Clinical trial NCT05025085: A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: Solid Tumors
Dose Escalation
Monotherapy
Combination Therapy
Anti-PD-1
Undisclosed Target
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Agenus Inc.
First posted: 2021-08-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Dose escalation
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of Participants with Dose-Limiting Toxicities (DLT) of AGEN1777 as a Single-Agent and in Combination with a PD-1 inhibitor
timeFrame: Day 1 through Day 21
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to 2 years and 90 days
Secondary outcomes:
measure: Maximum Observed Concentration at Steady State (Cmax-ss) of Serum AGEN1777 and a PD-1 inhibitor
timeFrame: Day 1 Up to End of Treatment (up to 2 years)
measure: Serum AGEN1777 Anti-Drug Antibody (ADA) Determination
timeFrame: Day 1 of Cycle 1 (Cycle = 21 days) through Day 1 of Cycle 5. Incidence of ADA
measure: Serum a PD-1 inhibitor Anti-Drug Antibody (ADA) Determination
timeFrame: Day 1 Up to End of Treatment (up to 2 years)
measure: Complete Response (CR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Based on Investigator's assessment
timeFrame: 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
measure: Partial Response (PR) per RECIST v1.1 Based on Investigator's Assessment
timeFrame: 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
measure: Duration of Response (DOR) per RECIST v1.1 Based on Investigator's Assessment
timeFrame: 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.
measure: Stable Disease (SD) per RECIST v1.1 Based on Investigator's Assessment
timeFrame: 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.
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Local Institution - 165
state: Michigan
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: Southfield
country: United States
facility: Local Institution - 024
state: Michigan
city: Cincinnati
country: United States
facility: Local Institution - 072
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati Cancer Center
state: Ohio
city: Portland
country: United States
facility: Providence Cancer Institute
state: Oregon
city: Providence
country: United States
facility: Lifespan Cancer Institute
state: Rhode Island
city: Providence
country: United States
facility: Local Institution - 0001
state: Rhode Island
city: Dallas
country: United States
facility: Local Institution - 164
state: Texas
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center Thoracic-Head & Neck Med Onc
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: