A Phase Ib Study of hPV19, a Novel Humanized Monoclonal Antibody Against Vascular Endothelial Growth Factor (VEGF),in Combination With Chemotherapy in Patients With Advanced Solid Tumors Refractory to Standard Therapy.

Number of Participants That Experienced Any Dose-Limiting Toxicities (DLT) During the DLT Assessment Period

时间窗: during the first 21 days

DLTs were adverse events (AEs) possibly related to study drug that met the National Cancer Institute's Common Terminology Criteria for AEs (NCI CTCAE, version 4.03) with any one of the following: 1. Grade 4 neutropenia ≥7 days; febrile neutropenia; grade 4 anemia; grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding; 2. ≥ grade 3 nonhematologic toxicity with the exception of nausea, vomiting, diarrhea, dehydration or electrolyte abnormalities that resolved to a lower grade with maximum supportive treatment within 3 days; 3. ≥Grade 3 hypertension that cannot resolved to a lower grade with supportive treatment within 2 weeks or uncontrolled hypertension; 4. Urine protein ≥3.5 grams/24 hours and cannot resolved to \< 1.0 grams/24 hours within 2 weeks; 5. Gastrointestinal perforation: symptoms, signs and imaging evidence of abdominal pain require surgical treatment; 6. Grade 3 or 4 arterial thromboembolism, including stroke and myocardial infarction;

Number of Participants With hPV19 Drug-Related Adverse Events or Serious Adverse Events

时间窗: Baseline to the last dose plus 28 days.

Data are presented for the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade ≥3 TEAEs, or adverse events (AEs) leading to discontinuation of treatment that were considered to be related to hPV19. Events related to chemotherapy were reported separately.