ONO-7913 Phase I Study (ONO-7913)

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Biological: ONO-7913

• Registration Number: NCT04403308
• Lead Sponsor: Ono Pharmaceutical Co. Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-21
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-05-27
• Study Start: 2020-07-28
• Primary Completion: 2022-01-13
• Study Completion: 2022-01-13
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-02
• Last Update Posted: 2024-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ONO-7913 as a Single Agent	ONO-7913	-

Primary Outcome Measures

Name	Time	Method
Adverse events	Up to 24 months	Assessed by the NCI CTCAE v5.0 criteria
Dose-limiting toxicities	28 days	Number of participants with a DLT

Secondary Outcome Measures

Name	Time	Method
Concentration vs time of ONO-7913 as single dose	Up to 24 months	PK profile

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Chuo-ku, Tokyo, Japan