NCT06535009

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Feb 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

February 8, 2022

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2025

Completed
Last Updated

June 4, 2025

Status Verified

May 1, 2025

Enrollment Period

3.1 years

First QC Date

July 21, 2024

Last Update Submit

June 1, 2025

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

  • Dose Limiting Toxicity

    28 days

  • Adverse Events as assessed by CTCAE v5.0

    Up to 28 days after the completion of treatment period

Secondary Outcomes (3)

  • Plasma concentration of ONO-7914

    Up to 21 days after the first treatment

  • Urine concentration of ONO-7914

    Up to 24 hours after the first treatment

  • Serum concentration of ONO-4538

    Up to 28 days after the completion of treatment period

Study Arms (2)

ONO-7914

EXPERIMENTAL
Drug: ONO-7914

ONO-7914+ONO-4538

EXPERIMENTAL
Drug: ONO-7914Drug: ONO-4538

Interventions

ONO-7914DRUG

Specified dose on specified days

ONO-7914ONO-7914+ONO-4538
ONO-4538DRUG

Specified dose on specified days

ONO-7914+ONO-4538

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

Location

MeSH Terms

Interventions

Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Project Leader

    Ono Pharmaceutical Co. Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2024

First Posted

August 2, 2024

Study Start

February 8, 2022

Primary Completion

February 26, 2025

Study Completion

February 26, 2025

Last Updated

June 4, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)