Agenus Inc.
AGENHealthcare|Biotechnology|US
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Clinical Trials (62)
| Trial | Conditions | Phase | Status | Enrollment | Design | Drug |
|---|---|---|---|---|---|---|
| NCT06346197 Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas | Gastric Cancer, MSI-H | P3 | Recruiting | 132 | RCT, Open-label | Balstilimab, Botensilimab, Folfox Protocol, XELOX, Nivolumab |
| NCT06279130 Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations | Resectable MMR-deficient Solid Tumors, Resectable MMR-proficient Solid Tumors | P2P3 | Recruiting | 133 | Open-label | botensilimab, balstilimab, FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel) |
| NCT05632328 AGEN1423 and Botensilimab w/ or w/o Chemo in PDAC | Advanced Pancreatic Ductal Adenocarcinoma, Pancreatic Ductal Adenocarcinoma | P2 | Active | 24 | Open-label | AGEN1423, Botensilimab, Gemcitabine, Nab-paclitaxel |
| NCT07735624 RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS/pMMR Early Rectal Cancer | Early Rectal Cancer, Stage I Rectal Cancer | P2 | Recruiting | 16 | Open-label | Botensilimab, Balstilimab |
| NCT07227636 A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy | Colorectal Cancer, Rectal Cancer | P2 | Recruiting | 284 | RCT, Double-blind | Botensilimab, Balstilimab |
| NCT05608044 A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer | Metastatic Colorectal Cancer | P2 | Active | 234 | RCT, Open-label | Botensilimab, Balstilimab, Standard of Care |
| NCT06782932 Comparing Neoadjuvant/Adjuvant GVAX vs a mKRASvax Given With Anti-PD-1 and Anti-CD137 for Surgically Resectable Pancreatic Cancer | Pancreatic Cancer | P1P2 | Recruiting | 38 | Open-label | AGEN2373, Balstilimab, Cyclophosphamide, GVAX, AGEN2373 (RP2D), Balstilimab, mKRASvax |
| NCT06843434 A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma | Microsatellite Stable Rectal Carcinoma, Locally Advanced Rectal Adenocarcinoma | P2 | Recruiting | 40 | Open-label | Balstilimab, Botensilimab |
| NCT06782555 A Study of Evofosfamide in Combination With Zalifrelimab and Balstilimab | Metastatic Prostate Cancer, Metastatic Head and Neck Squamous Cell Carcinoma | P1P2 | Active | 71 | Open-label | Evofosfamide, Zalifrelimab, Balstilimab |
| NCT05891821 Assessment of the Safety and Efficacy of Balstilimab for the Treatment of Relapsed/Refractory Lymphomas (IMMONC0001) | Lymphoma | P2 | Recruiting | 20 | Open-label | Balstilimab |
| NCT06268015 Botensilimab and Balstilimab Optimization in Colorectal Cancer | Colorectal Cancer | P2 | Active | 16 | Open-label | Botensilimab, Balstilimab, Oxaliplatin, Leucovorin, Fluorouracil, Bevacizumab, Panitumumab |
| NCT04028063 Doxorubicin Plus Dual Checkpoint Blockade for Soft Tissue Sarcomas | Metastatic Soft Tissue Sarcoma, Advanced Soft Tissue Sarcoma | P2 | Active | 65 | Open-label | Balstilimab, Zalifrelimab, Doxorubicin, Botensilimab |
| NCT05864534 Phase 2a Immune Modulation With Ultrasound for Newly Diagnosed Glioblastoma | Newly Diagnosed Glioblastoma, Glioblastoma, Isocitric Dehydrogenase (IDH)-Wildtype | P2 | Active | 25 | Open-label | Balstilimab, Botensilimab, Liposomal Doxorubicin |
| NCT05318469 Ivermectin in Combination With Balstilimab or Pembrolizumab in Patients With Metastatic Triple Negative Breast Cancer and HR+/HER2- Metastatic Breast Cancer | Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma | P1P2 | Recruiting | 34 | Open-label | Ivermectin, Balstilmab, Pembrolizumab |
| NCT04827953 Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer | Pancreatic Ductal Adenocarcinoma | P1P2 | Active | 28 | Open-label | Gemcitabine, Nab paclitaxel, NLM-001, Zalifrelimab |
| NCT06300463 Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases | Colorectal Cancer Metastatic, Liver Metastases | P2 | Recruiting | 24 | RCT, Open-label | Botensilimab, Balstilimab, AGEN1423 |
| NCT06322108 Assessment of the Safety and Efficacy of Balstilimab in Combination With Botensilimab for the Treatment of Non-Small Cell Lung Cancer (IMMONC0008) | Non-small Cell Lung Cancer | P2 | Active | 45 | Open-label | Botensilimab + Balstilimab |
| NCT05205330 Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers | Refractory Metastatic Colorectal Cancer, Solid Tumor | P1P2 | Active | 107 | Open-label | CR6086, AGEN2034 |
| NCT06843551 The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation | Metastatic Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer | P2 | Recruiting | 20 | Open-label | Botensilimab, Balstilimab |
| NCT03860272 Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer | Advanced Cancer, Angiosarcoma | P1 | Active | 499 | Open-label | Botensilimab, Balstilimab |
| NCT06411691 KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer | Colorectal Cancer, Pancreatic Cancer | P1 | Recruiting | 54 | Open-label | KRAS Vaccine with Poly-ICLC adjuvant, Balstilimab, Botensilimab |
| NCT07128355 Botensilimab, Balstilimab, and SBRT in Colorectal Cancer | Non-MSI-H or pMMR Colorectal Cancer With Liver Metastasis | Early P1 | Recruiting | 15 | Open-label | Botensilimab, Balstilimab |
| NCT00033904 Survival Study Of Oncophage® vs. Observation In Patients With Kidney Cancer | Renal Cell Carcinoma | P3 | Completed | 650 | RCT, Open-label | autologous human tumor-derived HSPPC-96 |
| NCT00126178 Clinical Trial Studying a Personalized Cancer Vaccine in Patients With Non-metastatic Kidney Cancer | Kidney Cancer, Renal Cell Carcinoma | P3 | Terminated | 600 | RCT, Open-label | HSPPC-96 |
| NCT07152821 Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma | Colorectal Cancer | P3 | Terminated | 21 | RCT, Open-label | Balstilimab, Botensilimab |
| NCT00039000 Study of Heat Shock Protein-Peptide Complex (HSPPC-96) Versus IL-2/DTIC for Stage IV Melanoma | Malignant Melanoma | P3 | Completed | 350 | RCT, Open-label | HSPPC-96 or Oncophage |
| NCT04943627 Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer (BRAVA) | Advanced Cancer, Metastatic Cervical Cancer | P3 | Withdrawn | — | RCT, Open-label | Balstilimab (BAL), Topotecan, Vinorelbine, Gemcitabine, Irinotecan, Pemetrexed |
| NCT05630183 A Study of Botensilimab in Participants With Metastatic Pancreatic Cancer | Metastatic Pancreatic Ductal Adenocarcinoma | P2 | Completed | 81 | RCT, Open-label | Botensilimab, Gemcitabine, Nab-paclitaxel |
| NCT04607200 AGEN2034 & AGEN1884 in Patients With Recurrent, Inoperable Angiosarcoma | Angiosarcoma | P2 | Withdrawn | — | Open-label | AGEN2034, AGEN1884 |
| NCT00081809 A Safety and Effectiveness Study of Vaccine Therapy in Patients With Indolent Lymphoma | Lymphoma, Follicular, Lymphoma, Small Lymphocytic | P2 | Completed | 35 | Open-label | autologous human tumor-derived HSPPC-96 |
| NCT05571293 Combination Immunotherapy in Colorectal Cancer | Colorectal Neoplasms | P2 | Completed | 26 | Open-label | Botensilimab, Balstilimab |
| NCT03894215 RaPiDS- A Phase 2 Study of Anti-PD-1 Independently or in Combination With Anti-CTLA-4 in Second-Line Cervical Cancer | Cervical Cancer | P2 | Terminated | 211 | RCT, Double-blind | AGEN2034, AGEN1884 |
| NCT05561491 A Study of ONCOS-102 in Combination With Other Novel Immune-therapies in Advanced Treatment-resistant Melanoma Patients | Melanoma | P2 | Withdrawn | — | RCT, Open-label | ONCOS-102, Balstilimab |
| NCT03411473 Study of AGEN1884 With Pembrolizumab in 1L NSCLC | NSCLC Stage IV | P2 | Terminated | 2 | Open-label | AGEN1884 in combination with pembrolizumab |
| NCT00082459 Trial to Compare the Routes of Administration of an Investigational, Personalized, Therapeutic Cancer Vaccine Oncophage (HSPPC-96) in Patients With Metastatic Renal Cell Carcinoma | Renal Cell Carcinoma | P2 | Terminated | 40 | RCT, Open-label | autologous human tumor-derived HSPPC-96 |
| NCT05033132 A Phase II Study of Balstilimab Independently or in Combination With Zalifrelimab in Advanced Cervical Cancer | Cervical Cancer | P2 | Withdrawn | — | RCT, Open-label | Balstilimab, Balstilimab + Zalifrelimab |
| NCT03495882 A Study of Zalifrelimab and Balstilimab for Treatment of Participants With Metastatic or Locally Advanced Solid Tumors, and Expansion Into Select Solid Tumors (Cervical) | Cervical Cancer | P1P2 | Completed | 175 | Open-label | Zalifrelimab, Balstilimab |
| NCT05529316 A Study of Botensilimab (AGEN1181) for the Treatment of Advanced Melanoma | Advanced Melanoma | P2 | Terminated | 150 | RCT, Open-label | Botensilimab, Balstilimab |
| NCT00905060 HSPPC-96 Vaccine With Temozolomide in Patients With Newly Diagnosed GBM | Brain and Central Nervous System Tumors | P2 | Completed | 70 | Open-label | HSPPC-96, Temozolomide |
| NCT00293423 GP96 Heat Shock Protein-Peptide Complex Vaccine in Treating Patients With Recurrent or Progressive Glioma | Brain and Central Nervous System Tumors | P1P2 | Completed | 96 | Open-label | HSPPC-96 |
| NCT00098085 Study of the Feasibility to Derive Vaccine From Tumor Tissue in Patients With Non-Small Cell Lung Cancer | Non-Small-Cell Lung Carcinoma, Lung Cancer | P2 | Completed | 20 | Open-label | HSPPC-96 |
| NCT01687595 Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital Herpes | Herpes Simplex Type 2 | P2 | Completed | 80 | RCT, Double-blind | HerpV and QS-21, Placebo |
| NCT05363709 BALSTILIMAB on Viral Clearance in HPV+ Oropharyngeal Cancer Patients | HPV, Oropharyngeal Cancer | P2 | Withdrawn | — | Open-label | Balstilimab |
| NCT01814813 Vaccine Therapy With Bevacizumab Versus Bevacizumab Alone in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery | Recurrent Glioblastoma, Recurrent Adult Brain Tumor | P2 | Terminated | 90 | RCT, Open-label | HSPPC-96, bevacizumab |
| NCT01147536 Study of Vitespen (HSPPC-96, Oncophage ®) for Immune Response Assessment in Participants With Resectable Renal Cell Carcinoma at Intermediate Risk of Recurrence | Renal Cell Carcinoma | P2 | Terminated | 12 | Open-label | HSPPC-96 |
| NCT02452281 Pilot Study to Evaluate the Effects of a Vaccine (HSPPC-96) Combined With Ipilimumab in Patients With Advanced Melanoma | Melanoma | P1P2 | Withdrawn | — | Open-label | ipilimumab, HSPPC-96 |
| NCT03104699 A Study of AGEN2034 in Advanced Tumors and Cervical Cancer | Advanced Cancer, Cervical Cancer | P1P2 | Completed | 211 | Open-label | AGEN2034 |
| NCT00058747 AG-858 in Patients Who Are Cytogenetically Positive After Treatment With Gleevec™ | Leukemia, Myeloid, Chronic | P2 | Terminated | 40 | Open-label | Autologous HSP-70 Protein-Peptide Complex (AG-858) Plus Gleevec™. |
| NCT05928806 Advanced Renal Cell Cancer Combination ImmunoThErapy Clinical Trial | Advanced Renal Cell Carcinoma | P2 | SUSPENDED | 120 | RCT, Open-label | Botensilimab, Balstilimab, Ipilimumab, Nivolumab |
| NCT02694822 AGEN1884, an Anti-CTLA-4 Human Monoclonal Antibody in Participants With Advanced or Refractory Cancer and Who Have Progressed With PD-1/PD-L1 Inhibitor as Their Most Recent Therapy | Advanced Solid Cancers, Advanced Solid Cancers Refractory to PD-1 and PD-L1 Therapies | P1P2 | Completed | 89 | Open-label | Zalifrelimab |
| NCT04156100 A Study in Subjects With Advanced Solid Tumors | Advanced Solid Tumor | P1 | Terminated | 19 | Open-label | AGEN1223, AGEN1223 and balstilimab |
| NCT06076837 The Seven Trial: Exploiting the Unfolded Protein Response | Pancreatic Cancer Metastatic, Pancreatic Adenocarcinoma Metastatic | P1 | Terminated | 6 | Open-label | Botensilimab, Balstilimab, Chloroquine Phosphate, Celecoxib, Nab paclitaxel, Gemcitabine, Cisplatin |
| NCT00231049 Trial Evaluating Safety, Tolerability and Immune Response of AG-707 | Genital Herpes | P1 | Completed | 35 | RCT, Single-blind | AG-707 |
| NCT05377528 Study of AGEN1571 in Participants With Advanced Solid Tumors | Advanced Solid Tumor | P1 | Completed | 22 | Open-label | AGEN1571, Balstilimab, Botensilimab |
| NCT06095674 ImmunoTHerapy Adjacent to Cervical CAncer (ITHACA) Study | Cervical Cancer | P1 | Unknown | 30 | Open-label | Anti-PD-1 antibody balstilimab |
| NCT03673020 Phase 1a Study to Evaluate Immunogenicity of ASV® | Solid Tumor, Adult | P1 | Completed | 3 | Open-label | ASV® AGEN2017 + QS-21 Stimulon® adjuvant |
| NCT02992977 Safety and Tolerability Study of AutoSynVax™ Vaccine in Subjects With Advanced Cancer | Advanced Cancer | P1 | Terminated | 3 | Open-label | AutoSynVax™ vaccine |
| NCT04121676 Anti-CD137 and Anti-CTLA-4 Monoclonal Antibody in Patients With Advanced Cancer | Advanced Cancer | P1 | Completed | 91 | Open-label | AGEN2373, Botensilimab |
| NCT05025085 A Study Investigating AGEN1777 in Participants With Advanced Solid Tumors | Advanced Cancer | P1 | Completed | 25 | RCT, Open-label | AGEN1777, a PD-1 inhibitor |
| NCT00316511 Study of L-NDDP (Aroplatin) in Patients With Advanced Solid Malignancies or B-Cell Lymphoma | Malignancies, B-Cell Lymphoma | P1 | Completed | 21 | Open-label | Aroplatin |
| NCT06751524 Expanded Access Program (EAP) Designed to Provide Access to Botensilimab and Balstilimab Before Regulatory Approval | Colorectal Cancer (CRC), Pancreatic Cancer | AVAILABLE | — | — | Botensilimab, Balstililmab | |
| NCT05572970 Expanded Access for Cancer Treatment With Balstilimab (AGEN2034) and Zalifrelimab (AGEN1884) | Cancer | AVAILABLE | — | — | Balstilimab, Zalifrelimab |