Balstilimab

Phase 3Monoclonal antibody

Balstilimab is a monoclonal antibody that works as a Programmed Cell Death Protein 1 Antagonist.[2] It is being investigated across 22 indications, with its most advanced program in Phase 3.[1]

Balstilimab is one of 427 small molecule programs targeting Gastric Cancer. It is currently in Phase 3.

Indications

Total Trials

Active Trials

426

Competitors

Pipeline

Status by Indication[3][1]

Indication

Gastric CancerRecruiting

Colon AdenocarcinomaRecruiting

Ewing SarcomaNot yet recruiting

Colorectal Cancer MetastaticRecruiting

Newly Diagnosed GlioblastomaRecruiting

Metastatic Pancreatic Ductal AdenocarcinomaRecruiting

Metastatic Colon AdenocarcinomaActive, not recruiting

Newly DiagnosedRecruiting

Advanced CancerActive, not recruiting

Gastroesophageal Junction CancerRecruiting

Gastric CancerPhase 3

Recruiting

Colon AdenocarcinomaPhase 2

Recruiting

Ewing SarcomaPhase 1

Not yet recruiting

Colorectal Cancer MetastaticPhase 2

Recruiting

Newly Diagnosed GlioblastomaPhase 2

Recruiting

Metastatic Pancreatic Ductal AdenocarcinomaPhase 2

Recruiting

Metastatic Colon AdenocarcinomaPreclinical

Active, not recruiting

Newly DiagnosedPhase 1

Recruiting

Advanced CancerPhase 1

Active, not recruiting

Gastroesophageal Junction CancerPhase 2

Recruiting

Showing 10 of 22 indications

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

Balstilimab

AAgenus Inc.

Phase 3

1 2

Zofran

Novartis

Preclinical

2 3

Cabenuva

GSK

Preclinical

1 4

Norvir

AbbVie

Preclinical

1 5

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 6

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 7

Nuvigil

NNuvo Research GmbH

Preclinical

1 8

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—9

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—10

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

PreclinicalActive, not recruiting

Colorectal Adenocarcinoma

NCT05672316

Q1 2027

Phase 2Recruiting

Colorectal Cancer

NCT06300463

Q2 2027

Phase 2Recruiting

Colon Adenocarcinoma

NCT07595874

PreclinicalActive, not recruiting

Metastatic Colon Adenocarcinoma

NCT05627635

Q3 2027

Phase 2Recruiting

Gastroesophageal Junction Cancer

NCT06251973

Phase 1Recruiting

Newly Diagnosed

NCT04943848

Clinical

Trials by Indication[1]

Colorectal Cancer10 trials

A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer

Active, not recruiting·AAgenus Inc.·Phase 2·NCT05608044·234 enrolled

Combination Immunotherapy in Colorectal Cancer

Suspended·WWeill Medical College of Cornell University·Phase 2·NCT05571293·36 enrolled

Botensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable Colorectal Cancer

Withdrawn·—·Phase 2·NCT06575725

Show 7 more trials

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

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT07227636·284 enrolled

Botensilimab and Balstilimab Optimization in Colorectal Cancer

Active, not recruiting·—·Phase 2·NCT06268015·16 enrolled

Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases

Recruiting·WWeill Medical College of Cornell University·Phase 2·NCT06300463·24 enrolled

Botensilimab, Balstilimab, and SBRT in Colorectal Cancer

Not yet recruiting·MMassachusetts General Hospital·Phase 1·NCT07128355·15 enrolled

Window-of-opportunity Umbrella Platform Trial of Short-course Pre-operative Targeted Treatments in Patients With Molecularly Selected and Resectable Primary Colorectal Cancer: the UNICORN Study

Recruiting·GGruppo Oncologico del Nord-Ovest·Phase 2·NCT05845450·197 enrolled

Pooled Mutant KRAS-Targeted Long Peptide Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Adenocarcinoma

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT06411691·54 enrolled

Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma: The BATTMAN Trial

Terminated·CCanadian Cancer Trials Group·Phase 3·NCT07152821·21 enrolled

Cervical Cancer3 trials

A Phase II Study of Balstilimab Independently or in Combination With Zalifrelimab in Advanced Cervical Cancer

Withdrawn·AAgenus Inc.·Phase 2·NCT05033132

Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer (BRAVA)

Withdrawn·AAgenus Inc.·Phase 3·NCT04943627

A Phase 1/2, Open-Label, Multi-Arm Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of AGEN1884 in Combination With AGEN2034 in Subjects With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors

Completed·AAgenus Inc.·Preclinical·NCT03495882·175 enrolled

Melanoma2 trials

A Study of ONCOS-102 in Combination With Other Novel Immune-therapies in Advanced Treatment-resistant Melanoma Patients

Withdrawn·TTargovax Oy·Phase 2·NCT05561491

A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma

Active, not recruiting·AAgenus Inc.·Phase 2·NCT05529316·150 enrolled

Pancreatic Cancer2 trials

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

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1/2·NCT06782932·38 enrolled

Tg01 Vaccine / Qs-21 Stimulon™ With Or Without Balstilimab As Maintenance Therapy Following Adjuvant Chemotherapy In Patients With Resected Pancreatic Cancer

Active, not recruiting·UUniversity of Kansas Medical Center·Phase 2·NCT05638698·24 enrolled

Rectal Adenocarcinoma2 trials

A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06843434·40 enrolled

Phase II Clinical Trial of FOLFOX, Botensilimab, Plus Balstilimab in Patients With Localized Rectal Cancer

Recruiting·CCity of Hope Medical Center·Phase 2·NCT06780787·26 enrolled

24 more indications

Colorectal Adenocarcinoma2 trials

A Phase 2 Study of Microsatellite Stable Colorectal Cancer (Stage 2 or 3) With Radiographic Occult Molecular Residual Disease Treated With Botensilimab (AGEN1181; Bot) Plus Balstilimab (AGEN2034, Bal) After Established Definitive Therapy (COMBAT Study)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT07551596·20 enrolled

A Phase I/II Trial of Botensilimab, Balstilimab and Regorafenib (BBR) in Patients With Microsatellite Stable (MSS) Metastatic Colorectal Cancer Who Progressed on Prior Chemotherapy

Active, not recruiting·CCity of Hope Medical Center·Preclinical·NCT05672316·28 enrolled

Gastroesophageal Junction Cancer1 trial

A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06251973·37 enrolled

Neoadjuvant1 trial

Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations

Recruiting·TThe Netherlands Cancer Institute·Phase 2/3·NCT06279130·133 enrolled

Oropharyngeal Cancer1 trial

BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT05363709·20 enrolled

Soft Tissue Sarcoma1 trial

Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas

Recruiting·UUniversity of Colorado, Denver·Phase 2·NCT04028063·65 enrolled

Newly Diagnosed1 trial

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

Recruiting·—·Phase 1·NCT04943848·36 enrolled

Adenoid Cystic Carcinoma1 trial

Study of OBT076 Associated or Not in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma of the Head and Neck

Terminated·GGroupe Oncologie Radiotherapie Tete et Cou·Phase 1·NCT05930951·19 enrolled

Advanced Cancer1 trial

Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer

Active, not recruiting·AAgenus Inc.·Phase 1·NCT03860272·499 enrolled

Lymphoma1 trial

Assessment of the Safety and Efficacy of Balstilimab for the Treatment of Relapsed/Refractory Lymphomas (IMMONC0001)

Recruiting·IImmune Oncology Research Institute·Phase 2·NCT05891821·20 enrolled

Renal Cell Cancer1 trial

Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial

Suspended·MMichael B. Atkins, MD·Phase 2·NCT05928806·120 enrolled

Metastatic Colorectal Cancer1 trial

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

Recruiting·UUniversity of Southern California·Phase 1·NCT06336902·15 enrolled

ALS1 trial

A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab

Recruiting·IImmunoGenesis·Phase 1/2·NCT06782555·71 enrolled

Advanced Solid Tumors1 trial

Study of AGEN1571 in Participants With Advanced Solid Tumors

Completed·AAgenus Inc.·Phase 1·NCT05377528·22 enrolled

Treatment1 trial

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

Available·AAgenus Inc.··NCT05572970

Ewing sarcoma1 trial

Precision Analysis of Fusion Genes in Ewing Sarcoma (ES) and Desmoplastic Small Round Cell Tumor (DSRCT), Then EWSR1 Immunotherapy Without or With Anti-PD1 (Pembrolizumab)

Not yet recruiting·RRabi Hanna·Phase 1·NCT07695311·24 enrolled

Clear Cell Renal Cell Carcinoma1 trial

Pilot Phase II Trial Evaluating Safety and Feasibility of Neoadjuvant Botensilimab and Balstilimab in Clear Cell Renal Cell Carcinoma (NEO RoBOT)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT07516366·16 enrolled

Metastatic Colon Adenocarcinoma1 trial

A Phase I/II Clinical Trial of FOLFOX Bevacizumab Plus Botensilimab and Balstilimab (3B-FOLFOX) in Patients With MSS Metastatic Colorectal Cancer

Active, not recruiting·CCity of Hope Medical Center·Preclinical·NCT05627635·20 enrolled

Metastatic Pancreatic Ductal Adenocarcinoma1 trial

A Phase 2 Single Arm Trial of Stereotactic Body Radiation Therapy Followed by Dual Immune Checkpoint Inhibition for Patients With Metastatic Pancreatic Ductal Adenocarcinoma - The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation

Recruiting·BBenjamin Spieler·Phase 2·NCT06843551·20 enrolled

Colorectal Carcinoma1 trial

A Phase 2 Study of the Safety and Efficacy of Neoadjuvant Botensilimab in Combination With Balstilimab in the Treatment of Microsatellite Stable / Mismatch Repair Proficient Early Rectal Cancer (RECTIFY-1)

Recruiting·DDana-Farber Cancer Institute·Phase 2·NCT07735624·16 enrolled

Newly Diagnosed Glioblastoma1 trial

A Phase 2a Trial of Immune Modulation in Combination With Ultrasound-mediated Blood Brain Barrier Opening in Patients With Newly Diagnosed Glioblastoma

Recruiting·NNorthwestern University·Phase 2·NCT05864534·25 enrolled

Colorectal Cancer Metastatic1 trial

A Single-Arm, Phase II Study Evaluating Combination Balstilimab Plus Botensilimab With AgenT-797 in Previously Treated Patients With pMMR Metastatic CRC With Liver Metastases

Recruiting·DDarren Sigal, MD·Phase 2·NCT07550088·17 enrolled

Colon Adenocarcinoma1 trial

A Phase II Novel Exploratory Study to Test Neoadjuvant Immunotherapy Combinations in Patients With Resectable Colon Cancer (NEST3)

Recruiting·CCity of Hope Medical Center·Phase 2·NCT07595874·100 enrolled

Gastric Cancer1 trial

A Multicenter, Randomised, Comparative, Open-label Phase III Aiming to Compare the Survival of Patients With Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas Treated by a Combination of Immune Checkpoint Inhibitors (Botensilimab + Balstilimab) Versus the Standard of Care (FOLFOX/XELOX + Nivolumab)

Recruiting·CCentre Leon Berard·Phase 3·NCT06346197·132 enrolled

Pancreatic Cancer Metastatic1 trial

An Open-label, Phase I Trial With Expansion Cohort of Nab-Paclitaxel + Gemcitabine + Cisplatin + Botensilimab (AGEN1811) + Balsilimab (AGEN2034) + Chloroquine + Celecoxib in Patients With Previously Untreated Metastatic Pancreatic Cancer

Terminated·HHonorHealth Research Institute·Phase 1·NCT06076837·6 enrolled

Sources

References

[1]
ClinicalTrials.gov — 44 trial records for Balstilimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Balstilimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Balstilimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Agenus Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Programmed Cell Death Protein 1 Antagonist[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: AAgenus Inc.

Balstilimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Colorectal Cancer10 trials

Cervical Cancer3 trials

Melanoma2 trials

Pancreatic Cancer2 trials

Rectal Adenocarcinoma2 trials

Colorectal Adenocarcinoma2 trials

Gastroesophageal Junction Cancer1 trial

Neoadjuvant1 trial

Oropharyngeal Cancer1 trial

Soft Tissue Sarcoma1 trial

Newly Diagnosed1 trial

Adenoid Cystic Carcinoma1 trial

Advanced Cancer1 trial

Lymphoma1 trial

Renal Cell Cancer1 trial

Metastatic Colorectal Cancer1 trial

ALS1 trial

Advanced Solid Tumors1 trial

Treatment1 trial

Ewing sarcoma1 trial

Clear Cell Renal Cell Carcinoma1 trial

Metastatic Colon Adenocarcinoma1 trial

Metastatic Pancreatic Ductal Adenocarcinoma1 trial

Colorectal Carcinoma1 trial

Newly Diagnosed Glioblastoma1 trial

Colorectal Cancer Metastatic1 trial

Colon Adenocarcinoma1 trial

Gastric Cancer1 trial

Pancreatic Cancer Metastatic1 trial

References

Drug Info

Quick Facts

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