Advanced Cancer
Conditions
Keywords
Solid Tumors, Dose Escalation, Monotherapy, Combination Therapy, Anti-PD-1, Undisclosed Target
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.
Interventions
DRUGAGEN1777
An immunoglobulin gamma (IgG1) antibody
DRUGa PD-1 inhibitor
Anti-programmed cell death protein 1 (Anti-PD-1) antibody monoclonal antibody
Sponsors
Agenus Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dose escalation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. 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. 2. Measurable disease on baseline imaging based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). 3. Life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Key
Exclusion criteria
1. Active infection requiring treatment. 2. Lack of recovery for participants who had major surgical procedure within 4 weeks prior to first dose of protocol therapy. 3. 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. 4. Corrected QT interval (QTc) (corrected for heart rate using Fridericia's formula prolongation) \>480 msec at screening except for right bundle branch block.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Serum a PD-1 inhibitor Anti-Drug Antibody (ADA) Determination | Day 1 Up to End of Treatment (up to 2 years) |
| 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 |
| 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) |
| 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. |
| 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 |
| Serum AGEN1777 Anti-Drug Antibody (ADA) Determination | Day 1 of Cycle 1 (Cycle = 21 days) through Day 1 of Cycle 5. Incidence of ADA |
Countries
United States
Outcome results
None listed