AN OPEN-LABEL, MULTICENTER, DOSE ESCALATION PHASE IB STUDY TO INVESTIGATE THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND THERAPEUTIC ACTIVITY OF RO7009789 (CD40 AGONIST) IN COMBINATION WITH ATEZOLIZUMAB (ANTI-PD-L1) IN PATIENTS WITH LOCALLY ADVANCED AND/OR METASTATIC SOLID TUMORS
- Conditions
- Gevorderde en/of gemetastaseerde solide tumorenadvanced and/or metastatic solid tumorsCancer
- Registration Number
- NL-OMON44807
- Lead Sponsor
- Roche Nederland B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
*Histologically confirmed diagnosis of locally advanced and/or metastatic solid tumors that are not amenable to standard therapy
*Eastern Cooperative Oncology Group Performance Status of 0 or 1
*Life expectancy * 16 weeks
*Adequate hematologic and end organ function
*Measurable disease per RECIST v1.1
*Patient*s ability to comply with the collection of tumor biopsies. Tumors must be accessible for biopsy.
*Consent to undergo pretreatment and/or on-treatment biopsies for PD biomarker analysis
*Any approved anti-cancer therapy that includes chemotherapy, hormonal therapy, or radiotherapy within 2 weeks prior to the first dose of study treatment
*Adverse events from prior anti-cancer therapy that have not resolved to Grade * 1 except for any grade alopecia and * Grade 2 peripheral neuropathy
*Bisphosphonate therapy for symptomatic hypercalcemia. Use of bisphosphonate therapy for other reasons (e.g., bone metastasis or osteoporosis) is allowed.
*Patients who are receiving denosumab prior to enrollment must be willing and eligible to receive a bisphosphonate while on study.
*Uncontrolled pleural effusion, pericardial effusion, or ascites that require recurrent drainage procedures (one monthly or more frequently). Patients with indwelling catheters are allowed.
*Known clinically significant liver disease which includes active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease
*History (within the previous year) of congestive heart failure, stroke, arrhythmia, or myocardial infarction
*History of peripheral venous thrombosis or thromboembolic event (within 12 months prior to Cycle 1 Day 1)
*Significant cardio- or cerebrovascular disease within 6 months prior to Cycle 1 Day 1
*Known hereditary or acquired coagulopathies (e.g., hemophilia, von Willebrand*s disease, cancer-associated diffuse intravascular coagulation)
*Clinically meaningful proteinuria
*Requiring dialysis (peritoneal or hemodialysis)
*Known primary CNS malignancy or symptomatic or untreated CNS metastases
*History of autoimmune diseases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method