We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05025085
Recruitment Status : Recruiting
First Posted : August 27, 2021
Last Update Posted : September 14, 2022
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Agenus Inc.

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 Intervention/treatment Phase
Advanced Cancer Drug: AGEN1777 Drug: a PD-1 inhibitor Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 Phase 1 Study Investigating AGEN1777 as a Single-Agent and in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors
Actual Study Start Date : October 4, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2025

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




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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05025085


Contacts
Layout table for location contacts
Contact: Agenus, Inc. Clinical Trial Information 781-674-4265 clinicaltrialinfo@agenusbio.com

Locations
Layout table for location information
United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Julie Burns    616-954-5559    Julie.burns@startmidwest.com   
Principal Investigator: Manish R. Sharma, MD         
United States, Ohio
University of Cincinnati Cancer Center Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Michael Price    513-584-7824    price2m9@ucmail.uc.edu   
Principal Investigator: Trisha Wise-Draper, MD         
United States, Oregon
Providence Cancer Institute Recruiting
Portland, Oregon, United States, 97213
Contact: Annie Stadum    503-215-3577    Anne.Stadum@providence.org   
Principal Investigator: Rachel Sanborn, MD         
United States, Rhode Island
Lifespan Cancer Institute Recruiting
Providence, Rhode Island, United States, 02903
Contact: Victoria Nelson    401-444-6217    VNelson@Lifespan.org   
Principal Investigator: Benedito A. Carneiro, MD         
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75251
Contact: Mary Crowley Referral Office    972-566-3000    referral@marycrowley.org   
Principal Investigator: James Strauss, MD         
MD Anderson Cancer Center Thoracic-Head & Neck Med Onc Recruiting
Houston, Texas, United States, 77030
Contact: Jessie Jia    713-792-9801    xjia1@mdanderson.org   
Principal Investigator: Maura Gillison, MD         
Sponsors and Collaborators
Agenus Inc.
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Medical Director Agenus Inc.
Layout table for additonal information
Responsible Party: Agenus Inc.
ClinicalTrials.gov Identifier: NCT05025085    
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

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents