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

Expanded Access for Cancer Treatment With Balstilimab (AGEN2034), Either as Monotherapy, or as Used in Combination With Zalifrelimab (AGEN1884)

Status
AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT05572970
Enrollment
Unknown
Registered
2022-10-10
Start date
Unknown
Completion date
Unknown
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Balstilimab, AGEN2034, Zalifrelimab, AGEN1884, Monotherapy

Brief 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.

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.

Interventions

DRUGBalstilimab

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

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

Sponsors

Agenus Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

\-

Countries

United States

Contacts

CONTACTAgenus, Inc.
clinicaltrialinfo@Agenusbio.com781-674-4265
STUDY_DIRECTORMedical Director

Agenus Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026