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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07281716 | Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic MSS CRC | PHASE1 | RECRUITING | 24 | — | — | Dec 1, 2025 | Dec 15, 2028 | Feb 19, 2026 | 1 | United States |
For the Phase 1b portion, Dose-Limiting Toxicities (DLTs) will be assessed based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Adverse events are graded on a scale from 1 (mild) to 5 (death related to AE). Permanent discontinuation of study treatment will occur for any severe (Grade 3) drug-related adverse event that recurs or for any life-threatening (Grade 4) event.
For the phase 2 portion, ORR will be assessed based on the definition, as the combined percent of the subjects experiencing a partial response (PR) or a complete response (CR) at anytime within the first year from the initiation of therapy, or until the documented progression of disease or start of a new anti-cancer therapy. Radiographic response will be determined by the RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| Nadunolimab and Toripalimab | EXPERIMENTAL | Participants will receive the investigational combination of nadunolimab and toripalimab. Treatment will continue for up to 1 year or until disease progression, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| Nadunolimab | DRUG | 5 mg/kg intravenously (IV) every 3 weeks (Q3W) |
| Toripalimab | DRUG | 240 mg IV every 3 weeks (Q3W) |
Inclusion Criteria: * Patients must have a pathologically confirmed diagnosis of non-MSI-H/pMMR CRC. * Patients must have progressed (clinically or radiographically) on or after standard chemotherapy, including fluoropyrimidines, oxaliplatin, and irinotecan, or are intolerant to standard chemothera...