Floatz Rating
B60/100
Confidence
Indicative
Sponsor
National Cancer Institute (NCI)
Modality
monoclonal_antibody
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
60Moderate confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07551596CT.gov Testing the Combination of Anti-Cancer Drugs, Botensilimab (AGEN1181) and Balstilimab (AGEN2034), After Standard Treatment for Colorectal Cancer, Combat Trial | — | Not Yet Recruiting | — | — | — |
NCT07152821CT.gov Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma | — | Recruiting | — | — | — |
NCT07227636CT.gov A Study of Botensilimab and Balstilimab for Colorectal Cancer With ctDNA+ After Surgery and Chemotherapy | — | Recruiting | — | — | — |
NCT06411691CT.gov KRAS-Targeted Vaccine Combined With Balstilimab and Botensilimab for Patients With Stage IV MMR-p Colorectal Cancer and Pancreatic Ductal Cancer | — | Recruiting | — | — | — |
NCT06336902CT.gov Botensilimab Plus Balstilimab and Fasting Mimicking Diet Plus Vitamin C for Patients With KRAS-Mutant Metastatic Colorectal Cancer | — | Recruiting | — | — | — |
NCT06589440CT.gov Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC) | — | Recruiting | — | — | — |
NCT06268015CT.gov Botensilimab and Balstilimab Optimization in Colorectal Cancer | — | Active Not Recruiting | — | — | — |
NCT06575725CT.gov Botensilimab, Balstilimab and Regorafenib or Botensilimab and Balstilimab for the Treatment of Advanced or Metastatic Microsatellite Stable Colorectal Cancer | — | Withdrawn | — | — | — |
NCT06300463CT.gov Platform Study of Immunotherapy Combinations in Colorectal Cancer Liver Metastases | — | Recruiting | — | — | — |
NCT05845450CT.gov Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN) | — | Recruiting | — | — | — |
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NCT05672316CT.gov Botensilimab, Balstilimab and Regorafenib for the Treatment of Patients With Microsatellite Stable Metastatic Colorectal Cancer Who Have Progressed on Prior Chemotherapy | — | Active Not Recruiting | — | — | — |
NCT05627635CT.gov FOLFOX and Bevacizumab in Combination With Botensilimab and Balstilimab (3B-FOLFOX) for the Treatment of Microsatellite Stable (MSS) Metastatic Colorectal Cancer | — | Active Not Recruiting | — | — | — |
NCT05608044CT.gov A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer | — | Active Not Recruiting | — | — | — |
NCT05205330CT.gov Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers | — | Active Not Recruiting | — | — | — |
NCT03860272CT.gov Fc-Engineered Anti-CTLA-4 Monoclonal Antibody in Advanced Cancer | — | Active Not Recruiting | — | — | — |
NCT06751524CT.gov Expanded Access Program (EAP) Designed to Provide Access to Botensilimab and Balstilimab Before Regulatory Approval | — | Available | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Colorectal Cancer
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Balstilimab (this asset) | National Cancer Institute (NCI) | P3 | B · 60 |
| Desflurane | Peter MacCallum Cancer Centre, Australia | P4 | BBB |
| Marble Dust | James Varani | P2/3 | BB |
| Oxaliplatin | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. | P4 | BB |
| Orectalip | Sinphar Pharmaceutical Co., Ltd | P4 | BB |
| Fluorouracilum | UNICANCER | P4 | BB |
| Levofolinic Acid | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | P3 | BB |
| Fentanyl | Mansoura University | P4 | BB |
| Panitumumab | MSPU des 3 Provinces | P3 | BB |
+42 more in the Colorectal Cancer cohort
Other indications for Balstilimab
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Colorectal Adenocarcinoma | — | P2 | BB · 66 |
| Colon Carcinoma | — | P2 | B · 60 |
| Colorectal Carcinoma | — | P2 | B · 60 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Balstilimab in Colorectal Cancer. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/balstilimab-colorectal-cancer
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