NCT00836888

ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan

ONO-4538 Phase I Study - A Single Center, Open Label, Dose Escalation Single Dose, Followed by Multiple Dose Study of ONO-4538, a Fully Human mAb to PD-1, in Patients With Advanced Malignant Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Ono Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of the safety, tolerability and pharmacokinetics (PK) of a single dose and multiple doses of ONO-4538 in Japanese patients with advanced malignant solid tumors, and exploratory evaluation of the pharmacological effect and efficacy of ONO-4538.

Conditions

• Malignant Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	ONO-4538	1mg/kg, 3mg/kg, 10mg/kg and 20mg/kg ONO-4538 infusion cohorts

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-09-01
• First posted: 2009-02-04
• Last updated: 2020-10-08
• Results posted: 2020-10-08

Locations

1 site across 1 country: Japan