Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HEC-921 · 1 trial · 1 indication
Proportion of participants with dose limiting toxicities during DLT observation window, to identify monotherapy and combination derive maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).
The severity of adverse events (AEs) will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 6.0.
| Arm | Type | Description |
|---|---|---|
| HEC-921 Monotherapy Study | EXPERIMENTAL | - |
| Combination Therapy Study | EXPERIMENTAL | HEC-921 in combination with capecitabine plus oxaliplatin (CAPOX) and bevacizumab |
| Name | Type | Description |
|---|---|---|
| HEC-921 | DRUG | Patients will receive specific dose of HEC-921 via intravenous infusion. |
| Oxaliplatin | DRUG | 130 mg/m², administered via intravenous infusion on Day 1 |
| Capecitabine | DRUG | 1000 mg/m² per dose, orally twice daily on Days 1-14 |
| Bevacizumab | DRUG | 7.5 mg/kg, administered via intravenous infusion on Day 1 |
Inclusion Criteria: * Trial participants aged ≥18 years at the time of signing the informed consent form, either male or female; * Patients with advanced malignant solid tumors confirmed by histology or cytology, who can provide archived or recently collected tumor tissue sections (recently collect...