ONO-7913 Phase I Study (ONO-7913)

Ono Pharmaceutical Co., Ltd.7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumor

Interventions

ONO-7913BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Chuo-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Dose-limiting toxicities

Number of participants with a DLT

Time frame: 28 days

Adverse events

Assessed by the NCI CTCAE v5.0 criteria

Time frame: Up to 24 months

Secondary Outcomes

Concentration vs time of ONO-7913 as single dose

PK profile

Time frame: Up to 24 months

Data from ClinicalTrials.gov

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