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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005877-22 | EudraCT Number | ||
| RG7221 | Other Identifier | Roche |
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This multi-center, open-label study will evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of vanucizumab as a single agent or in combination with atezolizumab in participants with locally advanced or metastatic solid tumors. Cohorts of participants will receive escalating doses of vanucizumab, fixed dose of vanucizumab (MTD and/or recommended phase two dose [RP2D]), and fixed dose of vanucizumab in combination with atezolizumab, intravenously every 2 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vanucizumab | Experimental | Participants will receive escalating doses of vanucizumab and fixed dose of vanucizumab, intravenously every 2 weeks. |
|
| Vanucizumab + Atezolizumab | Experimental | Participants will receive fixed dose of vanucizumab along with atezolizumab, intravenously every 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab [TECENTRIQ] | Biological | Participants will receive atezolizumab at a fixed dose of 840 mg, intravenously every 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Vanucizumab | approximately 28 days | |
| Number of Participants With Objective Response According to RECIST 1.1 Criteria | approximately 3 years | |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | approximately 3 years | |
| Number of Participants With Dose-limiting Toxicities (DLTs) | approximately 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Elimination Half-life (t1/2) of Vanucizumab | Cycle 1 & 4: 0 hour (pre-dose), end of infusion (maximum up to 120 minutes); Cycle 2, 3, 8, every 8 weeks after cycle 8: 0 hour (pre-dose) | |
| Area Under the Plasma Concentration-time Curve During one Dosing Interval (AUCtau) of Vanucizumab |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium | |||
| UZ Leuven Gasthuisberg |
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| Vanucizumab | Biological | Participants will receive escalating doses of vanucizumab (starting dose: 3 milligram [mg] per kilogram) and fixed dose of vanucizumab (MTD/RP2D: 30 mg/kg), intravenously every 2 weeks. |
|
|
| Cycle 1 & 4: 0 hour (pre-dose), end of infusion (maximum up to 120 minutes); Cycle 2, 3, 8, every 8 weeks after cycle 8: 0 hour (pre-dose) |
| Clearance of Study Drug From the Body (CL) | Cycle 1 & 4: 0 hour (pre-dose), end of infusion (maximum up to 120 minutes); Cycle 2, 3, 8, every 8 weeks after cycle 8: 0 hour (pre-dose) |
| Volume of Distribution at Steady-State (Vss) of Vanucizumab | Cycle 1 & 4: 0 hour (pre-dose), end of infusion (maximum up to 120 minutes); Cycle 2, 3, 8, every 8 weeks after cycle 8: 0 hour (pre-dose) |
| Accumulation Ratio (RA) of Vanucizumab | Cycle 1 & 4: 0 hour (pre-dose), end of infusion (maximum up to 120 minutes); Cycle 2, 3, 8, every 8 weeks after cycle 8: 0 hour (pre-dose) |
| Number of Participants With Objective Response According to RECIST 1.1 Criteria, CA-125 Response Criteria, and Immune-modified RECIST Criteria | approximately 3 years |
| Number of Participants With Disease Control According to RECIST 1.1 Criteria | approximately 3 years |
| Progression Free Survival (PFS) According to RECIST 1.1 Criteria | Baseline until disease progression or death (up to approximately 3 years) |
| Biological Progression-free Interval (PFIbio) According to RECIST 1.1 Criteria | Baseline until biologic progression or death (up to approximately 3 years) |
| Overall Survival (OS) | Baseline until death (up to approximately 3 years) |
| Change From Baseline in Micro Vessel Density (MVD) Assessed by Paired Tumor Biopsies | approximately 2 years |
| Change From Baseline in Proliferation and Apoptosis of Endothelial cells and Tumor Cells Assessed by Paired Tumor Biopsies | approximately 2 years |
| Change From Baseline in Maturity of Blood Vessels Assessed by Paired Tumor Biopsies | approximately 2 years |
| Change From Baseline in Targets and Receptors Assessed by Paired Tumor Biopsies | approximately 2 years |
| Change From Baseline in Blood Plasma Volume (Vp), Extracellular Extravascular Space Volume (Ve), and Volume Transfer Coefficient, Assessed by Bio-Imaging | approximately 2 years |
| Change From Baseline in Apparent Diffusion Coefficient (ADC) Assessed by Bio-Imaging | approximately 2 years |
| Percentage of Participants With Human Anti-Human Antibodies (HAHA) to Vanucizumab and Atezolizumab (ATA) | 0 hours (pre-dose) in Part I, II, and III (Cycle 1, 5, 6, end of study [EoS] visit) Part IV (Cycle 1, 3, 4, 8, every 8 weeks after cycle 8, EoS visit) |
| Area under the Concentration-time Curve (AUC) of Vanucizumab | Cycle 1 & 4: 0 hour (pre-dose), end of infusion (maximum up to 120 minutes); Cycle 2, 3, 8, every 8 weeks after cycle 8: 0 hour (pre-dose) |
| Maximum Observed Plasma Concentration (Cmax) of Vanucizumab | Cycle 1 & 4: 0 hour (pre-dose), end of infusion (maximum up to 120 minutes); Cycle 2, 3, 8, every 8 weeks after cycle 8: 0 hour (pre-dose) |
| Minimum Observed Plasma Concentration (Cmin) of Vanucizumab | Cycle 1 & 4: 0 hour (pre-dose); Cycle 2, 3, 8, every 8 weeks after cycle 8: 0 hour (pre-dose) |
| Time of Observed Maximum Plasma Concentration (Tmax) | Cycle 1 & 4: 0 hour (pre-dose), end of infusion (maximum up to 120 minutes); Cycle 2, 3, 8, every 8 weeks after cycle 8: 0 hour (pre-dose) |
| Leuven |
| 3000 |
| Belgium |
| Institut Bergonie; Oncologie | Bordeaux | 33076 | France |
| Centre Francois Baclesse; Oncologie | Caen | 14076 | France |
| Centre Leon Berard; Departement Oncologie Medicale | Lyon | 69373 | France |
| Institut Curie; Oncologie Medicale | Paris | 75231 | France |
| ICO - Site René Gauducheau | Saint-Herblain | 44805 | France |
| Institut Gustave Roussy; Sitep | Villejuif | 94805 | France |
| Clinica Universitaria de Navarra; Servicio de Oncologia | Pamplona | Navarre | 31008 | Spain |
| Hospital del Mar; Servicio de Oncologia | Barcelona | 08003 | Spain |
| Hospital Univ Vall d'Hebron; Servicio de Oncologia | Barcelona | 08035 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | 28041 | Spain |
| Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica | Madrid | 28050 | Spain |
| Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia | Valencia | 46010 | Spain |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| C000619444 | vanucizumab |
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