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

Ono Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Malignant Solid Tumor

Treatments

Biological: ONO-4538

Study type

Interventional

Funder types

Industry

Identifiers

NCT00836888

ONO-4538-01

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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