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

NCT ID: NCT05572970

Last Updated: 2025-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

AVAILABLE

Study Classification

EXPANDED_ACCESS

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Balstilimab

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

Intervention Type DRUG

Zalifrelimab

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AGEN2034 AGEN1884

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Agenus Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Director

Role: STUDY_DIRECTOR

Agenus Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status AVAILABLE

Arizona Oncology Associates

Tucson, Arizona, United States

Site Status AVAILABLE

Hoag Gynecologic Oncology

Newport Beach, California, United States

Site Status AVAILABLE

University of California, San Francisco Medical Center

San Francisco, California, United States

Site Status AVAILABLE

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status AVAILABLE

Women & Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Site Status AVAILABLE

Texas Oncology

Flower Mound, Texas, United States

Site Status AVAILABLE

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Agenus, Inc.

Role: CONTACT

781-674-4265

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C-750-EAP-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.