A Study of Anti-VEGF Monoclonal Antibody hPV19 in Patients With Solid Tumors

Browse trials for

• Neoplasms 9,365

Keywords

• mAb
• VEGF
• antibody
• phase1

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 18 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Lead sponsor

This is the only study on the registry with SuZhou Stainwei Biotech Inc. as lead sponsor.

Study arms

• Experimental
  group 1

  hPV19 mAb plus FOLFOX(5-Fluorouracil,Oxaliplatin,Leucovorin)

  Biological: hPV19 mAb · Drug: 5-Fluorouracil · Drug: Oxaliplatin · Drug: Leucovorin

• Experimental
  group 2

  hPV19 mAb plus paclitaxel/carboplatin

  Biological: hPV19 mAb · Drug: Paclitaxel · Drug: Carboplatin

• Experimental
  group 3

  hPV19 mAb plus gemcitabine/carboplatin

  Biological: hPV19 mAb · Drug: Gemcitabine · Drug: Carboplatin

• Experimental
  group 4

  hPV19 mAb plus FOLFIRI(5-Fluorouracil,Irinotecan, Leucovorin)

  Biological: hPV19 mAb · Drug: 5-Fluorouracil · Drug: Leucovorin · Drug: Irinotecan

Interventions

• BiologicalhPV19 mAb

  Intravenous (IV) infusions, 4 and 6 milligrams per kilogram (mg/kg) every 2 weeks

  Also known as: anti-VEGF mAb

• BiologicalhPV19 mAb

  Intravenous (IV) infusions, 6 milligrams per kilogram (mg/kg) every 3 weeks

  Also known as: anti-VEGF mAb

• Drug5-Fluorouracil

  400 mg/m2 bolus followed by a 2400 mg/m2 continuous infusion, every 2 weeks

• DrugOxaliplatin

  IV Infusion, 85 milligrams per square meter (mg/m2) every 2 weeks

• DrugLeucovorin

  IV infusion, 400 mg/m2 every 2 weeks

• DrugPaclitaxel

  IV infusion, 175 mg/m2 every 3 weeks

• DrugCarboplatin

  IV infusion, AUC=6 every 3 weeks

• DrugGemcitabine

  IV infusion, 1000 mg/m2 at day1 and day 8 every 3 weeks

• DrugCarboplatin

  IV infusion, AUC=4 every 3 weeks

• DrugIrinotecan

  IV Infusion,180 milligrams per square meter (mg/m2) every 2 weeks

Primary outcomes

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

   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;

   Time frame: during the first 21 days

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

   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.

   Time frame: Baseline to the last dose plus 28 days.

Secondary outcomes

1. Number of Participants With Serum Anti-hPV19 Antibodies (Immunogenicity)

   Time frame: before Single dose; Day 21 of 21-day DLT assessment period; Every 8 or 9 weeks after 21-day DLT assessment period.

2. Maximum Concentration (Cmax) of hPV19

   Time frame: Single dose(Cycle 1)：2h before administered; after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min.

3. Area Under the Curve (AUC) of hPV19

   Time frame: Single dose(Cycle 1)：2h before administered, after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min.

4. Half Life (t1/2) of hPV19

   t1/2 is the time required for the plasma/serum concentration to decrease 50%

   Time frame: Single dose(Cycle 1)：2h before administered, after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min.

5. Clearance (CL) of hPV19

   Time frame: Single dose(Cycle 1)：2h before administered, after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min.

6. Steady State Volume of Distribution (Vss) of hPV19

   Vss is the theoretical volume in which the total amount of study drug would need to be uniformly distributed during steady state to produce the same concentration as it is in plasma/serum

   Time frame: Single dose(Cycle 1)：2h before administered; after administered 10min±5min、4h±30min、24h±1h、168h±1h、336h±1h. Other cycles: 2h before administered and after administration 10min±5min.

7. Best Overall Response [Anti-Tumor Activity of hPV19 Plus Chemotherapy]

   Best overall response evaluated using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Progressive Disease (PD): an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). In addition, the sum must have demonstrated an absolute increase of at least 5 mm (the appearance of 1 or more new lesions was considered progression). Stable Disease (SD): neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started.

   Time frame: Up to six months after 1st treatment or until progression of disease (PD)