Phase 1 Study of ONO-7475 With and Without ONO-4538 in Subjects Advanced or Metastatic Solid Tumors
Phase 1
Completed
- Conditions
- Advanced or Metastatic Solid Tumors
- Interventions
- Drug: ONO-7475 + ONO-4538
- Registration Number
- NCT03730337
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ONO-7475 monotherapy ONO-7475 - ONO-7475 in combination with ONO-4538 ONO-7475 + ONO-4538 -
- Primary Outcome Measures
Name Time Method 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 Number of paticipants with dose-limiting toxicities during the DLT evaluation period 28 days
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (Cmax) Through study completion Assessment of the maximum 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
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
Trial Locations
- Locations (1)
Tokyo Clinical Site
🇯🇵Tokyo, Japan