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

NCT02261285

ONO-4538-13

Details and patient eligibility

About

The objective of the study is to investigate the pharmacokinetics 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

• Male or female ≥ 20 years of age
• Histologically or cytologically confirmed solid tumor
• Patients with advanced or recurrent solid tumors who are refractory or intolerant to standard therapy or for whom no appropriate treatment is available
• ECOG Performance Status is 0 to 1

Exclusion criteria

• Current or prior severe hypersensitivity to another antibody product
• Multiple primary cancers

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential 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, single dose

Treatment:

Drug: ONO-4538

ONO-4538 3mg/kg

Experimental group

Description:

ONO-4538 water-soluble injection, 100 mg/vial, 3mg/kg, single dose

Treatment:

Drug: ONO-4538

ONO-4538 10mg/kg

Experimental group

Description:

ONO-4538 water-soluble injection, 100 mg/vial, 10mg/kg, single dose

Treatment:

Drug: ONO-4538