Study of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Solid Tumors

June 1, 2025 updated by: Ono Pharmaceutical Co. Ltd

A Phase I, Open-label, Uncontrolled, Dose Escalation Study to Evaluate the Tolerability and Safety of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Advanced or Metastatic Solid Tumors

This study is dose escalation study to evaluate the tolerability and safety of ONO-7914 alone and in combination with ONO-4538 in patients with advanced or metastatic solid tumors

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

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
      • Koto-ku, Tokyo, Japan
        • Cancer Institute Hospital of Jfcr

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with advanced or metastatic solid tumor
  2. Patients with ECOG performance status of 0 or 1
  3. Patients with a life expectancy of at least 3 months

Exclusion Criteria:

  1. Patients with severe complication
  2. Patients judged to be incapable of providing consent for reasons such as concurrent dementia

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ONO-7914
Drug: ONO-7914
Specified dose on specified days
Experimental: ONO-7914+ONO-4538
Drug: ONO-4538
Specified dose on specified days
Drug: ONO-7914
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose Limiting Toxicity
Time Frame: 28 days
28 days
Adverse Events as assessed by CTCAE v5.0
Time Frame: Up to 28 days after the completion of treatment period
Up to 28 days after the completion of treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of ONO-7914
Time Frame: Up to 21 days after the first treatment
Up to 21 days after the first treatment
Urine concentration of ONO-7914
Time Frame: Up to 24 hours after the first treatment
Up to 24 hours after the first treatment
Serum concentration of ONO-4538
Time Frame: Up to 28 days after the completion of treatment period
Up to 28 days after the completion of treatment period

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)

February 8, 2022

Primary Completion (Actual)

February 26, 2025

Study Completion (Actual)

February 26, 2025

Study Registration Dates

First Submitted

July 21, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 2, 2024

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

June 1, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-7914-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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