Drugs / Balstilimab
Trials 55 · a red edge is where a trial was stopped
| 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 111 trials | ||||||
| Phase 1 | NCT07695311 | Oct 2026 → Oct 2029 expected | Ewing sarcoma, desmoplastic small round cell tumor | Rabi Hanna | Not yet recruiting | No outcome recorded |
| 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 | NCT05930951 | Nov 2023 → Oct 2024 | adenoid cystic carcinoma | Groupe Oncologie Radiotherapie Tete et Cou | Terminated | No outcome recorded |
| Phase 1 | NCT06063681 | Oct 2023 → Dec 2025 overdue | metastatic neoplasm | Stingray Therapeutics | Recruiting | No outcome recorded |
| Phase 1 | NCT05377528 | Jul 2022 → Dec 2024 | neoplasm | Agenus Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04943848 | Jan 2022 → Sep 2026 expected | diffuse midline glioma, H3 K27M-mutant | Ann & Robert H Lurie Children's Hospital of Chicago | Recruiting | No outcome recorded |
| Phase 1 | NCT04156100 | Dec 2019 → Apr 2021 | neoplasm | Agenus Inc. | Terminated | 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 1/27 trials | ||||||
| Phase 1/2 | NCT06782555 | Jan 2025 → Oct 2027 expected | head and neck squamous cell carcinoma, malignant pancreatic neoplasm, metastatic prostate carcinoma | ImmunoGenesis | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05318469 | Oct 2023 → Oct 2026 expected | triple-negative breast carcinoma | Yuan Yuan | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05672316 | May 2023 → May 2025 overdue | colorectal adenocarcinoma | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05627635 | May 2023 → Jun 2026 overdue | colon adenocarcinoma, rectum adenocarcinoma | City of Hope Medical Center | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05205330 | Nov 2021 → Dec 2026 expected | colorectal cancer, gastric cancer | Rottapharm Biotech | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT03495882 | Dec 2017 → Jul 2022 | cervical cancer | Agenus Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT03104699 | Apr 2017 → Jun 2022 | cancer of unknown primary site, cervical cancer | Agenus Inc. | Completed | No outcome recorded |
| Phase 230 trials | ||||||
| Phase 2 | NCT07595874 | Dec 2026 → May 2027 expected | colon adenocarcinoma, rectum adenocarcinoma | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07516366 | Aug 2026 → Aug 2027 expected | clear cell renal carcinoma | National Cancer Institute (NCI) | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07551596 | Aug → Sep 2026 expected | colorectal adenocarcinoma | National Cancer Institute (NCI) | Not yet 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 | 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 | Recruiting | No outcome recorded |
| Phase 2 | NCT05561491 | Jan 2024 → Jun 2027 | cutaneous melanoma | Targovax Oy | Withdrawn | No outcome recorded |
| Phase 2 | NCT05363709 | Oct 2023 → May 2026 | human papilloma virus infection, oropharynx cancer | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 2 | NCT05928806 | Sep 2023 → Nov 2026 | renal cell carcinoma | Michael B. Atkins, MD | Suspended | No outcome recorded |
| Phase 2 | NCT05891821 | Sep 2023 → Sep 2029 expected | lymphoma | Immune Oncology Research Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT05845450 | May 2023 → May 2026 overdue | colorectal carcinoma | Gruppo Oncologico del Nord-Ovest | Recruiting | No outcome recorded |
| Phase 2 | NCT05571293 | Mar 2023 → Nov 2024 overdue | colorectal neoplasm | Weill Medical College of Cornell University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05638698 | Dec 2022 → Dec 2024 overdue | neoplasm | University of Kansas Medical Center | Active not recruiting | 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 | NCT05033132 | Oct 2021 → Dec 2024 | cervical cancer | Agenus Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT04607200 | Feb → Sep 2021 | angiosarcoma | Agenus Inc. | Withdrawn | No outcome recorded |
| Phase 2 | NCT04430036 | Oct 2020 → Oct 2021 | urinary bladder cancer | The University of Texas Health Science Center at San Antonio | Terminated | 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 | NCT03894215 | Jun 2019 → Mar 2025 | cervical cancer | Agenus Inc. | Terminated | 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 33 trials | ||||||
| Phase 3 | NCT07152821 | Mar → Jul 2026 | colorectal cancer | Canadian Cancer Trials Group | Terminated | No outcome recorded |
| Phase 3 | NCT06346197 | Dec 2025 → May 2028 expected | gastric cancer, metastatic malignant neoplasm | Centre Leon Berard | Recruiting | No outcome recorded |
| Phase 3 | NCT04943627 | Aug → Oct 2021 | cancer of unknown primary site, cervical cancer | Agenus Inc. | Withdrawn | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT05572970 | — | cancer | Agenus Inc. | Available | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06782932 Background | May 2025 → Dec 2028 expected | pancreatic adenocarcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06751524 Background | — | colorectal cancer, hepatocellular carcinoma, malignant pancreatic neoplasm, melanoma +4 | Agenus Inc. | Available | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 58 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | balstilimab | “AGEN2034 (balstilimab) is a novel, fully human monoclonal immunoglobulin G4 antibody, designed to block programmed cell death 1 (PD-1) from interacting with its ligands (PD-L)...” NCT05205330 ↗50“SR-8541A administered orally in combination with intravenous botensilimab and balstilimab” NCT06589440 ↗ “Administered via an IV infusion of Botensilimab + Balstilimab combination (BOT+BAL).” NCT06751524 ↗ “Balstilimab 300 mg administered intravenously on Day 1 of each 21 day cycle.” NCT05318469 ↗ “Balstilimab: 240 mg IV Day 1 and Day 15 of each 28-day cycle.” NCT07578337 ↗ |
| Known as | AGEN2034 | “Expanded Access for Cancer Treatment With Balstilimab (AGEN2034) and Zalifrelimab (AGEN1884)” NCT05572970 ↗ |
| Known as | BAL | “Balstilimab (BAL)” NCT04943627 ↗ |
| Known as | SR-8541A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06589440 ↗ |
| Action | Inhibit | “balstilimab (BAL; anti-PD-1 antibody)” PMID 38871975 ↗ Jun 2024 |
| Modality | Monoclonal antibody | “Anti-programmed cell death protein-1 (PD-1) Monoclonal Antibody” NCT03104699 ↗ |
| Route | Intravenous | “intravenous (IV)” NCT03104699 ↗ |
| Target | PDCD1 | “Balstilimab (AGEN2034) is a human monoclonal antibody that targets programmed cell death 1 (PD-1).” NCT04028063 ↗ |