Botensilimab

Phase 3Monoclonal antibody

AAgenus Inc.

Botensilimab is one of 284 biologic programs targeting Rectal Adenocarcinoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

283

Competitors

Pipeline

Status by Indication[3][1]

Indication

Rectal AdenocarcinomaRecruiting

Ewing SarcomaNot yet recruiting

Metastatic Colorectal CancerRecruiting

Colorectal AdenocarcinomaActive, not recruiting

Colorectal CancerTerminated

Pancreatic CancerActive, not recruiting

Gastric CancerRecruiting

Gastroesophageal Junction CancerRecruiting

Advanced CancerActive, not recruiting

Advanced Pancreatic Ductal AdenocarcinomaActive, not recruiting

Rectal AdenocarcinomaPhase 2

Recruiting

Ewing SarcomaPhase 1

Not yet recruiting

Metastatic Colorectal CancerPhase 2

Recruiting

Colorectal AdenocarcinomaPhase 3

Active, not recruiting

Colorectal CancerPhase 3

Terminated

Pancreatic CancerPhase 2

Active, not recruiting

Gastric CancerPhase 3

Recruiting

Gastroesophageal Junction CancerPhase 2

Recruiting

Advanced CancerPhase 1

Active, not recruiting

Advanced Pancreatic Ductal AdenocarcinomaPhase 2

Active, not recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

307 competitors in Pancreatic Cancer

#DrugCompanyPhaseTrials

Botensilimab

AAgenus Inc.

Phase 3

1 2

Byetta

AstraZeneca

Preclinical

1 3

Ayvakit Sprinkle

MMemorial Sloan Kettering Cancer Center

Preclinical

1 4

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 5

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 6

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

1 7

Secretin-Ferring

Ferring

Preclinical

1 8

Sulfonylureas

Eli Lilly

Preclinical

1 9

Hyperpolarized 13c Pyruvate

UUniversity of Maryland, Baltimore

Preclinical

1 10

PEG-Rhg-CSF

CCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

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 2Active, not recruiting

Advanced Pancreatic Ductal Adenocarcinoma

NCT05632328

PreclinicalActive, not recruiting

Metastatic Colon Adenocarcinoma

NCT05627635

Q3 2027

Phase 2Recruiting

Gastroesophageal Junction Cancer

NCT06251973

Phase 1Not yet recruiting

Colorectal Cancer

NCT07128355

Clinical

Trials by Indication[1]

Colorectal Cancer9 trials

Botensilimab and Balstilimab Optimization in Colorectal Cancer

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

Botensilimab, Balstilimab, and SBRT in Colorectal Cancer

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

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

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

Show 6 more trials

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

Withdrawn·—·Phase 2·NCT06575725

Phase II Study of Adjuvant Botensilimab in Combination With Balstilimab in Patients With Colorectal Cancer and Persistent Circulating Tumor DNA Following Surgery and Chemotherapy

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

Advanced Cancer2 trials

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

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

Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer

Completed·AAgenus Inc.·Phase 1·NCT04121676·91 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

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

Pancreatic Cancer1 trial

A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer

Active, not recruiting·AAgenus Inc.·Phase 2·NCT05630183·81 enrolled

20 more indications

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

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

Soft Tissue Sarcoma1 trial

Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas

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

ALS1 trial

Expanded Access Program (EAP) Designed to Provide Access to Botensilimab and Balstilimab Before Regulatory Approval

Available·AAgenus Inc.··NCT06751524

Advanced Solid Tumors1 trial

Study of AGEN1571 in Participants With Advanced Solid Tumors

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

Renal Cell Cancer1 trial

Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial

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

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

Advanced Melanoma1 trial

A Multicohort, Open Label, Phase 2 Study of Botensilimab (AGEN1181) for Treatment of Advanced Melanoma Refractory to Prior Checkpoint Inhibitor Therapy

Terminated·AAgenus Inc.·Phase 2·NCT05529316·150 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

Colorectal Neoplasms1 trial

Novel Exploratory Study to Test Combination of Botensilimab and Balstilimab Immunotherapy in Resectable Colorectal Cancer Patients

Completed·WWeill Medical College of Cornell University·Phase 2·NCT05571293·26 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

Active, not recruiting·NNorthwestern University·Phase 2·NCT05864534·25 enrolled

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

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 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

Advanced Pancreatic Ductal Adenocarcinoma1 trial

A Phase 2 Study of AGEN1423, an Anti-CD73-TGFβ-Trap Bifunctional Antibody, in Combination With Botensilimab, With or Without Chemotherapy in Subjects With Advanced Pancreatic Cancer.

Active, not recruiting·BBruno Bockorny·Phase 2·NCT05632328·24 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 — 36 trial records for Botensilimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Botensilimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Botensilimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Agenus Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: AAgenus Inc.

Botensilimab

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Colorectal Cancer9 trials

Advanced Cancer2 trials

Rectal Adenocarcinoma2 trials

Colorectal Adenocarcinoma2 trials

Pancreatic Cancer1 trial

Gastroesophageal Junction Cancer1 trial

Neoadjuvant1 trial

Metastatic Colorectal Cancer1 trial

Soft Tissue Sarcoma1 trial

ALS1 trial

Advanced Solid Tumors1 trial

Renal Cell Cancer1 trial

Colorectal Carcinoma1 trial

Clear Cell Renal Cell Carcinoma1 trial

Advanced Melanoma1 trial

Colon Adenocarcinoma1 trial

Colorectal Neoplasms1 trial

Newly Diagnosed Glioblastoma1 trial

Ewing sarcoma1 trial

Metastatic Colon Adenocarcinoma1 trial

Metastatic Pancreatic Ductal Adenocarcinoma1 trial

Colorectal Cancer Metastatic1 trial

Advanced Pancreatic Ductal Adenocarcinoma1 trial

Gastric Cancer1 trial

Pancreatic Cancer Metastatic1 trial

References

Drug Info

Quick Facts

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