Drugs / Botensilimab
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Botensilimab

also known as AGEN-1181

Monoclonal antibody targets CTLA4 via inhibition

Developed for
colorectal cancer · rectum adenocarcinoma · colon adenocarcinoma · colorectal adenocarcinoma · pancreatic ductal adenocarcinoma · cancer of unknown primary site · metastasis from malignant tumor of colon · non-small cell lung carcinoma
+26 more · angiosarcoma · cervical cancer · clear cell renal carcinoma · colorectal carcinoma · colorectal neoplasm · desmoplastic small round cell tumor · endometrial cancer · esophageal adenocarcinoma · Ewing sarcoma · fibrolamellar hepatocellular carcinoma · gastric adenocarcinoma · gastric cancer · gastroesophageal junction adenocarcinoma · gliosarcoma · IDH-wildtype glioblastoma · malignant pancreatic neoplasm · melanoma · metastatic malignant neoplasm · neoplasm · ovarian cancer · pancreatic adenocarcinoma · pancreatic neoplasm · prostate cancer · rectal carcinoma · renal cell carcinoma · soft tissue sarcoma
Investigated by
Agenus Inc. · National Cancer Institute (NCI) · City of Hope Medical Center · Memorial Sloan Kettering Cancer Center · Weill Medical College of Cornell University · Academic Medical Center - University of Amsterdam
+34 more · Apices Soluciones S.L. · Australasian Gastro-Intestinal Trials Group · Benjamin Spieler · Bruno Bockorny · Canadian Cancer Trials Group · CarThera · Centre Leon Berard · Dana-Farber Cancer Institute · Dutch Cancer Society · Gateway for Cancer Research · Georgetown University · Gruppo Oncologico del Nord-Ovest · HonorHealth Research Institute · Immune Oncology Research Institute · Massachusetts General Hospital · Michael B. Atkins, MD · Nelum Corp · Nicholas DeVito, MD · Northwell Health · Northwestern University · PH Research, S.L. · Private Philanthropic Funds · Rabi Hanna · Scripps Health · Scripps Health · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Stingray Therapeutics · The Little Warriors Foundation · The Netherlands Cancer Institute · UNICANCER · United States Department of Defense · University of Arizona · University of Colorado, Denver · University of Southern California

Trials 39 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 trials
Phase 0 NCT07128355 May 2026 → Jan 2027 expected metastasis from malignant tumor of colon Massachusetts General Hospital Recruiting No outcome recorded
Phase 0 NCT07193862 Dec 2025 → Apr 2028 expected colorectal cancer Northwell Health Recruiting No outcome recorded
Phase 18 trials
Phase 1 NCT07695311 Oct 2026 → Oct 2029 expected Ewing sarcoma, desmoplastic small round cell tumor Rabi Hanna Not yet recruiting No outcome recorded
Phase 1 NCT06411691 Jun 2025 → Mar 2028 expected colorectal cancer, malignant pancreatic neoplasm Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting No outcome recorded
Phase 1 NCT06336902 Jan 2025 → Jan 2027 expected colorectal adenocarcinoma University of Southern California Recruiting No outcome recorded
Phase 1 NCT06076837 Jan → Dec 2025 pancreatic adenocarcinoma HonorHealth Research Institute Terminated No outcome recorded
Phase 1 NCT06095674 Jan 2024 → Jan 2026 cervical cancer Academic Medical Center - University of Amsterdam Unknown No outcome recorded
Phase 1 NCT05377528 Jul 2022 → Dec 2024 neoplasm Agenus Inc. Completed No outcome recorded
Phase 1 NCT04121676 Sep 2019 → Feb 2024 cancer of unknown primary site Agenus Inc. Completed No outcome recorded
Phase 1 NCT03860272 Mar 2019 → Jan 2025 overdue angiosarcoma, cancer of unknown primary site, colorectal cancer, endometrial cancer +4 Agenus Inc. Active not recruiting No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT05672316 May 2023 → May 2025 overdue colorectal adenocarcinoma City of Hope Medical Center Active not recruiting No outcome recorded
Phase 1/2 NCT05627635 May 2023 → Jun 2026 overdue colon adenocarcinoma, rectum adenocarcinoma City of Hope Medical Center Active not recruiting No outcome recorded
Phase 224 trials
Phase 2 NCT07595874 Dec 2026 → May 2027 expected colon adenocarcinoma, rectum adenocarcinoma City of Hope Medical Center Recruiting No outcome recorded
Phase 2 NCT07516366 Aug 2026 → Aug 2027 expected clear cell renal carcinoma National Cancer Institute (NCI) Not yet recruiting No outcome recorded
Phase 2 NCT07551596 Aug → Sep 2026 expected colorectal adenocarcinoma National Cancer Institute (NCI) Not yet recruiting No outcome recorded
Phase 2 NCT07578337 Jul 2026 → Feb 2029 expected pancreatic neoplasm Nelum Corp Not yet recruiting No outcome recorded
Phase 2 NCT07550088 Jun 2026 → Sep 2028 expected colorectal cancer Scripps Health Not yet recruiting No outcome recorded
Phase 2 NCT07227636 Nov 2025 → Nov 2030 expected rectal carcinoma Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 2 NCT06843551 Jun 2025 → Aug 2030 expected pancreatic ductal adenocarcinoma Benjamin Spieler Recruiting No outcome recorded
Phase 2 NCT06780787 May 2025 → Nov 2027 expected rectum adenocarcinoma City of Hope Medical Center Recruiting No outcome recorded
Phase 2 NCT06843434 Feb 2025 → Feb 2028 expected rectum adenocarcinoma Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 2 NCT06589440 Nov 2024 → Sep 2027 expected colorectal cancer Stingray Therapeutics Recruiting No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT06279130 Jan 2024 → Jan 2029 expected The Netherlands Cancer Institute Recruiting No outcome recorded
Phase 32 trials
Phase 3 NCT07152821 Mar → Jul 2026 colorectal cancer Canadian Cancer Trials Group Terminated No outcome recorded
Phase 3 NCT06346197 Dec 2025 → May 2028 expected gastric cancer, metastatic malignant neoplasm Centre Leon Berard Recruiting No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
NCT06751524 Background colorectal cancer, hepatocellular carcinoma, malignant pancreatic neoplasm, melanoma +4 Agenus Inc. Available No outcome recorded

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 42 sources stand behind the page.

FieldValueCited text
Known as Botensilimab Botensilimab, an Fc-enhanced anti-CTLA-4 antibody (FcE-aCTLA-4), has shown durable activity in "cold" and immunotherapy-refractory cancers.” PMID 39028616 Nov 2024
39

“SR-8541A administered orally in combination with intravenous botensilimab and balstilimab” NCT06589440

“Anti-CTLA-4 antibody botensilimabNCT06095674

NCT07152821

NCT05627635

NCT06575725

NCT06843434

NCT07551596

NCT06751524

NCT07193862

NCT07695311

NCT05377528

NCT06076837

NCT05632328

NCT06346197

NCT06300463

NCT07595874

NCT06268015

NCT04121676

NCT05928806

NCT05571293

NCT04028063

NCT06279130

NCT07516366

NCT05529316

NCT06843551

NCT07227636

NCT06780787

NCT05608044

NCT06411691

NCT05845450

NCT06336902

NCT05672316

NCT06251973

NCT03860272

NCT06322108

NCT05630183

NCT07550088

NCT07578337

NCT07128355

Known as AGEN-1181 ChEMBL registry synonym — accepted as the source's own label CHEMBL4650435
Action Inhibit “Botensilimab (BOT) is an Fc-enhanced multifunctional anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody designed to expand therapy to cold/poorly immunogenic...” PMID 38871975 Jun 2024
Modality Monoclonal antibody “An Fc-engineered anti-CTLA-4 monoclonal antibodyNCT03860272
Route Intravenous “AGEN2373 and botensilimab administered by IV.” NCT04121676
Target CTLA4 “Botensilimab (AGEN1181) is a novel, human, fragment-crystallizable (Fc)-engineered immunoglobulin G1 (IgG1) anti-CTLA-4 antibody” NCT04028063