A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors

October 14, 2025 updated by: Agenus Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • START Midwest
      • Grand Rapids, Michigan, United States, 49546
        • Local Institution - 165
      • Southfield, Michigan, United States, 48075
        • Local Institution - 024
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati Cancer Center
      • Cincinnati, Ohio, United States, 45267-0558
        • Local Institution - 072
    • Oregon
      • Portland, Oregon, United States, 97213
        • Providence Cancer Institute
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Lifespan Cancer Institute
      • Providence, Rhode Island, United States, 02903
        • Local Institution - 0001
    • Texas
      • Dallas, Texas, United States, 75251
        • Mary Crowley Cancer Research
      • Dallas, Texas, United States, 75230
        • Local Institution - 164
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center Thoracic-Head & Neck Med Onc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Monotherapy with AGEN1777
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
An immunoglobulin gamma (IgG1) antibody
Experimental: AGEN1777 in combination with a PD-1 inhibitor
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
An immunoglobulin gamma (IgG1) antibody
Drug: a PD-1 inhibitor
Anti-programmed cell death protein 1 (Anti-PD-1) antibody monoclonal antibody

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Day 1 through Day 21
Day 1 through Day 21
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to 2 years and 90 days
Up to 2 years and 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum Observed Concentration at Steady State (Cmax-ss) of Serum AGEN1777 and a PD-1 inhibitor
Time Frame: Day 1 Up to End of Treatment (up to 2 years)
Day 1 Up to End of Treatment (up to 2 years)
Serum AGEN1777 Anti-Drug Antibody (ADA) Determination
Time Frame: Day 1 of Cycle 1 (Cycle = 21 days) through Day 1 of Cycle 5. Incidence of ADA
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
Time Frame: Day 1 Up to End of Treatment (up to 2 years)
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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.
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
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Agenus Inc.

Collaborators

Agenus Inc.

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2021

Primary Completion (Actual)

July 11, 2023

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Estimated)

October 15, 2025

Last Update Submitted That Met QC Criteria

October 14, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA115-P01
  • C-1400-01 (Other Identifier: Agenus Inc.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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