This trial is active, not recruiting.

Condition malignant solid tumor
Treatment ono-4538
Phase phase 1
Target PD-1
Sponsor Ono Pharmaceutical Co. Ltd
Start date January 2009
End date September 2010
Trial size 24 participants
Trial identifier NCT00836888, ONO-4538-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
1mg/kg, 3mg/kg, 10mg/kg and 20mg/kg ONO-4538 infusion cohorts

Primary Outcomes

Evaluation of the safety (adverse event, clinical laboratory test, vital sign measurement, 12-lead electrocardiography, chest X-ray, ECOG performance status)
time frame: Up to study completion, every 2 weeks in principle
Evaluation of the pharmacokinetics
time frame: up to study completion, each visit in principle after the second administration, more frequently at the first administration

Secondary Outcomes

Evaluation of pharmacodynamics
time frame: up to study completion, every 4 weeks in principle
Exploratory evaluation of efficacy (tumor response, tumor markers)
time frame: up to study completion, every 4 weeks in principle

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Histological or cytological diagnosis of solid tumor with at least one measurable lesion of ≥ 10mm. - Tumor must be advanced or recurrent which is refractory to standard therapies or for which no alternative, appropriate therapy exists. - ECOG Performance Status of 0-1 - Life expectancy ≥ 3 months - Other inclusion criteria as specified in the study protocol Exclusion Criteria: - History of severe hypersensitivity reactions to other antibodies. - Residual adverse reactions or effect of prior therapy, which deemed to affect the safety evaluation of the study drug by the investigator or subinvestigator. - Two or more synchronous tumors, except for adequately treated basal cell cancer or cancer in situ, or superficial bladder cancer, or any other cancers from which the patient has been disease-free for at least 5 years. - Patients with any active autoimmune disease or a documented history of chronic or recurrent autoimmune disease, or current medical condition that requires systemic immunosuppressive doses of steroids or other immunosuppressive medications. - Other exclusion criteria as specified in the study protocol

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Ono Pharmaceutical Co. Ltd.