response (DOR)
timeFrame: Through study completion, an average of 1 years.
measure: Time to Response (TTR)
timeFrame: Through study completion, an average of 1 years.
measure: Best Overall Response (BOR)
timeFrame: Through study completion, an average of 1 years.
measure: Percent change in the sum diameters of the target lesions
timeFrame: Through study completion, an average of 1 years.
measure: Maximum percent change in the sum diameters of the target lesions
timeFrame: Through study completion, an average of 1 years.
measure: Early Tumor shrinkage（ETS）
timeFrame: Up to 8 weeks
measure: Change From Baseline in Tumour Biomarkers (CEA and CA19-9)
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital
state: Hyogo
city: Kawasaki
country: Japan
facility: St. Marianna University Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Ina
country: Japan
facility: Saitama Cancer Center
state: Saitama
city: Koto-Ku
country: Japan
facility: Cancer Institute Hospital of JFCR
state: Tokyo
city: Chuo Ku
country: Japan
facility: National Cancer Center Hospital
state: Toyko
city: Chiba
country: Japan
facility: Chiba Cancer Center
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
Study officials:
References: