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NCT04403308 Clinical Trial

ONO-7913 Phase I Study (ONO-7913)

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04403308
Other study ID # ONO-7913-01
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 28, 2020
Est. completion date January 13, 2022

Study information
Verified date May 2024
Source Ono Pharmaceutical Co. Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 7
Est. completion date January 13, 2022
Est. primary completion date January 13, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• ONO-7913
ONO-7913 will be administered by intravenous continuous infusion during the designated time.

Locations
Country Name City State
Japan Local Institution Chuo-ku Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Ono Pharmaceutical Co. Ltd

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dose-limiting toxicities Number of participants with a DLT 28 days
Primary Adverse events Assessed by the NCI CTCAE v5.0 criteria Up to 24 months
Secondary Concentration vs time of ONO-7913 as single dose PK profile Up to 24 months
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