Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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

ONO-4538

Ohyama Yukiya

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.

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

Ceoi：Serum concentrations immediately after the end of continuous administration

Response Evaluation Criteria In Solid Tumors Criteria (ver 1.0) was used for this Outcome Measure.

Please see the reference for the detailed description. Therasse, Arbuck et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-16.

Ono Pharmaceutical Co. Ltd

Administer ONO-4538 1mg/kg as an intravenous infusion over ≥1 hour

ONO-4538 1mg/kg Cohorts

Administer ONO-4538 3mg/kg as an intravenous infusion over ≥1 hour

ONO-4538 3mg/kg Cohorts

Administer ONO-4538 10mg/kg as an intravenous infusion over ≥1 hour

ONO-4538 10mg/kg Cohorts

Administer ONO-4538 20mg/kg as an intravenous infusion over ≥1 hour

ONO-4538 20mg/kg Cohorts

Total

Age, Categorical

Sex: Female, Male

ECOG PERFORMANCE STATUS 0：Fully active, able to carry on all pre-disease performance without restriction

1：Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work

Performance Status（ECOG）

The stage IV：The cancer has spread to nearby lymph nodes or to organs. The stage IVb：The cancer has spread to distant organs.

Spots Global Cancer Trial Database for ONO-4538 Phase I Study in Patients With Advanced Malignant Solid Tumors in Japan

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Study Description

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