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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05205330 | Vorbipiprant (CR6086) / Balstilimab (AGEN2034) Combination in Stage IV Refractory pMMR - MSS CRC, and Other Metastatic GI Cancers | PHASE1 | ACTIVE NOT_RECRUITING | 107 | — | — | Nov 23, 2021 | Jun 1, 2027 | Oct 29, 2025 | 3 | Italy |
Incidence of TEAEs using NCI CTCAE v5.0
Proportion of patients who have achieved CR, PR, or stable disease (SD) per RECIST 1.1 / iRECIST during the Dose Escalation part
Proportion of patients who have achieved CR or PR per RECIST 1.1 / iRECIST during the Expansion part (Phase IIa)
| Arm | Type | Description |
|---|---|---|
| 30 mg (Dose Level 1) | EXPERIMENTAL | 14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 30 mg twice a day for 14 days |
| 90 mg (Dose Level 2) | EXPERIMENTAL | 14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 90 mg twice a day for 14 days |
| 180 mg (Dose Level 3) | EXPERIMENTAL | 14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 180 mg twice a day for 14 days |
| other mGI cancers | EXPERIMENTAL | 14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 90 mg twice a day for 14 days |
| Expansion in MSS/pMMR mCRC patients | EXPERIMENTAL | 14-day cycles of combined AGEN2034 3 mg/Kg iv on D1 of each cycle, and oral CR6086 90 mg twice a day for 14 days |
| Name | Type | Description |
|---|---|---|
| CR6086 | DRUG | oral CR6086, twice a day for 14 days |
| AGEN2034 | BIOLOGICAL | AGEN2034 3 mg/Kg iv on D1 of each 14- day cycle |
Diagnosis and Main Criteria for Inclusion/Exclusion: Inclusion Criteria Main Study - patients with MSS mCRC These criteria are applicable for both Dose Escalation and Expansion part of the Main Study; criteria specific for each study part are identified with ESC=Escalation or EXP=Expansion. 1. Si...