Phase 1 Study of ONO-7475 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors

October 2, 2023 updated by: Ono Pharmaceutical Co. Ltd

Open-label, Uncontrolled, Dose-escalation Study of ONO-7475 Given as Monotherapy and Combinations With ONO-4538 in Patients With Advanced or Metastatic Solid Tumors

To evaluate the tolerability and safety of ONO-7475 monotherapy and combinations with ONO-4538 in patients with advanced or metastatic solid tumors

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Tokyo Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with histologically or cytologically confirmed advanced or metastatic solid tumors
  • ECOG Performance Status 0～1
  • Patients with life expectancy of at least 3 months

Exclusion Criteria:

  • Patients with history of severe allergy
  • Patients with multiple cancers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ONO-7475 monotherapy
Drug: ONO-7475
ONO-7475 specified dose on specified days
Experimental: ONO-7475 in combination with ONO-4538
Drug: ONO-7475 + ONO-4538
ONO-7475+ONO-4538 specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of paticipants with dose-limiting toxicities during the DLT evaluation period
Time Frame: 28 days
28 days
Incidence and severity of adverse events as assessed by CTCAE v4.0 to determine the tolerability and safety
Time Frame: Through study completion, an average of 1 year
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (Cmax)
Time Frame: Through study completion
Assessment of the maximum plasma concentration of ONO-7475 both alone and in combination with ONO-4538
Through study completion
Pharmacokinetics (Tmax)
Time Frame: Through study completion
Assessment of the time to reach maximum observed plasma concentration of ONO-7475 both alone and in combination with ONO-4538
Through study completion
Pharmacokinetics (AUC)
Time Frame: Through study completion
Assessment of the plasma area under the curve of ONO-7475 both alone and in combination with ONO-4538
Through study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharmaceutical Co. Ltd

Investigators

  • Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 17, 2018

Primary Completion (Actual)

June 28, 2021

Study Completion (Actual)

November 22, 2022

Study Registration Dates

First Submitted

October 30, 2018

First Submitted That Met QC Criteria

November 2, 2018

First Posted (Actual)

November 5, 2018

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-7475-02 / ONO-4538-74

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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