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AvailableNCT05572970Updated Nov 4, 2026

Expanded Access for Cancer Treatment With Balstilimab (AGEN2034) and Zalifrelimab (AGEN1884)

An expanded access record providing Balstilimab and Zalifrelimab in Cancer, sponsored by Agenus Inc.. Available at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Agenus Inc. · Expanded access

Study type
Expanded access
Access type
Individual patients
Ages
18 Years and older
Sex
All
01

Study summary

This is an expanded access study for cancer treatment with balstilimab alone or in combination with zalifrelimab for an intermediate-size participant population. This study addresses the treatment needs of participants who have been previously and specifically treated with balstilimab alone or in combination with zalifrelimab in a clinical study, who have experienced a benefit from this treatment and/or wish to continue treatment, and who are eligible for treatment under this expanded access study.

Read the detailed description

This study will not exceed 100 participants. Participants will be reevaluated annually to assess the treatment benefit of zalifrelimab and/or balstilimab and thereby, continued eligibility for treatment. Under this program, treatment will be continued with balstilimab, as either monotherapy or as used in combination therapy with zalifrelimab, for participants that have previously received one or both of these investigational medicinal products in a clinical study.

02

Conditions studied

  • Cancer

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Keywords

  • Balstilimab
  • AGEN2034
  • Zalifrelimab
  • AGEN1884
  • Monotherapy
03

In context

Neoplasms

10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.

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Lead sponsor

Agenus Inc. is the lead sponsor of 31 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 3 (27%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants must have completed predicate study protocol requirements, including prior treatment duration and follow-up.

Exclusion criteria

Exclusion Criteria:

-

05

Access details

Study type
Expanded access
Access type
Individual patients

Available treatment

  • An anti-programmed death 1 (PD-1) monoclonal antibody.

    Also known as: AGEN2034

  • An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody.

    Also known as: AGEN1884

06

Where to request access

7 of 7 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35249, United States
    Available
  • Arizona Oncology Associates
    Tucson, Arizona 85711, United States
    Available
  • Hoag Gynecologic Oncology
    Newport Beach, California 92663, United States
    Available
  • University of California, San Francisco Medical Center
    San Francisco, California 94158, United States
    Available
  • The Ohio State University Wexner Medical Center
    Columbus, Ohio 43212, United States
    Available
  • Women & Infants Hospital of Rhode Island
    Providence, Rhode Island 02905, United States
    Available
  • Texas Oncology
    Flower Mound, Texas 75028, United States
    Available
07

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

08

Registry details

Key details

Study ID
NCT05572970
Lead sponsor
Agenus Inc.
Responsible party
Sponsor
First posted
Oct 10, 2022
Last update
Nov 4, 2026

Study contacts

Agenus, Inc.
Contact
clinicaltrialinfo@Agenusbio.com
781-674-4265
Medical Director
study director · Agenus Inc.
View the source record on ClinicalTrials.gov ↗

Requesting access

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