A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors
- Registration Number
- NCT05025085
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
This study is a multicenter, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of AGEN1777 as a single agent and when used in combination with a PD-1 inhibitor in participants with advanced, metastatic solid tumors.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
- Histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumor for which no acceptable standard therapy available or progressed on or after standard therapies.
- Measurable disease on baseline imaging based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
- Life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key
Exclusion Criteria
- Active infection requiring treatment.
- Lack of recovery for participants who had major surgical procedure within 4 weeks prior to first dose of protocol therapy.
- Clinically significant cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication.
- Corrected QT interval (QTc) (corrected for heart rate using Fridericia's formula prolongation) >480 msec at screening except for right bundle branch block.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Monotherapy with AGEN1777 AGEN1777 3+3 Dose escalation of AGEN1777 will be administered by Intravenous (IV) infusion every 3 weeks (each cycle is 21 days \[3 weeks\]). AGEN1777 in combination with a PD-1 inhibitor a PD-1 inhibitor 3+3 Dose escalation of AGEN1777 in combination with a PD-1 inhibitor will be administered by IV infusion with specified dose on specified days. AGEN1777 in combination with a PD-1 inhibitor AGEN1777 3+3 Dose escalation of AGEN1777 in combination with a PD-1 inhibitor will be administered by IV infusion with specified dose on specified days.
- 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 Day 1 through Day 21 Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Up to 2 years and 90 days
- Secondary Outcome Measures
Name Time Method Maximum Observed Concentration at Steady State (Cmax-ss) of Serum AGEN1777 and a PD-1 inhibitor Day 1 Up to End of Treatment (up to 2 years) Serum AGEN1777 Anti-Drug Antibody (ADA) Determination Day 1 of Cycle 1 (Cycle = 21 days) through Day 1 of Cycle 5. Incidence of ADA Serum a PD-1 inhibitor Anti-Drug Antibody (ADA) Determination Day 1 Up to End of Treatment (up to 2 years) Partial Response (PR) per RECIST v1.1 Based on Investigator's Assessment From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity Complete Response (CR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Based on Investigator's assessment From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity Duration of Response (DOR) per RECIST v1.1 Based on Investigator's Assessment From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity. Stable Disease (SD) per RECIST v1.1 Based on Investigator's Assessment From Day 1 of Cycle 1 (each cycle is 21 days [3 weeks]) until every 9 weeks (±7 days) for 12 months, and every 12 weeks (±7 days) thereafter up to 2 years or until progressive disease or unacceptable toxicity.
Trial Locations
- Locations (11)
Local Institution - 072
🇺🇸Cincinnati, Ohio, United States
MD Anderson Cancer Center Thoracic-Head & Neck Med Onc
🇺🇸Houston, Texas, United States
Providence Cancer Institute
🇺🇸Portland, Oregon, United States
Local Institution - 164
🇺🇸Dallas, Texas, United States
Local Institution - 024
🇺🇸Southfield, Michigan, United States
University of Cincinnati Cancer Center
🇺🇸Cincinnati, Ohio, United States
Lifespan Cancer Institute
🇺🇸Providence, Rhode Island, United States
Local Institution - 0001
🇺🇸Providence, Rhode Island, United States
Mary Crowley Cancer Research
🇺🇸Dallas, Texas, United States
Local Institution - 165
🇺🇸Grand Rapids, Michigan, United States
START Midwest
🇺🇸Grand Rapids, Michigan, United States