ONO-4538 Phase I Study in Patients With Solid Tumor

Ono Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors; Recurrent Solid Tumors

Treatments: Drug: ONO-4538

Study type: Interventional

Funder types: Industry

Identifiers

NCT02261298

ONO-4538-14

Details and patient eligibility

About

The objective of this study is to investigate the safety, pharmacokinetics, pharmacology and efficacy of ONO-4538 administered to Korean patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available.

Enrollment: 18 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The treatment phase has been completed in the ONO-4538-13 study

Exclusion criteria

• The development of PD is identified by the principal or sub investigator according to the RECIST guideline (version 1.1) only in case in which the unplanned tumor assessment with diagnostic image is performed in the treatment phase of ONO-4538-13 study.
• It is determined that continuing the treatment is not appropriate because the worsening of clinical symptoms attributed to disease progression occurs.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

ONO-4538 1mg/kg

Experimental group

Description:

ONO-4538 water-soluble injection, 100 mg/vial, 1mg/kg, 3 times once every 2 weeks in each 6-week cycle

Treatment:

Drug: ONO-4538

ONO-4538 3mg/kg

Experimental group

Description:

ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, 3 times once every 2 weeks in each 6-week cycle

Treatment:

Drug: ONO-4538

ONO-4538 10mg/kg

Experimental group

Description:

ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, 3 times once every 2 weeks in each 6-week cycle

Treatment:

Drug: ONO-4538