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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07527858 | Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults With Advanced Colorectal Cancer | PHASE2 | NOT YET_RECRUITING | 170 | — | — | Apr 1, 2026 | Dec 1, 2028 | Apr 14, 2026 | - | — |
ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST Version 1.1.
| Arm | Type | Description |
|---|---|---|
| DEN monotherapy (Arm A) | EXPERIMENTAL | Participants will receive DEN via intravenous (IV) infusion. |
| DEN in combination with NIVO (Arm B) | EXPERIMENTAL | Participants will receive DEN as an IV infusion in combination with NIVO as an IV infusion. |
| DEN in combination with Trifluridine-Tipiracil (FTD-TPI) and BVZ (Arm C) | EXPERIMENTAL | Participants will receive DEN as an IV infusion in combination with BVZ as an IV infusion and FTD-TPI administered orally. Includes a Safety Run-in cohort (non-randomized cohort) prior to randomization. |
| Standard of care (SOC) alone: BVZ and FTD-TPI (Arm D) | ACTIVE_COMPARATOR | Participants will receive BVZ as an IV infusion and FTD-TPI administered orally as SOC. |
| Name | Type | Description |
|---|---|---|
| Denikitug | DRUG | Administered Intravenously |
| Nivolumab | DRUG | Administered Intravenously |
| Bevacizumab | DRUG | Administered Intravenously |
| Trifluridine-Tipiracil | DRUG | Administered orally |
Key Inclusion Criteria: Medical History/Physical Characteristics * Histologically or cytologically confirmed unresectable, recurrent, or locally advanced or metastatic microsatellite stable colorectal cancer (MSS CRC) (adenocarcinoma, excluding appendix cancer). * Documented MSS or proficient mism...