Disease
|
Advanced cancer/solid tumor only |
Stage of Disease/Treatment
|
Metastatic/advanced |
Prior Therapy
|
No designated number of regimens |
Type of Study
|
Phase I, dose escalation + dose exploration |
Primary Endpoint
|
Safety, tolerability |
Secondary Endpoints
|
Maximum tolerated dose, recommended phase II dose, pharmacodynamics, other |
Additional Details of Endpoints or Study Design
|
The study included dose escalation and dose exploration. For the dose escalation, a modified 3+3 design was used, with dose‐limiting toxicity (DLT) evaluated up to 28 days after the first dose. Eight dose levels were evaluated. The first three dose levels were assessed in single‐patient cohorts. If a grade ≥2 drug‐related adverse event (AE) was observed during the DLT period, two additional patients were enrolled and administered the same dose. For the remaining dose levels, a standard 3+3 design was followed. In the dose exploration, patients received envafolimab 300 mg SC once every 4 weeks (Q4W). |
Investigator's Analysis
|
Active and should be pursued further |