NCT03730337

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2018

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

October 17, 2018

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 5, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2021

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2022

Completed
Last Updated

October 4, 2023

Status Verified

September 1, 2023

Enrollment Period

2.7 years

First QC Date

October 30, 2018

Last Update Submit

October 2, 2023

Conditions

Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

  • Number of paticipants with dose-limiting toxicities during the DLT evaluation period

    28 days

  • Incidence and severity of adverse events as assessed by CTCAE v4.0 to determine the tolerability and safety

    Through study completion, an average of 1 year

Secondary Outcomes (3)

  • Pharmacokinetics (Cmax)

    Through study completion

  • Pharmacokinetics (Tmax)

    Through study completion

  • Pharmacokinetics (AUC)

    Through study completion

Study Arms (2)

ONO-7475 monotherapy

EXPERIMENTAL
Drug: ONO-7475

ONO-7475 in combination with ONO-4538

EXPERIMENTAL
Drug: ONO-7475 + ONO-4538

Interventions

ONO-7475DRUG

ONO-7475 specified dose on specified days

ONO-7475 monotherapy
ONO-7475 + ONO-4538DRUG

ONO-7475+ONO-4538 specified dose on specified days

ONO-7475 in combination with ONO-4538

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokyo Clinical Site

Tokyo, Japan

Location

Related Publications (1)

  • Zhao X, Li Y, Yang S, Chen Y, Wu K, Geng J, Liu P, Wang Z, Dai H, Wang C. Orderly Regulation of Macrophages and Fibroblasts by Axl in Bleomycin-Induced Pulmonary Fibrosis in Mice. J Cell Mol Med. 2025 Jan;29(1):e70321. doi: 10.1111/jcmm.70321.

    PMID: 39779468DERIVED

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
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2018

First Posted

November 5, 2018

Study Start

October 17, 2018

Primary Completion

June 28, 2021

Study Completion

November 22, 2022

Last Updated

October 4, 2023

Record last verified: 2023-09

Locations

JP(1)