Botensilimab Clinical Trials (2026): 33 Studies for Colorectal Cancer & Stage IV Colorectal Cancer AJCC v8
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
33 Botensilimab clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 26 indications (including Colorectal Cancer & Stage IV Colorectal Cancer AJCC v8) and 2,459 total planned enrollment. 2 Phase 3 Botensilimab trials and 19 Phase 2 are listed. 14 Botensilimab clinical trials are actively recruiting at 25 U.S. sites across 7 states. Most recent activity: NCT06279130 (Jan 2034).
Where to Participate: All Botensilimab Trial Sites in the U.S. (25 sites across 7 states)
Every actively recruiting Botensilimabtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| CA | City of Hope Medical Center | Duarte91010 | NCT06780787 | Map |
| CA | Saint Jude Medical Center / Providence Medical Foundation | Fullerton92835 | NCT06336902 | Map |
| CA | Los Angeles General Medical Center | Los Angeles90033 | NCT06336902 | Map |
| CA | USC / Norris Comprehensive Cancer Center | Los Angeles90033 | NCT06336902 | Map |
| FL | University of Miami | Miami33136 | NCT06843551 | Map |
| IL | Northwestern University | Chicago60611 | NCT05864534 | Map |
| MD | Sidney Kimmel Comprehensive Cancer Center | Baltimore21231 | NCT06411691 | Map |
| MA | Massachusetts General Hospital | Boston02114 | NCT07128355 | Map |
| NJ | Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge07920 | NCT06843434 | Map |
| NJ | Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge07920 | NCT07227636 | Map |
| NJ | Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Middletown07748 | NCT06843434 | Map |
| NJ | Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Middletown07748 | NCT07227636 | Map |
| NJ | Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale07645 | NCT06843434 | Map |
| NJ | Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale07645 | NCT07227636 | Map |
| NY | Memorial Sloan Kettering Cancer Center at Suffolk - Commack (Limited Protocol Activities) | Commack11725 | NCT06843434 | Map |
| NY | Memorial Sloan Kettering Commack (Limited Protocol Activities) | Commack11725 | NCT07227636 | Map |
| NY | Memorial Sloan Kettering Westchester (All Protocol Activities) | Harrison10604 | NCT07227636 | Map |
| NY | Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison10604 | NCT06843434 | Map |
| NY | RJ Zuckerberg | Lake Success11042 | NCT07193862 | Map |
| NY | Long Island Jewish Medical Center | New Hyde Park11040 | NCT07193862 | Map |
| NY | Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York10065 | NCT06843434 | Map |
| NY | Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York10065 | NCT07227636 | Map |
| NY | Weill Cornell Medicine/NewYork-Presbyterian Hospital | New York10065 | NCT06300463 | Map |
| NY | Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Rockville Centre11553 | NCT07227636 | Map |
| NY | Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Uniondale11553 | NCT06843434 | Map |
Botensilimab clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | terminated | withdrawn | suspended | not yet recruiting | available | Total |
|---|---|---|---|---|---|---|---|---|---|
| Early P1 | 2 | 2 | |||||||
| P1 | 2 | 1 | 2 | 1 | 6 | ||||
| P1/P2 | 2 | 2 | |||||||
| P2 | 7 | 8 | 1 | 1 | 1 | 1 | 19 | ||
| P2/P3 | 1 | 1 | |||||||
| P3 | 1 | 1 | 2 | ||||||
| N/A | 1 | 1 |
Recruiting Botensilimab clinical trials (14)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT06279130 | NEOASISPan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations | P2/P3 | Resectable MMR-deficient Solid Tumors | 133 | Jan 2024 |
| NCT05864534 | Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma | P2 | Newly Diagnosed Glioblastoma | 25 | Jan 2024 |
| NCT07227636 | A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy | P2 | Colorectal Cancer | 284 | Nov 2025 |
| NCT06843551 | EMPIREThe Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation | P2 | Metastatic Pancreatic Ductal Adenocarcinoma | 20 | Jun 2025 |
| NCT06411691 | KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer | P1 | Colorectal Cancer | 54 | Jun 2025 |
| NCT05845450 | UNICORNPre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) | P2 | Colorectal Cancer | 197 | May 2023 |
| NCT06346197 | CIMECombination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas | P3 | Gastric Cancer | 132 | Dec 2025 |
| NCT07193862 | Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis | Early P1 | Colorectal Cancer Metastatic | 10 | Dec 2025 |
| NCT06843434 | A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma | P2 | Microsatellite Stable Rectal Carcinoma | 40 | Feb 2025 |
| NCT06336902 | Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer | P1 | Metastatic Colorectal Adenocarcinoma | 15 | Jan 2025 |
| NCT06300463 | Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases | P2 | Colorectal Cancer Metastatic | 24 | Mar 2024 |
| NCT06780787 | FOLFOXFOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery | P2 | Rectal Adenocarcinoma | 26 | May 2025 |
| NCT07128355 | Botensilimab, Balstilimab, and SBRT in Colorectal Cancer | Early P1 | Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis | 15 | May 2026 |
| NCT07516366 | Testing the Safety and Feasibility of Immunotherapy Drugs, Botensilimab and Balstilimab, Before Surgery for Clear Cell Renal Cell Carcinoma, NEO RoBOT Trial | P2 | Clear Cell Renal Cell Carcinoma | 16 | Aug 2026 |
Botensilimab clinical trials by indication
Colorectal Cancer (5)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07227636 | — | P2 | recruiting | A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy |
| NCT06411691 | — | P1 | recruiting | KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer |
| NCT06268015 | BBOpCo | P2 | active not recruiting | Botensilimab and Balstilimab Optimization in Colorectal Cancer |
| NCT05845450 | UNICORN | P2 | recruiting | Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) |
| NCT07152821 | BATTMAN | P3 | terminated | Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma |
Colorectal Cancer Metastatic (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07193862 | — | Early P1 | recruiting | Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis |
| NCT06300463 | — | P2 | recruiting | Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases |
Metastatic Pancreatic Ductal Adenocarcinoma (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06843551 | EMPIRE | P2 | recruiting | The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation |
| NCT05630183 | — | P2 | completed | A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer |
Advanced Cancer (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03860272 | — | P1 | active not recruiting | Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer |
| NCT04121676 | — | P1 | completed | Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer |
Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07128355 | — | Early P1 | recruiting | Botensilimab, Balstilimab, and SBRT in Colorectal Cancer |
Clear Cell Renal Cell Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07516366 | — | P2 | not yet recruiting | Testing the Safety and Feasibility of Immunotherapy Drugs, Botensilimab and Balstilimab, Before Surgery for Clear Cell Renal Cell Carcinoma, NEO RoBOT Trial |
Gastric Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06346197 | CIME | P3 | recruiting | Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas |
Rectal Adenocarcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06780787 | FOLFOX | P2 | recruiting | FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery |
Microsatellite Stable Rectal Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06843434 | — | P2 | recruiting | A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma |
Metastatic Colorectal Adenocarcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06336902 | — | P1 | recruiting | Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer |
Pancreatic Cancer Metastatic (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06076837 | — | P1 | terminated | The Seven Trial: Exploiting the Unfolded Protein Response |
Advanced Colon Adenocarcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06575725 | — | P2 | withdrawn | Botensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable Colorectal Cancer |
Advanced Pancreatic Ductal Adenocarcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05632328 | — | P2 | active not recruiting | AGEN1423 and Botensilimab w/ or w/o Chemo in PDAC |
Non-small Cell Lung Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06322108 | IMMONC0008 | P2 | active not recruiting | Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008) |
Metastatic Esophageal Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06251973 | — | P2 | active not recruiting | A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer |
Newly Diagnosed Glioblastoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05864534 | — | P2 | recruiting | Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma |
Resectable MMR-deficient Solid Tumors (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06279130 | NEOASIS | P2/P3 | recruiting | Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations |
Advanced Renal Cell Carcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05928806 | ARCITECT | P2 | suspended | Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial |
Advanced Colorectal Adenocarcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05672316 | — | P1/P2 | active not recruiting | Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy |
Metastatic Colon Adenocarcinoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05627635 | MSS | P1/P2 | active not recruiting | FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer |
Colorectal Neoplasms (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05571293 | NEST-1 | P2 | active not recruiting | Combination Immunotherapy in Colorectal Cancer |
Advanced Melanoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05529316 | AGEN1181 | P2 | active not recruiting | A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma |
Metastatic Colorectal Cancer (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05608044 | — | P2 | active not recruiting | A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer |
Advanced Solid Tumor (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05377528 | — | P1 | completed | Study of AGEN1571 in Participants With Advanced Solid Tumors |
Metastatic Soft Tissue Sarcoma (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04028063 | — | P2 | active not recruiting | Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas |
Colorectal Cancer (CRC) (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT06751524 | EAP | N/A | available | Expanded Access Program (EAP) Designed to Provide Access to Botensilimab and Balstilimab Before Regulatory Approval |
Botensilimab pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| CIME | NCT06346197 | P3 | recruiting | Gastric Cancer | 132 | — |
| BATTMAN | NCT07152821 | P3 | terminated | Colorectal Cancer | 21 | — |
| EMPIRE | NCT06843551 | P2 | recruiting | Metastatic Pancreatic Ductal Adenocarcinoma | 20 | — |
| IMMONC0008 | NCT06322108 | P2 | active not recruiting | Non-small Cell Lung Cancer | 45 | — |
| BBOpCo | NCT06268015 | P2 | active not recruiting | Colorectal Cancer | 16 | — |
| UNICORN | NCT05845450 | P2 | recruiting | Colorectal Cancer | 197 | — |
| AGEN1181 | NCT05529316 | P2 | active not recruiting | Advanced Melanoma | 150 | — |
| ARCITECT | NCT05928806 | P2 | suspended | Advanced Renal Cell Carcinoma | 120 | — |
| FOLFOX | NCT06780787 | P2 | recruiting | Rectal Adenocarcinoma | 26 | — |
| NEST-1 | NCT05571293 | P2 | active not recruiting | Colorectal Neoplasms | 26 | — |
Terminated and withdrawn Botensilimab trials (4)
Studies that ended before completion. Reasons are filed in each trial's ClinicalTrials.gov entry.
- NCT05928806suspendedAdvanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial
- NCT06575725withdrawnBotensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable Colorectal Cancer
- NCT07152821terminatedBotensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma
- NCT06076837terminatedThe Seven Trial: Exploiting the Unfolded Protein Response
All Botensilimab trials (33)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT06279130 | NEOASIS | Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations | P2/P3 | recruiting | 133 | The Netherlands Cancer Institute | Jan 2024 |
| NCT05864534 | Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma | P2 | recruiting | 25 | Northwestern University | Jan 2024 | |
| NCT07227636 | A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy | P2 | recruiting | 284 | Memorial Sloan Kettering Cancer Center | Nov 2025 | |
| NCT06843551 | EMPIRE | The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation | P2 | recruiting | 20 | Benjamin Spieler | Jun 2025 |
| NCT06322108 | IMMONC0008 | Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008) | P2 | active not recruiting | 45 | Immune Oncology Research Institute | Jun 2024 |
| NCT05608044 | A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer | P2 | active not recruiting | 234 | Agenus Inc. | Nov 2022 | |
| NCT06411691 | KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer | P1 | recruiting | 54 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Jun 2025 | |
| NCT06268015 | BBOpCo | Botensilimab and Balstilimab Optimization in Colorectal Cancer | P2 | active not recruiting | 16 | Nicholas DeVito, MD | Nov 2024 |
| NCT05845450 | UNICORN | Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) | P2 | recruiting | 197 | Gruppo Oncologico del Nord-Ovest | May 2023 |
| NCT06346197 | CIME | Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas | P3 | recruiting | 132 | Centre Leon Berard | Dec 2025 |
| NCT07193862 | Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis | Early P1 | recruiting | 10 | Northwell Health | Dec 2025 | |
| NCT05529316 | AGEN1181 | A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma | P2 | active not recruiting | 150 | Agenus Inc. | Dec 2022 |
| NCT06843434 | A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma | P2 | recruiting | 40 | Memorial Sloan Kettering Cancer Center | Feb 2025 | |
| NCT06336902 | Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer | P1 | recruiting | 15 | University of Southern California | Jan 2025 | |
| NCT06300463 | Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases | P2 | recruiting | 24 | Weill Medical College of Cornell University | Mar 2024 | |
| NCT04028063 | Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas | P2 | active not recruiting | 65 | University of Colorado, Denver | Jan 2020 | |
| NCT03860272 | Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer | P1 | active not recruiting | 499 | Agenus Inc. | Mar 2019 | |
| NCT05928806 | ARCITECT | Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial | P2 | suspended | 120 | Michael B. Atkins, MD | Sep 2023 |
| NCT06780787 | FOLFOX | FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery | P2 | recruiting | 26 | City of Hope Medical Center | May 2025 |
| NCT07128355 | Botensilimab, Balstilimab, and SBRT in Colorectal Cancer | Early P1 | recruiting | 15 | Massachusetts General Hospital | May 2026 | |
| NCT07516366 | Testing the Safety and Feasibility of Immunotherapy Drugs, Botensilimab and Balstilimab, Before Surgery for Clear Cell Renal Cell Carcinoma, NEO RoBOT Trial | P2 | not yet recruiting | 16 | National Cancer Institute (NCI) | Aug 2026 | |
| NCT06251973 | A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gastro-esophageal Junction Cancer | P2 | active not recruiting | 20 | Memorial Sloan Kettering Cancer Center | Feb 2024 | |
| NCT05632328 | AGEN1423 and Botensilimab w/ or w/o Chemo in PDAC | P2 | active not recruiting | 24 | Bruno Bockorny | Aug 2024 | |
| NCT06575725 | Botensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable Colorectal Cancer | P2 | withdrawn | 0 | City of Hope Medical Center | Nov 2024 | |
| NCT05672316 | Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy | P1/P2 | active not recruiting | 28 | City of Hope Medical Center | May 2023 | |
| NCT05571293 | NEST-1 | Combination Immunotherapy in Colorectal Cancer | P2 | active not recruiting | 26 | Weill Medical College of Cornell University | Mar 2023 |
| NCT07152821 | BATTMAN | Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma | P3 | terminated | 21 | Canadian Cancer Trials Group | Mar 2026 |
| NCT05627635 | MSS | FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer | P1/P2 | active not recruiting | 20 | City of Hope Medical Center | May 2023 |
| NCT05630183 | A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer | P2 | completed | 81 | Agenus Inc. | Mar 2023 | |
| NCT06076837 | The Seven Trial: Exploiting the Unfolded Protein Response | P1 | terminated | 6 | HonorHealth Research Institute | Jan 2025 | |
| NCT06751524 | EAP | Expanded Access Program (EAP) Designed to Provide Access to Botensilimab and Balstilimab Before Regulatory Approval | — | available | 0 | Agenus Inc. | — |
| NCT05377528 | Study of AGEN1571 in Participants With Advanced Solid Tumors | P1 | completed | 22 | Agenus Inc. | Jul 2022 | |
| NCT04121676 | Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer | P1 | completed | 91 | Agenus Inc. | Sep 2019 |
Botensilimab clinical trials: frequently asked questions
- How many Botensilimab clinical trials are there?
- 33 Botensilimab clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 13 are actively recruiting participants. 3 are marked completed.
- Are Botensilimab clinical trials recruiting in 2026?
- Yes — 13 Botensilimab trials are actively recruiting in 2026, with 25 U.S. sites across 7 states. See the recruiting trials and the per-state site list further down this page.
- What conditions is Botensilimab being studied for?
- Botensilimab is being studied for Colorectal Cancer, Stage IV Colorectal Cancer AJCC v8, Metastatic Colorectal Adenocarcinoma, Pancreatic Cancer, Advanced Cancer and 73 more. The trials are grouped by indication on this page.
- What phase is Botensilimab in?
- Botensilimab clinical trials span 2 Phase 3, 19 Phase 2, 6 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Botensilimab clinical trials?
- The lead sponsor across the most Botensilimab trials is Agenus Inc., with 20 additional lead sponsors listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Botensilimabas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
Last refreshed .
Related pages on Hipa.ai: