Trial Profile
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 of Trial:
Phase I
Latest Information Update: 09 Oct 2020
Price :
$35
*
At a glance
- Drugs Nivolumab (Primary)
- Indications Solid tumours
- Focus Adverse reactions; Pharmacokinetics
- Sponsors Ono Pharmaceutical
- 01 Nov 2018 Results of ONO-4538-01, ONO-4538-02, ONO-4538-04, ONO-4538-05, ONO-4538-06, and ON-4538-08 evaluating risk factors and the clinical course of Thyroid Dysfunction induced by nivolumab, published in the Cancer Science.
- 19 Oct 2018 Results of a pooled population pharmacokinetics and exposure-safety analysis from 9 studies, published in the Journal of Clinical Pharmacology.
- 08 Dec 2016 Results published in the Investigational New Drugs