Advanced or Metastatic Solid Tumors
Conditions
Brief summary
To evaluate the tolerability and safety of ONO-7475 monotherapy and combinations with ONO-4538 in patients with advanced or metastatic solid tumors
Interventions
DRUGONO-7475
ONO-7475 specified dose on specified days
DRUGONO-7475 + ONO-4538
ONO-7475+ONO-4538 specified dose on specified days
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with histologically or cytologically confirmed advanced or metastatic solid tumors * ECOG Performance Status 0～1 * Patients with life expectancy of at least 3 months
Exclusion criteria
* Patients with history of severe allergy * Patients with multiple cancers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of paticipants with dose-limiting toxicities during the DLT evaluation period | 28 days |
| Incidence and severity of adverse events as assessed by CTCAE v4.0 to determine the tolerability and safety | Through study completion, an average of 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (Cmax) | Through study completion | Assessment of the maximum plasma concentration of ONO-7475 both alone and in combination with ONO-4538 |
| Pharmacokinetics (Tmax) | Through study completion | Assessment of the time to reach maximum observed plasma concentration of ONO-7475 both alone and in combination with ONO-4538 |
| Pharmacokinetics (AUC) | Through study completion | Assessment of the plasma area under the curve of ONO-7475 both alone and in combination with ONO-4538 |
Countries
Japan
Outcome results
None listed