Solid Tumors
Conditions
Brief summary
This study is to evaluate the tolerability and safety of ONO-7429 in participants with unresectable advanced or recurrent solid tumors.
Interventions
DRUGONO-7429
Specified dose on specified days
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. Participants with histologically or cytologically confirmed unresectable advanced or recurrent solid tumors. 2. Participants who are refractory or intolerant to standard therapy. 3. Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1. 4. Participants with tumor tissue samples available for biomarker testing.
Exclusion criteria
1. Participants with a history or presence of severe hypersensitivity to any other antibody agents. 2. Participants with pericardial fluid, pleural effusion or ascites requiring treatment 3. Participants with uncontrolled tumor-related pain 4. Participants with severe peritoneal dissemination. 5. Participants with multiple primary cancers. 6. Participants with a history or presence of ILD or pulmonary fibrosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicities（DLT） | From first dose through completion of the DLT evaluation period (approximately 21 days) |
| Adverse event (AE) | Approximately 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Area under the Plasma Concentration versus Time Curve (AUC) | Approximately 6 months |
| Cmax | Approximately 6 months |
| Tmax | Approximately 6 months |
| Terminal elimination half-life（T1/2） | Approximately 6 months |
| Ctrough | Approximately 6 months |
| CL | Approximately 6 months |
| Volume of distribution at steady state（Vss） | Approximately 6 months |
| Objective Response Rate (ORR) | Approximately 6 months |
| Disease Control Rate (DCR) | Approximately 6 months |
| Best overall response（BOR） | Approximately 6 months |
| Duration of Response (DOR) | Approximately 6 months |
| Progression-Free Survival (PFS) | Approximately 6 months |
| Overall Survival (OS) | Approximately 6 months |
| Time to Response (TTR) | Approximately 6 months |
| Percent change from baseline in the sum of diameters of target lesions | Approximately 6 months |
| Best percent change from baseline in the sum of diameters of target lesions | Approximately 6 months |
Countries
Japan
Contacts
CONTACTNorth America Clinical Trial Support Desk
CONTACTInternational Clinical Trial Support Desk
STUDY_DIRECTORProject Leader
Ono Pharmaceutical Co., Ltd.
Outcome results
None listed