CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 17 enrolled
Drug / intervention
ONO-4538biological
Likely dose
ONO-4538 1mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00836888
NCT00836888Phase 1Completed
CompareCT.gov

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

Ono Pharmaceutical Co., Ltd.·interventional·Posted Feb 4, 2009·Updated Oct 8, 2020

In Brief

A Phase 1 clinical trial evaluating ONO-4538 for Malignant Solid Tumor. Completed, enrolled 17 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Solid Tumor
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 4, 2009
Enrollment StartJan 1, 2009
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.4 years ago

Interventions

ONO-4538biological

1mg/kg, 3mg/kg, 10mg/kg and 20mg/kg ONO-4538 infusion cohorts