{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":[["botensilimab","balstilimab"],["botensilimab"]],"indication":"advanced cancer","name":"NCT03860272","nct_id":"NCT03860272","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03860272. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"3+3 Dose escalation: botensilimab, every 3 weeks, starting at dose level 0.1 milligrams/kilogram (mg/kg) up to 4 mg/kg, administered intravenously (IV) for up to 2 years.","label":"3-Week Monotherapy","type":"EXPERIMENTAL"},{"description":"3+3 Dose escalation: botensilimab, every 6 weeks, starting at dose level 1 mg/kg up to 4 mg/kg, administered IV for up to 2 years.","label":"6-Week Monotherapy","type":"EXPERIMENTAL"},{"description":"3+3 Dose escalation: balstilimab, every 2 weeks, at dose level 3 mg/kg in combination with botensilimab, every 6 weeks, starting at dose level 0.1 mg/kg up to 4 mg/kg, administered IV for up to 2 years. Participants enrolled at sites in the United Kingdom (UK) may have the option for extended treatment. An additional cohort will investigate balstilimab, every 3 weeks, at 450 mg in combination with botensilimab every 6 weeks, at 150 mg, administered IV for up to 2 years.","label":"6-Week Combination Therapy","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2027-12","type":"ESTIMATED"},"conditions":["Advanced Cancer","Angiosarcoma","Colorectal Cancer Without Liver Metastases","Endometrial Cancer","Fibrolamellar Carcinoma","Non-small-cell Lung Cancer","Ovarian Cancer","Prostate Cancer"],"enrollment":{"count":499,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Botensilimab","otherNames":["AGEN1181","Anti-CTLA-4"],"type":"DRUG"},{"name":"Balstilimab","otherNames":["AGEN2034","Anti-PD-1"],"type":"DRUG"}],"last_update":"2026-03-30","lead_sponsor":"Agenus Inc.","official_title":"A Phase 1 Study of AGEN1181, an Fc-Engineered Anti-CTLA-4 Monoclonal Antibody as Monotherapy and in Combination With AGEN2034 (Balstilimab), an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE1"],"primary_completion_date":{"date":"2025-01-13","type":"ACTUAL"},"primary_outcomes":[{"measure":"Incidence Of Treatment-emergent Adverse Events (TEAEs)","timeFrame":"First dose through 90 days following last study dose (up to 2 years)"},{"measure":"DLT Of Botensilimab","timeFrame":"First 28 days of treatment"},{"measure":"RP2D Of Botensilimab","timeFrame":"First dose through 90 days following last study dose"}],"references":[{"citation":"Bengala E, Santini D, Picone V. Refractory microsatellite-stable metastatic colorectal cancer: a comparison between botensilimab + balstilimab and current standard of care. Immunooncol Technol. 2025 Nov 28;29:101558. doi: 10.1016/j.iotech.2025.101558. eCollection 2026 Mar.","pmid":"41502912","type":"DERIVED"},{"citation":"Wilky BA, Schwartz GK, Gordon MS, El-Khoueiry AB, Bullock AJ, Henick B, Agulnik M, Singh A, Mahadevan D, Stebbing J, Delepine C, Chand D, Avagyan M, Wu W, Johnson B, Grossman JE, O'Day S, Trent JC, Jones RL, Tsimberidou AM. Botensilimab (Fc-enhanced anti-cytotoxic lymphocyte-association protein-4 antibody) Plus Balstilimab (anti-PD-1 antibody) in Patients With Relapsed/Refractory Metastatic Sarcomas. J Clin Oncol. 2025 Apr 10;43(11):1358-1368. doi: 10.1200/JCO-24-02524. Epub 2025 Jan 27.","pmid":"39869830","type":"DERIVED"},{"citation":"Bullock AJ, Schlechter BL, Fakih MG, Tsimberidou AM, Grossman JE, Gordon MS, Wilky BA, Pimentel A, Mahadevan D, Balmanoukian AS, Sanborn RE, Schwartz GK, Abou-Alfa GK, Segal NH, Bockorny B, Moser JC, Sharma S, Patel JM, Wu W, Chand D, Rosenthal K, Mednick G, Delepine C, Curiel TJ, Stebbing J, Lenz HJ, O'Day SJ, El-Khoueiry AB. Botensilimab plus balstilimab in relapsed/refractory microsatellite stable metastatic colorectal cancer: a phase 1 trial. Nat Med. 2024 Sep;30(9):2558-2567. doi: 10.1038/s41591-024-03083-7. Epub 2024 Jun 13.","pmid":"38871975","type":"DERIVED"}],"start_date":{"date":"2019-03-20","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer","url":"https://clinicaltrials.gov/study/NCT03860272"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nct03860272"}