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Balstilimab · AGEN-2034

Monoclonal antibody · Antagonist of PD-1 (PDCD1) · developed by Agenus

Phase 2/3 Most advanced trial
AGEN Developer
7 Registered trials

What is Balstilimab?

Balstilimab is a monoclonal antibody that binds to PD-1 on T cells, blocking its interaction with PD-L1 and restoring immune function through T-cell activation. It is studied in multiple solid tumors including colorectal, gastric, breast, cervical, and pancreatic cancers.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as
AGEN-2034, Anti-PD-1, Balstilmab, Balstililmab
Drug type
Monoclonal antibody
Targets
PD-1 (PDCD1)
Mechanism
Antagonist of PD-1 (PDCD1)
Pathways
T-cell activation, immune checkpoint inhibition
Therapy area
Oncology
Developer
Agenus Inc. (AGEN)
FDA status
Investigational, not approved in the US. Most advanced trial: Phase 2/3
UNII
1Q2QT5M7EO

🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT06279130 Phase 2/3 Resectable MMR-deficient Solid Tumors Recruiting AGEN
NCT04943627 Phase 3 Advanced Cancer Withdrawn AGEN
NCT05318469 Phase 1/2 Anatomic Stage IV Breast Cancer AJCC v8 Recruiting AGEN
NCT05205330 Phase 1/2 Refractory Metastatic Colorectal Cancer Active not recruiting AGEN
NCT05033132 Phase 2 Cervical Cancer Withdrawn AGEN
NCT06095674 Phase 1 Cervical Cancer Unknown AGEN
NCT06751524 N/A Colorectal Cancer (CRC) Available AGEN

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Anatomic Stage IV Breast Cancer AJCC v8Gastric CancerMetastatic GI CancersMetastatic Microsatellite-stable Colorectal CancerMetastatic Triple-Negative Breast CarcinomaMismatch Repair Protein ProficientRefractory Metastatic Colorectal CancerResectable MMR-deficient Solid TumorsResectable MMR-proficient Solid TumorsSolid TumorAdvanced CancerCervical CancerColorectal Cancer (CRC)Hepatocellular Carcinoma (HCC)

Other drugs acting on PDCD1

More from Agenus

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the AGEN page.

Follow AGEN, the company behind Balstilimab

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.