CancerNCT05572970
Expanded Access for Cancer Treatment With Balstilimab (AGEN2034) and Zalifrelimab (AGEN1884)
A study testing Balstilimab and Zalifrelimab in people with Cancer, run by Agenus Inc. at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Balstilimab and Zalifrelimab
- How many people
- Not given
- Where
- 7 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Participants must have completed predicate study protocol requirements, including prior treatment duration and follow-up.
Who cannot join
- -
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
- Available
University of Alabama at Birmingham
Birmingham, Alabama, 35249
- Available
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43212
- Available
Texas Oncology
Flower Mound, Texas, 75028
- Available
Hoag Gynecologic Oncology
Newport Beach, California, 92663
- Available
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
- Available
University of California, San Francisco Medical Center
San Francisco, California, 94158
- Available
Arizona Oncology Associates
Tucson, Arizona, 85711
About this study
Official title: Expanded Access for Cancer Treatment With Balstilimab (AGEN2034), Either as Monotherapy, or as Used in Combination With Zalifrelimab (AGEN1884)
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.
- Conditions
- Cancer
- Being tested
- Balstilimab, Zalifrelimab
- Keywords
- Balstilimab, AGEN2034, Zalifrelimab, AGEN1884, Monotherapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BalstilimabDrug
Also called AGEN2034
An anti-programmed death 1 (PD-1) monoclonal antibody.
ZalifrelimabDrug
Also called AGEN1884
An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Agenus Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Agenus Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05572970
- Sponsor's protocol ID
- C-750-EAP-01
- Status last verified
- Nov 2026
- First submitted
- 5 Oct 2022
- Last updated
- 4 Nov 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access for Cancer Treatment With Balstilimab (AGEN2034), Either as Monotherapy, or as Used in Combination With Zalifrelimab (AGEN1884)
- ClinicalTrials.gov ID
- NCT05572970
- Acronym / sponsor ID
- C-750-EAP-01
- Conditions
- Cancer
- Keywords
- Balstilimab, AGEN2034, Zalifrelimab, AGEN1884, Monotherapy
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Agenus Inc.Industry (pharma, biotech, devices)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants must have completed predicate study protocol requirements, including prior treatment duration and follow-up.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BalstilimabAlso: AGEN2034An anti-programmed death 1 (PD-1) monoclonal antibody. | Drug | – |
| ZalifrelimabAlso: AGEN1884An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Agenus Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balstilimab and Zalifrelimab in people with Cancer, run by Agenus Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Agenus, Inc. (781-674-4265, clinicaltrialinfo@Agenusbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.