A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Study Investigating AGEN1777 as a Single-Agent and in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors

Conditions
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Advanced Cancer

Intervention / Treatment
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* Drug: AGEN1777
* Drug: a PD-1 inhibitor


Participation Criteria
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Eligibility Criteria
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Key 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Dose escalation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monotherapy with AGEN1777<br>3+3 Dose escalation of AGEN1777 will be administered by Intravenous (IV) infusion every 3 weeks (each cycle is 21 days [3 weeks]). | Drug: AGEN1777<br>* An immunoglobulin gamma (IgG1) antibody<br>|
| Experimental: AGEN1777 in combination with a PD-1 inhibitor<br>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. | Drug: AGEN1777<br>* An immunoglobulin gamma (IgG1) antibody<br>Drug: a PD-1 inhibitor<br>* Anti-programmed cell death protein 1 (Anti-PD-1) antibody monoclonal antibody<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 | 
| 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 | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solid Tumors, Dose Escalation, Monotherapy, Combination Therapy, Anti-PD-1, Undisclosed Target