AN OPEN LABEL, MULTICENTER, RANDOMIZED DOSE-ESCALATION AND EXTENSION, PHASE IA/IB STUDY TO EVALUATE SAFETY AND ANTI-TUMOR ACTIVITY OF RO7284755, A PD-1 TARGETED IL-2 VARIANT (IL-2V) IMMUNOCYTOKINE, ALONE OR IN COMBINATION WITH ATEZOLIZUMAB IN PARTICIPANTS WITH ADVANCED AND/OR METASTATIC SOLID TUMORS
- Conditions
- metastatic solid tumors
- Registration Number
- NL-OMON55111
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 34
- 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 < 1% per year during the treatment
period and for at least 1 month after last dose of RO7284755 or at least 5
months after the last dose of atezolizumab whichever is longer
- 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 <=1,
except alopecia Grade 2 peripheral neuropathy, and hypothyroidism and/or
hypopituitarism on a stable dosage of hormone replacement therapy
- Participants with bilateral pleural effusion
- Major surgery or significant traumatic injury < 28 days before study
treatment administration or anticipation of the need for major surgery during
study treatment
- Known allergy or hypersensitivity to any component of the formulations of
the IMPs to be administered, including but not limited to hypersensitivity to
Chinese hamster ovary cell products or other recombinant or humanized antibodies
- History of severe allergic anaphylactic reactions to chimeric, human or
humanized antibodies, or fusion proteins
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary objectives:<br /><br>- To evaluate the safety and tolerability of RO7284755 alone (Part 1) or in<br /><br>combination with atezolizumab (Part 2)<br /><br>Endpoint: Incidence, nature, and severity of adverse events (AEs) graded<br /><br>according to the National Cancer Institute (NCI) Common Terminology Criteria<br /><br>for Adverse Events (CTCAE)<br /><br><br /><br>- To determine the maximum-tolerated dose (MTD) and/or the recommended dose for<br /><br>extension (RDE) of RO7284755 (Part 1 and Part 2) Endpoint: Nature and frequency<br /><br>of dose-limiting toxicities (DLTs)<br /><br><br /><br><br /><br>- To evaluate the anti-tumor activity of study treatment (Part 3)<br /><br>Endpoint: Objective response rate (ORR) according to RECIST v1.1</p><br>
- Secondary Outcome Measures
Name Time Method <p>To evaluate the anti-tumor activity of study treatment (Part 1 and Part 2)<br /><br><br /><br>To evaluate the safety and tolerability of the study treatment (Part 3)<br /><br><br /><br>The precise secondary and Exploratory objectives and endpoints are stated in<br /><br>section3, table 9 of the protocol.</p><br>