solide tumoren Cancer Solid tumors
Conditions
Interventions
In Part I, cohorts of three patients will receive escalating doses of RO7009789
subcutaneously/intravenously every 28 days (Q4W) on Day 2 of Cycles 1 through
4, and thereafter on Day 2 of every thir
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Part I: Advanced/metastatic histologically confirmed solid tumor (except prostate cancer and squamous NSCLC) not amenable to standard therapy * Part II: Histologically confirmed diagnosis of advanced/metastatic aPROC, HNSCC and non-squamous NSCLC previously treated with anti-PD-L1 inhibitor alone or in combination * Age * 18 years * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy * 16 weeks * Adequate hematologic and organ function * Adequate cardiovascular function * Measurable disease Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Exclusion criteria
Exclusion criteria: * Patients with prostate cancer or squamous NSCLC * Patients who have received prior systemic anti-cancer treatment within the following time frames (see protocol for details) * Treatment with compounds targeting VEGF or VEGF-R within 12 months prior to enrolment (Part II only) * Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1 Day 1 * Chronic daily treatment with non-steroidal anti-inflammatory drugs (NSAIDs). However, occasional use for the symptomatic relief of medical conditions (e.g. headache) is allowed * Patients who have undergone major surgery within 4 weeks prior to study drug administration * Patients who have undurgone any abdominal surgery or interventions (including colonoscopy)or significant abdominal traumatic injury within 60 days prior to Day 1 of Cycle 1 * Known clinically significant liver disease (with the exception of Gilbert's syndrome) * History of peripheral venous thrombosis or thromboembolic event (within 12 months prior to Cycle 1 Day 1) * History of hemoptysis (bronchopulmonary hemorrhage) NCI CTCAE * Grade 2 within 4 weeks prior to study drug administration; * Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety is the primary endpoint and all efficacy endpoints are secondary. Among the efficacy endpoints, for the evaluation of the preliminary antitumor activity of RO7009789 in combination with vanucizumab/bevacizumab, best ORR, objective response rate, DCR, PFS, and OS (if data is mature at the time of analysis) according to RECIST v1.1 will be considered primary. | — |
Secondary
| Measure | Time frame |
|---|---|
| Best ORR, objective response rate, DCR, and PFS will also be assessed according to irRC and will be considered secondary. | — |
Countries
Netherlands
Outcome results
None listed