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NCT05572970 Clinical Trial

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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT05572970
Other study ID # C-750-EAP-01
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date March 2024
Source Agenus Inc.
Contact Agenus, Inc.
Phone 781-674-4265
Email clinicaltrialinfo@Agenusbio.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical 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 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.

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.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants must have completed predicate study protocol requirements, including prior treatment duration and follow-up. Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Balstilimab
An anti-programmed death 1 (PD-1) monoclonal antibody.
• Zalifrelimab
An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Agenus Inc.
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