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 Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Ono Pharmaceutical Co. Ltd
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Cmax at Single Dose
Study Overview
Brief 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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Cmax at Single Dose
Time Frame: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation
AUClast at Single Dose
Time Frame: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation
Ceoi at Multiple Doses
Time Frame: day 15
Ceoi：Serum concentrations immediately after the end of continuous administration
T1/2 at Single Dose
Time Frame: day1(before administration, 1 hour after the start of administration, and 2 and 8 hours after the end of administration), day2(24 h), day3(48 h), day4(72 h), day8, day15, and day22 or at the discontinuation
Secondary Outcomes
- Best Overall Response(up to study completion, every 4 weeks in principle)