Clinical trial NCT06547385: Study of ONO-4578 and XELOX/FOLFOX Plus Bevacizumab in Colorectal Cancer
Official title: ONO-4578 Phase I Study An Open-label, Uncontrolled Study of First-line Combination Therapy of ONO-4578 and ONO-4538 With Standard Therapy XELOX Plus Bevacizumab or FOLFOX Plus Bevacizumab in Patients With Unresectable, Advanced or Recurrent Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Colorectal Cancer
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-09
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: To evaluate the tolerability and safety of combination of ONO-4578 and ONO-4538 and the standard of care XELOX + bevacizumab or the safety of combination of ONO-4578 and ONO-4538 and the standard of care FOLFOX + bevacizumab as first-line therapy in patients with unresectable, advanced, or recurrent colorectal cancer.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients with severe complication
* Patients are unable to swallow oral medications

Primary outcomes:
measure: Incidence and severity of AEs and SAEs
timeFrame: up to 3years
measure: Incidence and severity of clinical laboratory abnormalities
timeFrame: up to 3years
measure: 12-lead electrocardiography (Heart rate)
timeFrame: up to 3years
measure: 12-lead electrocardiography (PR interval)
timeFrame: up to 3years
measure: 12-lead electrocardiography (RR interval)
timeFrame: up to 3years
measure: 12-lead electrocardiography (QRS width)
timeFrame: up to 3years
measure: 12-lead electrocardiography (QT interval)
timeFrame: up to 3years
measure: Chest X-ray test
timeFrame: up to 3years
measure: ECOG performance status
timeFrame: up to 3years
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: up to 3years
measure: Disease control rate (DCR)
timeFrame: up to 3years
measure: Overall survival (OS)
timeFrame: up to 3years
measure: Progression-free survival (PFS)
timeFrame: up to 3years
measure: Duration of response (DOR)
timeFrame: up to 3years
measure: Time to response (TTR)
timeFrame: up to 3years
measure: Best oveall response (BOR)
timeFrame: up to 3years
measure: Percentage of change in the sum of tumor diameters of target lesions
timeFrame: up to 3years
measure: Maximum percent change in the sum diameters of the target lesions
timeFrame: up to 3years
measure: Time course of tumor markers
timeFrame: up to 3years
measure: Plasma ONO-4578 concentration
timeFrame: up to 3years
measure: Serum ONO-4538 concentration
timeFrame: up to 3years
measure: Anti-ONO-4538 antibody
timeFrame: up to 3years
Other outcomes:
Locations:
city: Kashiwa-shi
country: Japan
facility: National Cancer Center Hospital East
state: Chiba
city: Kobe-shi
country: Japan
facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital
state: Hyogo
city: Yokohama-shi
country: Japan
facility: Kanagawa Cancer Center
state: Kanagawa
city: Ina
country: Japan
facility: Saitama Cancer Center
state: Kitaadati-gun, Saitama
city: Osaka-shi
country: Japan
facility: NHO Osaka National Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka General Medical Center
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital
state: Osaka
city: Hidaka-shi
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Koto-Ku
country: Japan
facility: Cancer Institute Hospital of JFCR
state: Tokyo
Study officials:
affiliation: Ono Pharmaceutical Co. Ltd
name: Project Leader
role: STUDY_DIRECTOR
References: