A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors
- Conditions
- Advanced Cancer
- Registration Number
- NCT05025085
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Key Inclusion Criteria:<br><br> 1. Histologically or cytologically confirmed diagnosis of metastatic or locally<br> advanced solid tumor for which no acceptable standard therapy available or<br> progressed on or after standard therapies.<br><br> 2. Measurable disease on baseline imaging based on Response Evaluation Criteria in<br> Solid Tumors version 1.1 (RECIST 1.1).<br><br> 3. Life expectancy of at least 3 months and an Eastern Cooperative Oncology Group<br> (ECOG) performance status of 0 or 1.<br><br>Key Exclusion Criteria:<br><br> 1. Active infection requiring treatment.<br><br> 2. Lack of recovery for participants who had major surgical procedure within 4 weeks<br> prior to first dose of protocol therapy.<br><br> 3. Clinically significant cardiovascular disease: cerebral vascular accident/stroke or<br> myocardial infarction within 6 months of enrollment, unstable angina, congestive<br> heart failure (New York Heart Association class = II), or serious uncontrolled<br> cardiac arrhythmia requiring medication.<br><br> 4. Corrected QT interval (QTc) (corrected for heart rate using Fridericia's formula<br> prolongation) >480 msec at screening except for right bundle branch block.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants with Dose-Limiting Toxicities (DLT) of AGEN1777 as a Single-Agent and in Combination with a PD-1 inhibitor;Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
- Secondary Outcome Measures
Name Time Method Maximum Observed Concentration at Steady State (Cmax-ss) of Serum AGEN1777 and a PD-1 inhibitor;Serum AGEN1777 Anti-Drug Antibody (ADA) Determination;Serum a PD-1 inhibitor Anti-Drug Antibody (ADA) Determination;Complete Response (CR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Based on Investigator's assessment;Partial Response (PR) per RECIST v1.1 Based on Investigator's Assessment;Duration of Response (DOR) per RECIST v1.1 Based on Investigator's Assessment;Stable Disease (SD) per RECIST v1.1 Based on Investigator's Assessment