Drugs / Botensilimab
Trials 38
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 17 trials | ||||||
| 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 → Apr 2026 overdue | colorectal adenocarcinoma | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05627635 | May 2023 → Jun 2027 expected | colon adenocarcinoma, rectum adenocarcinoma | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 224 trials | ||||||
| Phase 2 | NCT07551596 | May 2027 → Aug 2029 expected | colorectal adenocarcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT07516366 | May 2027 → Dec 2028 expected | clear cell renal carcinoma | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 2 | NCT07595874 | Dec 2026 → May 2027 expected | colon adenocarcinoma, rectum adenocarcinoma | City of Hope Medical Center | 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 | NCT06268015 | Nov 2024 → Jul 2028 expected | colorectal cancer | Nicholas DeVito, MD | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06575725 | Nov 2024 → Jan 2027 | colon adenocarcinoma, rectum adenocarcinoma | City of Hope Medical Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT05632328 | Aug 2024 → Aug 2026 overdue | pancreatic ductal adenocarcinoma | Bruno Bockorny | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06322108 | Jun 2024 → Apr 2030 expected | non-small cell lung carcinoma | Immune Oncology Research Institute | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06300463 | Mar 2024 → Dec 2026 expected | metastasis from malignant tumor of colon | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 2 | NCT06251973 | Feb 2024 → Aug 2027 expected | esophageal adenocarcinoma, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05864534 | Jan 2024 → Jul 2031 expected | IDH-wildtype glioblastoma, gliosarcoma | Northwestern University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05928806 | Sep 2023 → Nov 2026 | renal cell carcinoma | Michael B. Atkins, MD | Suspended | No outcome recorded |
| Phase 2 | NCT05845450 | May 2023 → May 2027 expected | colorectal carcinoma | Gruppo Oncologico del Nord-Ovest | Recruiting | No outcome recorded |
| Phase 2 | NCT05630183 | Mar 2023 → Jan 2026 | pancreatic ductal adenocarcinoma | Agenus Inc. | Completed | No outcome recorded |
| Phase 2 | NCT05571293 | Mar 2023 → Nov 2024 | colorectal neoplasm | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 2 | NCT05529316 | Dec 2022 → Feb 2028 expected | melanoma | Agenus Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05608044 | Nov 2022 → Sep 2027 expected | colorectal cancer | Agenus Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04028063 | Jan 2020 → Apr 2027 expected | soft tissue sarcoma | University of Colorado, Denver | Active not 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 Stop: Business |
| Phase 3 | NCT06346197 | Dec 2025 → May 2028 expected | gastric cancer, metastatic malignant neoplasm | Centre Leon Berard | Recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| — | NCT06751524 Background | — | colorectal cancer, hepatocellular carcinoma, malignant pancreatic neoplasm, melanoma +4 | Agenus Inc. | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 40
| Date | Issuer | Release |
|---|---|---|
| 2026-10-08 | Agenus Inc. | Regulatory Armenia Grants First Marketing Authorizations for Agenus’ BOT+BAL in Previously Treated MSS Metastatic Colorectal Cancer agenusbio.com ↗
These are the first marketing authorizations for either medicine anywhere in the world. |
| 2026-10-03 | Agenus Inc. | Results Agenus Reports 48% Estimated Three-Year Survival With BOT+BAL in Recurrent Ovarian Cancer at IGCS 2026 agenusbio.com ↗
Among patients evaluable for efficacy, three-year overall survival was 48% (n=35), unchanged from the two-year estimate, suggesting durable clinical benefit in this population. |
| 2026-08-28 | Agenus Inc. | Results Agenus Announces Peer-Reviewed Publication Linking BOT+BAL’s Durable Survival in MSS Metastatic Colorectal Cancer to Its Distinct Immune-Priming Mechanism agenusbio.com ↗
Mature 123 patient analysis reports 21.2-month median overall survival and 33% three-year overall survival in heavily pretreated MSS mCRC without active liver metastases |
| 2026-08-26 | Agenus Inc. | Results Agenus Announces Updated NEST Phase 2 Publication Reporting Deep Pathologic Responses and No Observed Recurrences with Neoadjuvant BOT+BAL in Resectable Colon Cancer agenusbio.com ↗
At the March 31, 2026 data cutoff, no colorectal cancer recurrences had been observed, with median follow-up of 32.2 months in NEST-1 and 23.5 months in NEST-2. |
| 2026-07-06 | Agenus Inc. | Results Agenus Reports Landmark BOT+BAL Data Showing 33% Three-Year Overall Survival in Refractory MSS Metastatic Colorectal Cancer Without Active Liver Metastases at ESMO GI 2026 agenusbio.com ↗
With extended follow-up, median overall survival was 21.2 months and the three-year overall survival rate was 33%, with the Kaplan-Meier curve showing a plateau beyond two years. |
| 2026-05-21 | Agenus Inc. | Results Agenus and Noetik Present ASCO 2026 Data Linking AI Analysis of Routine Pretreatment Tumor Pathology Images to Response and Survival with BOT+BAL in MSS Metastatic CRC agenusbio.com ↗
In a retrospective analysis of refractory MSS metastatic colorectal cancer without active liver metastases, the AI-identified subgroup had a 64% response rate to BOT+BAL, compared with 9% in the remaining cohort |
| 2026-05-21 | Agenus Inc. | Results Agenus Presents Phase 2 BOT+BAL Melanoma Data Showing Durable Responses and Meaningful Survival in Advanced Checkpoint-Refractory Melanoma at ASCO 2026 agenusbio.com ↗
In the overall BOT+BAL population, median overall survival was 16.6 months, 42% of patients were alive at two years, and median duration of response was not reached. |
| 2026-05-15 | Agenus Inc. | Results Agenus Announces Publication of Phase 1b Botensilimab and Balstilimab Data in Post-Immunotherapy Hepatocellular Carcinoma in Liver Cancer agenusbio.com ↗
Among 18 efficacy-evaluable patients, BOT+BAL demonstrated an objective response rate (ORR) of 17%, including one complete response and two partial responses. |
| 2026-04-17 | Agenus Inc. | Results Agenus Reports Phase II Data Demonstrating Immune Reprogramming and Durable Survival with Botensilimab, Balstilimab and agenT-797 in PD-1 Refractory Gastroesophageal Cancer agenusbio.com ↗ |
| 2026-02-19 | Agenus Inc. | Results Agenus Presents Biomarker Data Demonstrating Survival Stratification in MSS mCRC and Other Immunologically Cold Tumors Treated with BOT+BAL agenusbio.com ↗
Integrating blood-based inflammatory markers with tumor immune features improved overall survival stratification in microsatellite-stable metastatic colorectal cancer (MSS mCRC), a population historically resistant to conventional checkpoint inhibitors. |
| 2026-01-12 | Agenus Inc. | Regulatory France Expands National AAC Access for Agenus' Botensilimab + Balstilimab for Ovarian Cancer and Soft-Tissue Sarcomas agenusbio.com ↗
Agenus Inc . ( Nasdaq: AGEN ), a leader in immuno-oncology innovation, today announced that France’s National Agency for Medicines and Health Products Safety (ANSM) has approved an updated national treatment protocol for botensilimab (BOT) plus balst |
| 2025-12-23 | Agenus Inc. | Results Agenus Reports Deep, Durable Responses with Botensilimab + Balstilimab in Highly Refractory Ovarian Cancer, Published in JITC agenusbio.com ↗
In this heavily pretreated population, BOT+BAL demonstrated clinically meaningful activity and durable benefit in women with treatment-refractory ovarian cancer, a population with few remaining options. |
| 2025-10-17 | Agenus Inc. | Results Agenus Reports 39% of Patients Alive at Two-Years with BOT/BAL Across Multiple Refractory Solid Tumors at ESMO 2025 agenusbio.com ↗
“With longer follow up, we’re finding that approximately 40% of patients with very limited survival expectation are alive at two years,” said Michael S. Gordon, MD, HonorHealth Research Institute. |
| 2025-09-09 | Agenus Inc. | Regulatory France Grants Reimbursed Compassionate Access (AAC) for Agenus’ BOT/BAL in Refractory MSS Metastatic Colorectal Cancer agenusbio.com ↗
Agenus Inc. (Nasdaq: AGEN), a leader in immuno‑oncology, today announced its investigational combination botensilimab plus balstilimab (BOT/BAL) is now available to eligible patients with refractory microsatellite‑stable (MSS) metastatic colorectal cancer (mCRC) under France’s compassionate access (Accès compassionnel, or AAC) framework. |
| 2025-07-07 | Agenus Inc. | Results Agenus’ BOT/BAL Achieves 42% Two-Year Survival in Refractory MSS CRC, Advances Toward Registration with FDA Alignment on Phase 3 agenusbio.com ↗
Notably, median overall survival (OS) reached 20.9 months, with 42% of patients still alive at two years in this refractory population. |
| 2025-05-30 | Agenus Inc. | Results Agenus Presents New Data at ASCO Highlighting Botensilimab’s Immune Activation in MSS Colorectal Cancer agenusbio.com ↗
Our findings offer new insight into how patients with immunotherapy-resistant colorectal cancer are responding at the immune level and highlight botensilimab’s potential to activate immune responses in tumors that have historically been unresponsive. |
| 2025-04-28 | Agenus Inc. | Results Agenus’ BOT/BAL Neoadjuvant Pan-Cancer Data from the NEOASIS Study Presented in an Oral Session at AACR agenusbio.com ↗
These initial results from the NEOASIS study indicate that botensilimab and balstilimab can induce pathological responses in patients with a variety of solid tumors, including triple-negative breast cancer, after just two doses, |
| 2025-04-25 | Agenus Inc. | Results Agenus’ BOT/BAL Data in Pretreated Liver Cancer Presented at AACR 2025 agenusbio.com ↗
Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology, today announced updated data from the hepatocellular carcinoma (HCC) cohort of its ongoing Phase 1 study evaluating botensilimab (BOT) in combination with balstilimab (BAL). |
| 2025-02-26 | Agenus Inc. | Results Agenus Reports Impact of Key Immuno-Oncology Data Presented at Leading Medical Conferences and Peer-Reviewed Publications agenusbio.com ↗
The combination targets complementary pathways and has demonstrated clinical responses across nine tumor types, including those historically considered immuno-oncology (IO) "cold" tumors or resistant to prior IO treatments. |
| 2025-02-24 | MiNK Therapeutics | Results MiNK Therapeutics Presents First-in-Kind Allo-iNKTs Combination Data in 2L Gastric Cancer at AACR IO Annual Meeting minktherapeutics.com ↗
The study evaluates agenT-797 in combination with botensilimab and balstilimab (BOT/BAL), in patients with refractory (2L+) gastroesophageal cancer (NCT06251973). |
| 2025-02-24 | Agenus Inc. | Results Agenus Presents New Botensilimab/Balstilimab Data in Gastric Cancer at AACR IO Annual Meeting agenusbio.com ↗
The addition of MiNK’s allogeneic iNKT therapy, agenT-797, to BOT/BAL drove robust immune activation, including elevated interferon-gamma (IFNγ) levels, indicating potent systemic engagement and overcoming immunosuppressive pathways in PD-1–refractory gastric tumors. |
| 2025-01-29 | Agenus Inc. | Results Agenus Announces Publication in the Journal of Clinical Oncology Highlighting Data from Botensilimab Plus Balstilimab in Relapsed/Refractory Metastatic Sarcomas agenusbio.com ↗
These findings highlight the ability of this combination to deliver meaningful clinical benefits, including durable responses and extended survival, for patients who previously had very limited treatment options. |
| 2025-01-22 | Agenus Inc. | Results Agenus Presents Data at ASCO GI Demonstrating Impact of BOT/BAL in Colorectal Cancer Across Neoadjuvant and Advanced Disease agenusbio.com ↗
BOT75/BAL achieved a 19% ORR and 55% disease control rate (DCR) in this refractory population. |
| 2024-09-13 | Agenus Inc. | Results Botensilimab/Balstilimab Clinical Responses in Refractory Sarcomas Presented at ESMO 2024 agenusbio.com ↗
The data from a Phase 1 study of botensilimab (BOT), an investigational Fc-enhanced CTLA-4 inhibitor, in combination with balstilimab (BAL), an investigational PD-1 antibody, showed clinical activity in patients with refractory sarcomas, a population with limited treatment options. |
| 2024-08-07 | Agenus Inc. | Results Agenus Publishes Seminal Study on Botensilimab’s Activity in Treatment-Resistant Cancers agenusbio.com ↗
Botensilimab has shown increased activity in multiple treatment-resistant cancers, including those that have progressed on prior checkpoint inhibitors. |
| 2024-07-18 | Agenus Inc. | Regulatory Agenus Announces End-of-Phase-2 Meeting Outcomes and Topline Interim Phase 2 Data for BOT/BAL in MSS Colorectal Cancer agenusbio.com ↗
FDA advised against submission of these results in support of an Accelerated Approval based on their view that objective response rates may not translate to survival benefit. |
| 2024-06-28 | Agenus Inc. | Results Significant Tumor Reductions in Neoadjuvant MSS Colon Cancer Patients Treated with Botensilimab/Balstilimab Presented at ESMO GI Conference agenusbio.com ↗
In the NEST-2 cohort, 78% (7/9) of MSS patients achieved pathologic responses of at least 50% tumor regression, with 56% (5/9) reaching complete pathologic responses. |
| 2024-06-13 | Agenus Inc. | Results Nature Medicine Reports Agenus’ Novel Immunotherapy Demonstrates Clinical Activity Against a Deadly Form of Colorectal Cancer on the Rise in Americans Under 50 agenusbio.com ↗
Agenus has published results from a groundbreaking clinical trial in Nature Medicine , revealing the potential of a novel immunotherapy combination for treating microsatellite stable metastatic colorectal cancer (MSS mCRC), a cancer type historically resistant to immunotherapy. |
| 2024-05-23 | Agenus Inc. | Results Breakthrough Data on Botensilimab/Balstilimab in MSS CRC Presented at the 2024 ASCO Annual Meeting agenusbio.com ↗
The analysis shows that BOT/BAL is active in metastatic sites beyond the lungs and lymph nodes, including the peritoneum, soft tissue, and brain, which have historically been unresponsive to treatment. |
| 2024-01-22 | Agenus Inc. | Results Botensilimab/Balstilimab Breakthrough Data Presented at ASCO-GI Shows Unprecedented Tumor Shrinkage and Robust Biomarker Response in Prevalent Colorectal Cancer Population agenusbio.com ↗
The study achieved durable elimination of ctDNA, a critical biomarker for cancer clearance and long-term disease-free survival |
| 2023-10-22 | Agenus Inc. | Results Agenus Unveils New and Updated Botensilimab Data in Colorectal, Pancreatic, Lung, Melanoma, and Sarcoma agenusbio.com ↗
“These new and updated data underscore BOT’s broad effectiveness across several advanced solid tumors, demonstrating its potential beyond first-generation immunotherapies and current treatments,” said Dr. Steven O’Day, Chief Medical Officer. |
| 2023-10-21 | Agenus Inc. | Results ESMO 2023: Agenus’ Botensilimab/Balstilimab Combination Delivers Durable Responses across Multiple Sarcoma Subtypes agenusbio.com ↗
As the study has advanced, BOT+BAL continues to demonstrate encouraging results in a larger population of patients with difficult to treat sarcomas, with a median response duration of 19.4 months and a 40% 6-month progression-free survival rate. |
| 2023-06-30 | Agenus Inc. | Results ESMO GI Data: Agenus' Botensilimab/Balstilimab Combination Achieves Unprecedented Survival in Advanced Colorectal Cancer agenusbio.com ↗
The new data show substantial survival benefits and long-lasting responses for patients with non-MSI-H (microsatellite stable or non-microsatellite instability-high) metastatic colorectal cancer previously resistant to chemotherapy and/or immunotherapy. |
| 2023-04-17 | Agenus Inc. | Regulatory Agenus Receives Fast Track Designation for Botensilimab and Balstilimab in Colorectal Cancer agenusbio.com ↗
The designation is for patients with non-microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) metastatic colorectal cancer with no active liver involvement. |
| 2023-03-27 | Agenus Inc. | Results Agenus’ Botensilimab in Combination with Balstilimab Shows 33% Durable Responses in Ovarian Cancer agenusbio.com ↗
These findings, presented in an oral plenary session at the Society of Gynecologic Oncology (SGO) 2023 Annual Meeting on Women’s Cancer, showed a 33% overall response rate (ORR). |
| 2023-01-23 | Agenus Inc. | Results Agenus Presents Clinical Data Demonstrating Durable Responses of Botensilimab/Balstilimab Combination in Metastatic Microsatellite Stable Colorectal Cancer at ASCO GI agenusbio.com ↗
The larger dataset continues to demonstrate that this combination offers superior efficacy and durability compared to what has been reported for standard of care and other investigational therapies in third line metastatic MSS CRC. |
| 2022-11-17 | Agenus Inc. | Results Agenus Data at CTOS 2022 Highlight Durable Clinical Responses of Botensilimab / Balstilimab Combination in Advanced Sarcoma agenusbio.com ↗
Agenus (Nasdaq: AGEN), an immuno-oncology company with a broad pipeline targeting cancer and infectious disease, announced expanded data from the Company’s Phase 1 study of botensilimab (Fc-enhanced anti-CTLA-4) and balstilimab (anti-PD-1) in patients with advanced sarcoma. |
| 2022-11-14 | Agenus Inc. | Results Agenus Data at SITC 2022 Highlight Durable Responses of Botensilimab / Balstilimab Combination in Nine Different Treatment-Resistant Cancers agenusbio.com ↗ |
| 2022-06-29 | Agenus Inc. | Results Agenus Shows Unprecedented Activity for Botensilimab/Balstilimab Combination in Microsatellite Stable Colorectal Cancer at ESMO World GI Congress agenusbio.com ↗
The data demonstrate that the combination offers strong durability and superior efficacy than what has been reported in separate trials for standard of care and other investigational therapies in 2L+ MSS CRC. |
| 2022-03-01 | Agenus Inc. | Results Agenus Corporate Update and Fourth Quarter & Full Year 2021 Financial Report agenusbio.com ↗
Our Phase 1 data presentation at SITC demonstrated the best-in-class potential of our flagship program, botensilimab, consistent with its Fc-enhanced design. |
All press releases naming this drug 59 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited 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 202438“SR-8541A administered orally in combination with intravenous botensilimab and balstilimab” NCT06589440 ↗ “Anti-CTLA-4 antibody botensilimab” NCT06095674 ↗ |
| 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 antibody” NCT03860272 ↗ |
| 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 ↗ |