{"entity":{"id":"botensilimab","kind":"drug","name":"Botensilimab","aka":[],"tldr":"Botensilimab is an experimental monoclonal antibody from Agenus in phase 2 trials for colorectal cancer, aimed at CTLA-4.","summary":"Botensilimab (AGEN1181) is a monoclonal antibody developed by Agenus. Its target is CTLA-4 (the sponsor names CTLA-4). The sponsor states: Botensilimab is an Fc-enhanced anti-CTLA-4 monoclonal antibody designed to prime a broader anti-tumour immune response, typically studied in combination with balstilimab (anti-PD-1). ClinicalTrials.gov describes the intervention as: An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, in colorectal cancer. The largest, NCT05608044, plans to enrol 234 participants (actual) with primary completion expected 2027-09. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.","status":"phase-2","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of Botensilimab","url":"https://clinicaltrials.gov/search?intr=AGEN1181"},{"label":"Sponsor pipeline page","url":"https://agenusbio.com/pipeline/"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["colorectal"],"sections":[],"technologies":[],"targets":["ctla4"],"drugs":[],"companies":["agenus"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06589440"],"people":[],"bottlenecks":[],"keyPapers":["paper-bullock-botensilimab-balstilimab-mss-colorectal-nat-med-2024"],"journals":[],"dependsOn":[],"notes":["Colorectal cancer biomarkers: this is the one agent aimed at the microsatellite-stable majority rather than the deficient minority. With balstilimab it gave an objective response rate of 17% and disease control of 61% in 101 response-evaluable microsatellite-stable patients out of 148 treated, with no biomarker threshold beyond microsatellite stability and prior treatment (Bullock 2024)."],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"code":"AGEN1181","modality":"monoclonal antibody","mechanism":"Botensilimab is an Fc-enhanced anti-CTLA-4 monoclonal antibody designed to prime a broader anti-tumour immune response, typically studied in combination with balstilimab (anti-PD-1).","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/botensilimab/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"target":[{"id":"ctla4","kind":"target","name":"CTLA-4","route":"/targets/ctla4/"}],"company":[{"id":"agenus","kind":"company","name":"Agenus","route":"/companies/agenus/"}],"trial":[{"id":"nct07578337","kind":"trial","name":"A Clinical Study Evaluating a New Treatment Strategy for Patients With Advanced Pancreatic Cancer Who Have Not Received Prior Treatment for Advanced Disease.","route":"/trials/nct07578337/"},{"id":"nct07227636","kind":"trial","name":"A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy","route":"/trials/nct07227636/"},{"id":"nct06843434","kind":"trial","name":"A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma","route":"/trials/nct06843434/"},{"id":"nct05608044","kind":"trial","name":"A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer","route":"/trials/nct05608044/"},{"id":"nct07550088","kind":"trial","name":"BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases","route":"/trials/nct07550088/"},{"id":"nct06780787","kind":"trial","name":"FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery","route":"/trials/nct06780787/"},{"id":"nct07595874","kind":"trial","name":"Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3","route":"/trials/nct07595874/"},{"id":"nct06589440","kind":"trial","name":"Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Can","route":"/trials/nct06589440/"},{"id":"nct05864534","kind":"trial","name":"Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma","route":"/trials/nct05864534/"},{"id":"nct06300463","kind":"trial","name":"Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases","route":"/trials/nct06300463/"},{"id":"nct05845450","kind":"trial","name":"Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)","route":"/trials/nct05845450/"},{"id":"nct07735624","kind":"trial","name":"RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS/pMMR Early Rectal Cancer","route":"/trials/nct07735624/"},{"id":"nct07551596","kind":"trial","name":"Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Cancer, Combat Trial","route":"/trials/nct07551596/"},{"id":"nct06843551","kind":"trial","name":"The Miami \"EMPIRE\" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation","route":"/trials/nct06843551/"}],"paper":[{"id":"paper-bullock-botensilimab-balstilimab-mss-colorectal-nat-med-2024","kind":"paper","name":"Botensilimab plus balstilimab in relapsed/refractory microsatellite stable metastatic colorectal cancer: a phase 1 trial","route":"/key-papers/paper-bullock-botensilimab-balstilimab-mss-colorectal-nat-med-2024/"}],"roadmap":[{"id":"colorectal-roadmap","kind":"roadmap","name":"Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation","route":"/roadmaps/colorectal-roadmap/"}],"idea":[{"id":"idea-crc-mss-immunotherapy-by-biomarker-not-by-line","kind":"idea","name":"Select microsatellite stable patients for immunotherapy by a measured immune biomarker, not by how many treatments they have already failed","route":"/ideas/idea-crc-mss-immunotherapy-by-biomarker-not-by-line/"}]}}