NSCLC, Solid Tumor
Conditions
Brief summary
This study is to evaluate the tolerability and safety of ONO-7428 in participants with unresectable advanced or recurrent solid tumors.
Interventions
DRUGONO-7428
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. \[Backfill cohort only\] Participants with histologically or cytologically confirmed Stage IIIB, IIIC, IV, or recurrent NSCLC according to UICC-TNM classification. 2. Participants who are refractory or intolerant to standard therapy. 3. Participants with a tumor type for which anti-PD-(L)1 antibodies have been approved and who have previously treated with anti-PD-(L)1 antibody containing regimen. 4. Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1. 5. Participants with tumor tissue samples available for biomarker testing.
Exclusion criteria
1. Participants with a complication or history of severe hypersensitivity to any other antibody drugs. 2. Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease 3. Participants with severe peritoneal dissemination. 4. Participants with pericardial fluid, pleural effusion, or ascites requiring treatment. 5. Participants with uncontrolled tumor-related pain. 6. Participants with active or history of interstitial lung disease or pulmonary fibrosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicities（DLT） | 21 days |
| Adverse event (AE) | Up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Cmax | Up to 2 years |
| Tmax | Up to 2 years |
| Area under the Plasma Concentration versus Time Curve (AUC) | Up to 2 years |
| Ctrough | Up to 2 years |
| Objective Response Rate (ORR) | Up to 2 years |
| Disease Control Rate (DCR) | Up to 2 years |
| Overall Survival (OS) | Up to 2 years |
| Progression-Free Survival (PFS) | Up to 2 years |
| Duration of Response (DOR) | Up to 2 years |
| Time to Response (TTR) | Up to 2 years |
| Best Overall Response (BOR) | Up to 2 years |
| Percent change from baseline in the sum of diameters of target lesions | Up to 2 years |
| Best reduction percent change from baseline in the sum of diameters of target lesions | Up to 2 years |
Countries
Japan
Contacts
STUDY_DIRECTORProject Leader
Ono Pharmaceutical Co., Ltd.
Outcome results
None listed