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Completed

NCT Number: NCT05025085

A Study Investigating AGEN1777 in Participants 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.

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Key information

Conditions

Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 165, Grand Rapids, Michigan, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AGEN1777

Drug

An immunoglobulin gamma (IgG1) antibody

a PD-1 inhibitor

Drug

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

Primary outcomes

  1. 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

  2. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to 2 years and 90 days

Secondary outcomes

  1. 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)

  2. 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

  3. Serum a PD-1 inhibitor Anti-Drug Antibody (ADA) Determination

    Time frame: Day 1 Up to End of Treatment (up to 2 years)

  4. 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

  5. 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

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Agenus Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 27, 2021
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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