Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05608044 | A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 234 | — | — | Nov 30, 2022 | Sep 1, 2029 | Sep 4, 2025 | 65 | United States, Belgium +6 |
Objective response rate is defined as the proportion of participants with complete response or partial response, as assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
| Arm | Type | Description |
|---|---|---|
| Combination Botensilimab Dose 1 plus Balstilimab | EXPERIMENTAL | Participants will receive botensilimab at dose 1 given IV and balstilimab given IV. |
| Combination Botensilimab Dose 2 plus Balstilimab | EXPERIMENTAL | Participants will receive botensilimab at dose 2 given IV and balstilimab given IV. |
| Monotherapy Botensilimab Dose 1 | EXPERIMENTAL | Participants will receive botensilimab dose 1 given IV. |
| Monotherapy Botensilimab Dose 2 | EXPERIMENTAL | Participants will receive botensilimab dose 2 given IV. |
| Standard of Care | ACTIVE_COMPARATOR | Participants will receive select standard of care as determined by the investigator. |
| Name | Type | Description |
|---|---|---|
| Botensilimab | DRUG | An anti-cytotoxic T-lymphocyte antigen 4 (CTLA-4) monoclonal antibody. |
| Balstilimab | DRUG | An anti-programmed death (ligand) 1 \[PD-(L)1\] monoclonal antibody. |
| Standard of Care | DRUG | Regorafenib or trifluridine and tipiracil. |
Inclusion Criteria: 1. Histologically confirmed diagnosis of unresectable and metastatic CRC adenocarcinoma. 2. The tumor must have been assessed for microsatellite instability high (MSI-H) or deficient mismatch repair (dMMR) status per a standard local testing method. 3. Voluntarily agree to parti...