Clinical Trials /

ONO-7913 Phase I Study (ONO-7913)

NCT04403308

Description:

To assess the tolerability, safety, and pharmacokinetics (PK) of ONO-7913 in patients with advanced or metastatic solid cancers and explore its efficacy and biomarkers.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: ONO-7913 Phase I Study (ONO-7913)
  • Official Title: An Open-label, Uncontrolled, Dose Escalation Study in Patients With Advanced or Metastatic Solid Cancers (ONO-7913-01)

Clinical Trial IDs

  • ORG STUDY ID: ONO-7913-01
  • NCT ID: NCT04403308

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
ONO-7913ONO-7913 as a Single Agent

Purpose

To assess the tolerability, safety, and pharmacokinetics (PK) of ONO-7913 in patients with advanced or metastatic solid cancers and explore its efficacy and biomarkers.

Trial Arms

NameTypeDescriptionInterventions
ONO-7913 as a Single AgentExperimental
  • ONO-7913

Eligibility Criteria

        Inclusion Criteria:

          1. Patients with histologically or cytologically confirmed advanced or metastatic solid
             tumors

          2. ECOG Performance Status of 0-1

          3. Patients with life expectancy of at least 3 months

        Exclusion Criteria:

          1. Patients with multiple cancers

          2. Patients with history of serious allergy
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose-limiting toxicities
Time Frame:28 days
Safety Issue:
Description:Number of participants with a DLT

Secondary Outcome Measures

Measure:Concentration vs time of ONO-7913 as single dose
Time Frame:Up to 24 months
Safety Issue:
Description:PK profile

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Ono Pharmaceutical Co. Ltd

Last Updated

May 26, 2020