Advanced or Metastatic Solid Tumors
Conditions
Brief summary
The objective of the study is to evaluate the safety, tolerability, pharmacokinetics, efficacy and biomarker of ONO-4578 and combinations of ONO-4578 and ONO-4538 in subjects with advanced or metastatic solid tumors and subjects with unresectable, advanced or recurrent gastric cancer, unresectable, advanced or recurrent colorectal cancer.
Interventions
Sponsors
Ono Pharmaceutical Co. Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced or metastatic solid tumors (Part A, B) * Unresectable, advanced or recurrent gastric cancer previously treated with anti-PD-(L)1 antibodies or naive to anti-PD-(L)1 antibodies (Part C) * Unresectable, advanced or recurrent colorectal cancer(Part D) * Life expectancy of at least 3 months * Patients with ECOG performance status 0 or 1
Exclusion criteria
* Patients with severe complication * Patients with multiple primary cancers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the safety (adverse event, clinical laboratory test, 12-lead electrocardiography, chest X-ray, ECOG performance status) | Through study completion, an average of 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed serum concentration(Cmax) | Up to Cycle 1 (each cycle is 28 days) |
| Area Under the blood concentration-time Curve(AUC) | Up to Cycle 1 (each cycle is 28 days) |
| Half-life(T1/2) of ONO-4578 both alone and in combination with ONO-4538 | Up to Cycle 1 (each cycle is 28 days) |
Countries
Japan
Outcome results
None listed