MedPath

Botensilimab

Generic Name
Botensilimab
Drug Type
Biotech
CAS Number
2408310-37-0
Unique Ingredient Identifier
1Z5YC3ME5N
Background

Botensilimab is under investigation in clinical trial NCT03860272 (Fc-engineered Anti-ctla-4 Monoclonal Antibody in Advanced Cancer).

A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma

Phase 2
Recruiting
Conditions
Microsatellite Stable Rectal Carcinoma
Locally Advanced Rectal Adenocarcinoma
Interventions
First Posted Date
2025-02-25
Last Posted Date
2025-03-18
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
40
Registration Number
NCT06843434
Locations
🇺🇸

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown, New Jersey, United States

🇺🇸

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey, United States

and more 4 locations

The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation

Phase 2
Not yet recruiting
Conditions
Metastatic Pancreatic Ductal Adenocarcinoma
Metastatic Pancreatic Cancer
Interventions
Radiation: Stereotactic Body Radiation Therapy
First Posted Date
2025-02-25
Last Posted Date
2025-02-25
Lead Sponsor
Benjamin Spieler
Target Recruit Count
20
Registration Number
NCT06843551
Locations
🇺🇸

University of Miami, Miami, Florida, United States

FOLFOX, Botensilimab, and Balstilimab for the Treatment of Localized Rectal Cancer Before Surgery

Phase 2
Not yet recruiting
Conditions
Rectal Adenocarcinoma
Stage IIA Rectal Cancer AJCC v8
Stage III Rectal Cancer AJCC v8
Interventions
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Digital Rectal Examination
Procedure: Endoscopic Biopsy
Procedure: Magnetic Resonance Imaging
Radiation: Radiation Therapy
Procedure: Sigmoidoscopy
First Posted Date
2025-01-17
Last Posted Date
2025-01-17
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
26
Registration Number
NCT06780787
Locations
🇺🇸

City of Hope Medical Center, Duarte, California, United States

Expanded Access Program (EAP) Designed to Provide Access to Botensilimab and Balstilimab Before Regulatory Approval

Conditions
Colorectal Cancer (CRC)
Pancreatic Cancer
Non-Small Cell Lung Cancer (NSCLC)
Hepatocellular Carcinoma (HCC)
Melanoma
Sarcoma
Ovarian Cancer
Prostate Cancer
First Posted Date
2024-12-30
Last Posted Date
2024-12-30
Lead Sponsor
Agenus Inc.
Registration Number
NCT06751524

Botensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable Colorectal Cancer

Phase 2
Withdrawn
Conditions
Stage IV Colorectal Cancer AJCC v8
Advanced Colon Adenocarcinoma
Stage IV Colon Cancer AJCC v8
Advanced Colorectal Adenocarcinoma
Metastatic Colorectal Adenocarcinoma
Advanced Rectal Adenocarcinoma
Metastatic Colon Adenocarcinoma
Stage III Colon Cancer AJCC v8
Stage IV Rectal Cancer AJCC v8
Metastatic Rectal Adenocarcinoma
Interventions
Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
First Posted Date
2024-08-28
Last Posted Date
2024-11-21
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
84
Registration Number
NCT06575725
Locations
🇺🇸

City of Hope Medical Center, Duarte, California, United States

KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer

Phase 1
Recruiting
Conditions
Pancreatic Cancer
Colorectal Cancer
Interventions
Drug: KRAS Vaccine with Poly-ICLC adjuvant
First Posted Date
2024-05-13
Last Posted Date
2025-04-06
Lead Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Target Recruit Count
54
Registration Number
NCT06411691
Locations
🇺🇸

Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas

Phase 3
Not yet recruiting
Conditions
Gastric Cancer
MSI-H
Metastatic Cancer
Advanced Cancer
Interventions
First Posted Date
2024-04-03
Last Posted Date
2024-08-23
Lead Sponsor
Centre Leon Berard
Target Recruit Count
124
Registration Number
NCT06346197
Locations
🇫🇷

Centre Léon Bérard, Lyon, France

Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients with KRAS-Mutant Metastatic Colorectal Cancer

Phase 1
Recruiting
Conditions
Metastatic Colorectal Adenocarcinoma
Stage IV Colorectal Cancer AJCC V8
Interventions
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Other: Dietary Intervention
Procedure: Magnetic Resonance Imaging
Dietary Supplement: Vitamin C
First Posted Date
2024-03-29
Last Posted Date
2025-02-03
Lead Sponsor
University of Southern California
Target Recruit Count
15
Registration Number
NCT06336902
Locations
🇺🇸

Los Angeles General Medical Center, Los Angeles, California, United States

🇺🇸

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008)

Phase 2
Recruiting
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2024-03-20
Last Posted Date
2025-05-08
Lead Sponsor
Immune Oncology Research Institute
Target Recruit Count
45
Registration Number
NCT06322108
Locations
🇦🇲

Hematology Center named after prof. R. Yeolyan, Yerevan, Armenia

Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases

Phase 2
Recruiting
Conditions
Liver Metastases
Colorectal Cancer
Colorectal Cancer Metastatic
Interventions
First Posted Date
2024-03-08
Last Posted Date
2025-04-06
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
24
Registration Number
NCT06300463
Locations
🇺🇸

Weill Cornell Medicine/NewYork-Presbyterian Hospital, New York, New York, United States

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