A PHASE Ia/Ib STUDY OF STA551 AS A SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH SOLID TUMORS
- Conditions
- OCALLY ADVANCED OR METASTATIC SOLID TUMORS
- Registration Number
- JPRN-jRCT2080225058
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- recruiting
- Sex
- All
- Target Recruitment
- 233
Age >= 18 years (Age >= 20 years in Japan)
- ECOG Performance Status of 0 or 1
- Adequate hematologic and end organ function
- Histologically or cytologically documented solid tumors
(Dose Escalation Cohorts)
- Standard of care has proven to be ineffective or intolerable or is considered inappropriate;
- Patients with evaluable disease per RECIST v1.1.
(Expansion Cohorts)
- STA551 in combination with an anti-PD-L1 antibody is considered an acceptable treatment option.
- Patients with measurable disease per RECIST v1.1.
- clinically significant New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, and/or unstable angina.
- Prior treatment with anti-CD137 agents
- History or complication of autoimmune disease
- Any history of a Grade 3 immune-related adverse event (irAE) that resulted in permanent discontinuation of the prior immunotherapeutic agent, or Grade 4 irAE attributed to prior anti-PD-L1/PD-1 or anti-CTLA-4 therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method