A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors

NCT05025085 | Completed Phase 1 FDA Drug

• 2 other identifiers: CA115-P01C-1400-01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 11

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.

Conditions

Advanced Cancer

Keywords

Solid Tumors; Dose Escalation; Monotherapy; Combination Therapy; Anti-PD-1; Undisclosed Target

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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

Study Arms (2)

Monotherapy with AGEN1777

EXPERIMENTAL

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

AGEN1777 in combination with a PD-1 inhibitor

EXPERIMENTAL

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; Drug: a PD-1 inhibitor

Interventions

AGEN1777 DRUG

An immunoglobulin gamma (IgG1) antibody

AGEN1777 in combination with a PD-1 inhibitor; Monotherapy with AGEN1777

a PD-1 inhibitor DRUG

Anti-programmed cell death protein 1 (Anti-PD-1) antibody monoclonal antibody

AGEN1777 in combination with a PD-1 inhibitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Agenus Inc.: lead

Study Sites (11)

Local Institution - 165

Grand Rapids, Michigan, 49546, United States

Location

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

Local Institution - 024

Southfield, Michigan, 48075, United States

Location

Local Institution - 072

Cincinnati, Ohio, 45267-0558, United States

Location

University of Cincinnati Cancer Center

Cincinnati, Ohio, 45267, United States

Location

Providence Cancer Institute

Portland, Oregon, 97213, United States

Location

Lifespan Cancer Institute

Providence, Rhode Island, 02903, United States

Location

Local Institution - 0001

Providence, Rhode Island, 02903, United States

Location

Local Institution - 164

Dallas, Texas, 75230, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75251, United States

Location

MD Anderson Cancer Center Thoracic-Head & Neck Med Onc

Houston, Texas, 77030, United States

Location

Related Links

• BMS Clinical Trial Information

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 27, 2021
• Study Start: October 4, 2021
• Primary Completion: July 11, 2023
• Study Completion: April 1, 2024
• Last Updated: October 15, 2025

Record last verified: 2025-10

Locations

US (11)