Primary completion· ClinicalTrials.gov
FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metasta
Botensilimab History and Updates
115 events · 2019 – present
Synced daily from openFDA and ClinicalTrials.gov. Last sync: .
0
FDA Approvals
0
Label Revisions
115
Trial Milestones
0
Pivotal Publications
Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-12Download chart as PNG
This page tracks every FDA action, clinical trial milestone, and major publication for Botensilimab since 2019, drawn from openFDA, ClinicalTrials.gov, and PubMed.
All published updates (1)
2026
- Results postedBotensilimab Combination Shows 100% Response in Colorectal Cancer Trial· May 22, 2026
Upcoming & expected milestones
Trial started· ClinicalTrials.gov
BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases
Trial started· ClinicalTrials.gov
Botensilimab, Balstilimab, and SBRT in Colorectal Cancer
Primary completion· ClinicalTrials.gov
The Seven Trial: Exploiting the Unfolded Protein Response
Trial started· ClinicalTrials.gov
A Clinical Study Evaluating a New Treatment Strategy for Patients With Advanced Pancreatic Cancer Who Have Not Received Prior Treatment for
Trial started· ClinicalTrials.gov
Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Ca
Trial started· ClinicalTrials.gov
Testing the Safety and Feasibility of Immunotherapy Drugs, Botensilimab and Balstilimab, Before Surgery for Clear Cell Renal Cell Carcinoma,
Primary completion· ClinicalTrials.gov
Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Ca
Primary completion· ClinicalTrials.gov
Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial
Trial started· ClinicalTrials.gov
Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3
Primary completion· ClinicalTrials.gov
Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases
Primary completion· ClinicalTrials.gov
Botensilimab, Balstilimab, and SBRT in Colorectal Cancer
Primary completion· ClinicalTrials.gov
Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer
Primary completion· ClinicalTrials.gov
Botensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable
Primary completion· ClinicalTrials.gov
Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas
Primary completion· ClinicalTrials.gov
Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer NEST3
Primary completion· ClinicalTrials.gov
A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gast
Primary completion· ClinicalTrials.gov
Testing the Safety and Feasibility of Immunotherapy Drugs, Botensilimab and Balstilimab, Before Surgery for Clear Cell Renal Cell Carcinoma,
Primary completion· ClinicalTrials.gov
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Primary completion· ClinicalTrials.gov
FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery
Primary completion· ClinicalTrials.gov
A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma
Primary completion· ClinicalTrials.gov
A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma
Primary completion· ClinicalTrials.gov
KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Ca
Primary completion· ClinicalTrials.gov
Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas
Primary completion· ClinicalTrials.gov
Botensilimab and Balstilimab Optimization in Colorectal Cancer
Primary completion· ClinicalTrials.gov
BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases
Primary completion· ClinicalTrials.gov
Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma
Primary completion· ClinicalTrials.gov
Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations
Primary completion· ClinicalTrials.gov
A Clinical Study Evaluating a New Treatment Strategy for Patients With Advanced Pancreatic Cancer Who Have Not Received Prior Treatment for
Primary completion· ClinicalTrials.gov
Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMON
Primary completion· ClinicalTrials.gov
The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation
Primary completion· ClinicalTrials.gov
A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy
Primary completion· ClinicalTrials.gov
Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma
Past events
2026
Trial started· ClinicalTrials.gov
Testing the Safety and Feasibility of Immunotherapy Drugs, Botensilimab and Balstilimab, Before Surgery for Clear Cell Renal Cell Carcinoma,
Primary completion· ClinicalTrials.gov
Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma
Primary completion· ClinicalTrials.gov
Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)
Trial started· ClinicalTrials.gov
Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Ca
Results posted· ClinicalTrials.gov
Combination Immunotherapy in Colorectal Cancer
Trial registered· ClinicalTrials.gov
Neoadjuvant Botensilimab and Balstilimab for the Treatment of Advanced Resectable Colorectal Cancer
Trial registered· ClinicalTrials.gov
A Randomized Phase II Study of Priming Treatment With the Hedgehog Inhibitor NLM-001 Prior to Gemcitabine/Nab-Paclitaxel (GNab-P) plusBotens
Primary completion· ClinicalTrials.gov
AGEN1423 and Botensilimab w/ or w/o Chemo in PDAC
Trial registered· ClinicalTrials.gov
Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Ca
Trial registered· ClinicalTrials.gov
BAL/BOT/agenT-797 in pMMR CRC With Liver Metastases
Primary completion· ClinicalTrials.gov
Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis
Trial registered· ClinicalTrials.gov
Testing the Safety and Feasibility of Immunotherapy Drugs, Botensilimab and Balstilimab, Before Surgery for Clear Cell Renal Cell Carcinoma,
Trial started· ClinicalTrials.gov
Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma
Primary completion· ClinicalTrials.gov
A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer
2025
Trial started· ClinicalTrials.gov
Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis
Trial started· ClinicalTrials.gov
Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas
Primary completion· ClinicalTrials.gov
A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer
Primary completion· ClinicalTrials.gov
Combination Immunotherapy in Colorectal Cancer
Trial registered· ClinicalTrials.gov
A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy
Trial started· ClinicalTrials.gov
A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy
Trial registered· ClinicalTrials.gov
Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Colorectal Liver Metastasis
Trial registered· ClinicalTrials.gov
Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma
Trial registered· ClinicalTrials.gov
Botensilimab, Balstilimab, and SBRT in Colorectal Cancer
Trial started· ClinicalTrials.gov
KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Ca
Trial started· ClinicalTrials.gov
The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation
Trial started· ClinicalTrials.gov
FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery
Primary completion· ClinicalTrials.gov
Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Pro
Trial registered· ClinicalTrials.gov
The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation
Trial registered· ClinicalTrials.gov
A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma
Trial started· ClinicalTrials.gov
A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma
Trial registered· ClinicalTrials.gov
FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery
Trial started· ClinicalTrials.gov
Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer
Primary completion· ClinicalTrials.gov
Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer
Trial started· ClinicalTrials.gov
The Seven Trial: Exploiting the Unfolded Protein Response
2024
Trial registered· ClinicalTrials.gov
Expanded Access Program (EAP) Designed to Provide Access to Botensilimab and Balstilimab Before Regulatory Approval
Primary completion· ClinicalTrials.gov
Study of AGEN1571 in Participants With Advanced Solid Tumors
Trial started· ClinicalTrials.gov
Botensilimab and Balstilimab Optimization in Colorectal Cancer
Primary completion· ClinicalTrials.gov
Combination Immunotherapy in Colorectal Cancer
Trial started· ClinicalTrials.gov
Botensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable
Trial registered· ClinicalTrials.gov
Botensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable
Trial started· ClinicalTrials.gov
AGEN1423 and Botensilimab w/ or w/o Chemo in PDAC
Trial started· ClinicalTrials.gov
Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMON
Trial registered· ClinicalTrials.gov
KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Ca
Trial registered· ClinicalTrials.gov
Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas
Trial registered· ClinicalTrials.gov
Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer
Trial started· ClinicalTrials.gov
Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases
Trial registered· ClinicalTrials.gov
Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMON
Trial registered· ClinicalTrials.gov
Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases
Trial registered· ClinicalTrials.gov
Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations
Primary completion· ClinicalTrials.gov
Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer
Trial registered· ClinicalTrials.gov
Botensilimab and Balstilimab Optimization in Colorectal Cancer
Trial registered· ClinicalTrials.gov
A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gast
Trial started· ClinicalTrials.gov
A Study of agenT-797 in Combination With Botensilimab, Balstilimab, Ramucirumab, and Paclitaxel for People With Esophageal, Gastric, or Gast
Trial started· ClinicalTrials.gov
Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma
Trial started· ClinicalTrials.gov
Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations
2023
Trial registered· ClinicalTrials.gov
The Seven Trial: Exploiting the Unfolded Protein Response
Trial started· ClinicalTrials.gov
Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial
Trial registered· ClinicalTrials.gov
Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial
Trial registered· ClinicalTrials.gov
Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma
Trial started· ClinicalTrials.gov
Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)
Trial started· ClinicalTrials.gov
Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Pro
Trial registered· ClinicalTrials.gov
Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)
Trial started· ClinicalTrials.gov
FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metasta
Trial started· ClinicalTrials.gov
A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer
Trial started· ClinicalTrials.gov
Combination Immunotherapy in Colorectal Cancer
Trial registered· ClinicalTrials.gov
Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Pro
2022
Trial started· ClinicalTrials.gov
A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma
Trial registered· ClinicalTrials.gov
AGEN1423 and Botensilimab w/ or w/o Chemo in PDAC
Trial started· ClinicalTrials.gov
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Trial registered· ClinicalTrials.gov
A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer
Trial registered· ClinicalTrials.gov
FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metasta
Trial registered· ClinicalTrials.gov
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Trial registered· ClinicalTrials.gov
Combination Immunotherapy in Colorectal Cancer
Trial registered· ClinicalTrials.gov
A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma
Trial started· ClinicalTrials.gov
Study of AGEN1571 in Participants With Advanced Solid Tumors
Trial registered· ClinicalTrials.gov
Study of AGEN1571 in Participants With Advanced Solid Tumors
2020
Trial started· ClinicalTrials.gov
Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas
2019
Trial registered· ClinicalTrials.gov
Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer
Trial started· ClinicalTrials.gov
Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer
Trial registered· ClinicalTrials.gov
Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas
Trial started· ClinicalTrials.gov
Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer
Trial registered· ClinicalTrials.gov
Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer
Sources
FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.