metastatic solid tumors metastatic solid tumors
Conditions
Interventions
For the purpose of the study, RO7284755 and atezolizumab are considered
investigational medicinal products (IMPs).
An overview of all treatments is given in Tables 1-4 and 7.
In Figures 1-3 of the p
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age >=18 years - Locally advanced/unresectable or metastatic disease - Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) - Eastern Cooperative Oncology Group Performance Status 0 to 1 - Life expectancy of >= 12 weeks - Consent to provide an archival tumor tissue sample - Adequate cardiovascular, hematological, coagulative, hepatic and renal function - Female Participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, woman of childbearing potential (WOCBP) must agree to remain abstinent or use of two, highly effective contraceptive methods that result in a failure rate of
Exclusion criteria
Exclusion criteria: - Rapid disease progression or suspected hyperprogression or threat to vital organs or critical anatomical sites requiring urgent alternative medical intervention - Known active central nervous system (CNS) metastases - History of treated asymptomatic CNS metastases - Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >= 2 weeks before Cycle1 Day 1 (C1D1) - Active or history of carcinomatous meningitis/leptomeningeal disease - Uncontrolled tumor-related pain or symptomatic hypercalcemia - Concurrent second malignancy - Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results - Episode of significant cardiovascular/cerebrovascular acute disease within 28 days before study treatment administration - Active or uncontrolled infections - Known HIV infection - Hepatitis B virus (HBV) or hepatitis C virus infection - Adverse events related to any prior radiotherapy, chemotherapy, targeted therapy, CPI therapy or surgical procedure must have resolved to Grade
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objectives: - To evaluate the safety and tolerability of RO7284755 alone (Part 1) or in combination with atezolizumab (Part 2) Endpoint: Incidence, nature, and severity of adverse events (AEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) - To determine the maximum-tolerated dose (MTD) and/or the recommended dose for extension (RDE) of RO7284755 (Part 1 and Part 2) Endpoint: Nature and frequency of dose-limiting toxicities (DLTs) - To evaluate the anti-tumor activity of study treatment (Part 3) Endpoint: Objective response rate (ORR) according to RECIST v1.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the anti-tumor activity of study treatment (Part 1 and Part 2) To evaluate the safety and tolerability of the study treatment (Part 3) The precise secondary and Exploratory objectives and endpoints are stated in section3, table 9 of the protocol. | — |
Countries
Netherlands
Outcome results
None listed