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A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors

  • Clinicaltrials.gov identifier

    NCT05025085

  • Recruitment Status

    Recruiting

  • First Posted

    August 27, 2021

  • Last update posted

    September 14, 2022

Study Description

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.

  • Condition or Disease:Advanced Cancer
  • Intervention/Treatment: Drug: AGEN1777
    Drug: a PD-1 inhibitor
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 75 participants
  • Allocation: Randomized
  • Intervention Model: Sequential Assignment
  • Intervention Model Description: Dose escalation
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors
  • Actual Study Start Date: October 2021
  • Estimated Primary Completion Date: September 2023
  • Estimated Study Completion Date: September 2025

Arms and interventions

Arm Intervention/treatment
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
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

Outcome Measures

  • Primary Outcome Measures: 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 Outcome Measures: 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. ]

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Agenus, Inc. Clinical Trial Information 781-674-4265 clinicaltrialinfo@agenusbio.com

Locations

United States, Michigan
START Midwest
Grand Rapids

United States, Ohio
University of Cincinnati Cancer Center
Cincinnati

United States, Oregon
Providence Cancer Institute
Portland

United States, Rhode Island
Lifespan Cancer Institute
Providence

United States, Texas
Mary Crowley Cancer Research
Dallas

United States, Texas
MD Anderson Cancer Center Thoracic-Head & Neck Med Onc
Houston

Sponsors and Collaborators

Agenus Inc.

Bristol-Myers Squibb

Investigators

Study Director: Medical Director Agenus Inc.

More Information

  • Responsible Party: Agenus Inc.
  • ClinicalTrials.gov Identifier: NCT05025085 History of Changes
  • Other Study ID Numbers: C-1400-01
  • First Posted: August 27, 2021 Key Record Dates
  • Last Update Posted: September 14, 2022
  • Last Verified: September 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Agenus Inc.: Solid Tumors
    Dose Escalation
    Monotherapy
    Combination Therapy
    Anti-PD-1
    Undisclosed Target