A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05025085
• Other study ID #: CA115-P01
• Secondary ID: C-1400-01
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 4, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: September 30, 2025
• Est. primary completion date: July 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Cancer

Intervention

Drug:
• AGEN1777
An immunoglobulin gamma (IgG1) antibody
• a PD-1 inhibitor
Anti-programmed cell death protein 1 (Anti-PD-1) antibody monoclonal antibody

Locations

Country	Name	City	State
United States	Local Institution - 072	Cincinnati	Ohio
United States	University of Cincinnati Cancer Center	Cincinnati	Ohio
United States	Local Institution - 164	Dallas	Texas
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	MD Anderson Cancer Center Thoracic-Head & Neck Med Onc	Houston	Texas
United States	Providence Cancer Institute	Portland	Oregon
United States	Lifespan Cancer Institute	Providence	Rhode Island
United States	Local Institution - 0001	Providence	Rhode Island
United States	Local Institution - 024	Southfield	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Agenus Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)		Up to 2 years and 90 days
Secondary	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)
Secondary	Serum AGEN1777 Anti-Drug Antibody (ADA) Determination		Day 1 of Cycle 1 (Cycle = 21 days) through Day 1 of Cycle 5. Incidence of ADA
Secondary	Serum a PD-1 inhibitor Anti-Drug Antibody (ADA) Determination		Day 1 Up to End of Treatment (up to 2 years)
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.

External Links

•   BMS Clinical Trial Information