Advanced or Metastatic Solid Tumors
Conditions
Brief summary
This is a multicenter, open-label, uncontrolled, phase I study to evaluate the tolerability, safety, pharmacokinetics, and efficacy of ONO-4538HSC administered subcutaneously in participants with advanced or metastatic solid tumors. This study consists of the tolerability confirmation part to determine the recommended dose for Japanese participants by evaluating the DLTs and the expansion part to evaluate the safety and pharmacokinetics and to explore the efficacy.
Interventions
DRUGONO-4538HSC
ONO-4538HSC will be administered subcutaneously once every 4 weeks.
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient with advanced or metastatic solid tumors 2. Patients have an ECOG performance status of 0 to 1 3. Patients with a life expectancy of at least 3 months \[Tolerability confirmation part\] 4. Patients who are refractory or intolerant to standard therapy or for whom no standard therapy is available \[Expansion part\] 5. Patients who are refractory or intolerant to standard therapy, or for whom no standard therapy is available, or for whom monotherapy with intravenous nivolumab is indicated according to the package insert
Exclusion criteria
1. Patients with a complication or history of severe hypersensitivity to any antibody product 2. Patients with severe complication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicities (DLT) | 28 days |
| Adverse event (AE) | UP to 100 days after the last dose |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics（serum concentration of Nivolumab） | Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase) |
Other
| Measure | Time frame |
|---|---|
| Maximum percent change in the sum diameters of the target lesions | Through study completion, an average of 6 months |
| Overall response rate (ORR) | Through study completion, an average of 6 months |
| Disease control rate (DCR) | Through study completion, an average of 6 months |
| Overall survival (OS) | Through study completion, an average of 6 months |
| Time to response (TTR) | Through study completion, an average of 6 months |
| Duration of response (DOR) | Through study completion, an average of 6 months |
| Anti-Nivolumab antibody | Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase) |
| Anti-rHuPH20 antibody | Up to Cycle25 (each cycle is 28 days) and Post-treatment observation phase (28 days after the end of treatment phase) |
| Progression-free survival (PFS) | Through study completion, an average of 6 months |
| Best overall response (BOR) | Through study completion, an average of 6 months |
| Percentage of change in the sum of tumor diameters of target lesions | Through study completion, an average of 6 months |
Countries
Japan
Outcome results
None listed