NCT06540261|Active Not RecruitingPhase 1DMC

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

Ono Pharmaceutical Co. Ltd ClinicalTrials.gov

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1 other identifier

ONO-7913-04

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredAug 2024

StartedSep 2021

CompletionDec 2027

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P75+ for phase_1

Timeline

18mo left

Started Sep 2021

Longer than P75 for phase_1

Geographic Reach

1 country

17 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.3 years study duration

Study Progress75%

Sep 2021Dec 2027

Study Start

First participant enrolled

September 23, 2021

Completed

2.9 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2024

Completed

5 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed

3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

6.3 years

First QC Date

August 1, 2024

Last Update Submit

September 9, 2024

Conditions

Unresectable Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (13)

Pharmacokinetics（Plasma concentration of ONO-7913）
Through study completion, an average of 1 year.
Pharmacokinetics（Plasma concentration of ONO-4538）
Through study completion, an average of 1 year.
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.
+8 more secondary outcomes

Study Arms (2)

ONO-7913＋ONO-4538＋FOLFOX＋Bev

EXPERIMENTAL

Drug: ONO-7913Drug: ONO-4538Drug: FluorouracilDrug: OxaliplatinDrug: LevofolinateDrug: Bevacizumab

ONO-7913＋ONO-4538＋FOLFOX＋Cet

EXPERIMENTAL

Drug: ONO-7913Drug: ONO-4538Drug: FluorouracilDrug: OxaliplatinDrug: LevofolinateDrug: Cetuximab