Study of ONO-7914 Alone and in Combination With ONO-4538 in Patients With Solid Tumors

Phase 1TerminatedNCT06535009

Ono Pharmaceutical Co., Ltd.25 enrolled

Overview

This study is dose escalation study to evaluate the tolerability and safety of ONO-7914 alone and in combination with ONO-4538 in patients with advanced or metastatic solid tumors

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumor

Interventions

ONO-7914DRUG

Specified dose on specified days

ONO-4538DRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients with advanced or metastatic solid tumor 2. Patients with ECOG performance status of 0 or 1 3. Patients with a life expectancy of at least 3 months Exclusion Criteria: 1. Patients with severe complication 2. Patients judged to be incapable of providing consent for reasons such as concurrent dementia

Locations (1)

Cancer Institute Hospital of JFCR

Koto-ku, Tokyo, Japan

Outcomes

Primary Outcomes

Dose Limiting Toxicity

Time frame: 28 days

Adverse Events as assessed by CTCAE v5.0

Time frame: Up to 28 days after the completion of treatment period

Secondary Outcomes

Plasma concentration of ONO-7914

Time frame: Up to 21 days after the first treatment

Urine concentration of ONO-7914

Time frame: Up to 24 hours after the first treatment

Serum concentration of ONO-4538

Time frame: Up to 28 days after the completion of treatment period

Data from ClinicalTrials.gov

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