JPRN-jRCT2080225058RecruitingPhase 1
A PHASE Ia/Ib OPEN-LABEL, DOSE-ESCALATION STUDY OF THE SAFETY AND PHARMACOKINETICS OF STA551 AS A SINGLE AGENT AND IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC SOLID TUMORS
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 233
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •- 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
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