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Balstilimab Clinical Trials

20 actively recruiting trials across 13 locations

▲ +3 trials since August 2026

Also known as: AGEN 2034, AGEN-2034, AGEN2034, AGEN2034, anti-PD-1 antibody, BAL +3 more

Pipeline

Early 1: 1Phase 1: 3Phase 2: 12Phase 3: 1Phase 1/2: 2Phase 2/3: 1

Top Sponsors

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins2
  • National Cancer Institute (NCI)2
  • Memorial Sloan Kettering Cancer Center2
  • City of Hope Medical Center2
  • Weill Medical College of Cornell University1

Indications

  • Cancer20
  • Colorectal Cancer4
  • Liver Disease2
  • Microsatellite Stable Rectal Carcinoma2
  • Metastatic Pancreatic Cancer2

Other4 trials

Assessment of the Safety and Efficacy of Balstilimab for the Treatment of Relapsed/Refractory Lymphomas (IMMONC0001)
Phase 2
Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas
Phase 3
Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations
Phase 2/3
Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)
Phase 2

Baltimore, Maryland2 trials

Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Phase 1/2
KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer

Sidney Kimmel Comprehensive Cancer Center

Phase 1

Boston, Massachusetts2 trials

Botensilimab, Balstilimab, and SBRT in Colorectal Cancer

Massachusetts General Hospital

Early 1
RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS/pMMR Early Rectal Cancer

Brigham and Women's Hospital

Phase 2

Basking Ridge, New Jersey2 trials

A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Phase 2
A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Phase 2

Goodyear, Arizona1 trial

Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3

CTCA at Western Regional Medical Center

Phase 2

Duarte, California1 trial

FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery

City of Hope Medical Center

Phase 2

Fullerton, California1 trial

Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer

Saint Jude Medical Center / Providence Medical Foundation

Phase 1

Orange, California1 trial

rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG and DMG

Children's Health Orange County (CHOC)

Phase 1

New Haven, Connecticut1 trial

Testing the Safety and Feasibility of Immunotherapy Drugs, Botensilimab and Balstilimab, Before Surgery for Clear Cell Renal Cell Carcinoma, NEO RoBOT Trial

Yale University Cancer Center LAO

Phase 2

Miami, Florida1 trial

The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation

University of Miami

Phase 2

Chicago, Illinois1 trial

Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma

Northwestern University

Phase 2

New Orleans, Louisiana1 trial

Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Cancer, Combat Trial

Ochsner Medical Center Jefferson

Phase 2

New York, New York1 trial

Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases

Weill Cornell Medicine/NewYork-Presbyterian Hospital

Phase 2

Houston, Texas1 trial

A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab

MD Anderson Cancer Center

Phase 1/2

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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