Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
NCT ID:
NCT02004106
Eligibility Criteria:
Inclusion Criteria:
* Participants with confirmed advanced and/or metastatic solid tumor, with at least one tumor lesion of non-critical location accessible to biopsy who have progressed on the standard of care therapy
* Locally confirmed CEA expression in tumor tissue (more than \[\>\] 20 percent (%) of tumor cells staining with at least moderate intensity) or centrally confirmed CEA expression if no archival tumor tissue and fresh biopsy is collected
* Radiologically measurable and clinically evaluable disease
* Life expectancy of greater than or equal to (\>/=) 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
* All acute toxic effects of any prior radiotherapy, chemotherapy or surgical procedure must have resolved to Grade \</=1, except alopecia (any grade) and Grade 2 peripheral neuropathy
* Adequate hematological, liver, and renal function
* Negative serum pregnancy test within 7 days prior to study treatment in premenopausal women and women \</=2 years after menopause
* Participants with Gilbert's syndrome will be eligible for the study. A diagnosis of Gilbert's syndrome will be based on the exclusion of other diseases based on the following criteria: (i) unconjugated hyperbilirubinemia noted on several occasions; (ii) no evidence of hemolysis (normal hemoglobin, reticulocyte count, and Lactate dehydrogenase); (iii) normal liver function tests; (iv) absence of other diseases associated with unconjugated hyperbilirubinemia
Exclusion Criteria:
* History or clinical evidence of central nervous system (CNS) primary tumors or metastases including leptomeningeal metastases unless they have been previously treated, are asymptomatic and have had no requirement for steroids or enzyme inducing anticonvulsants in the last 14 days before screening
* Participants with an active second malignancy (other than non-melanoma skin cancer, or cervical carcinoma in situ). Participants who have a history of malignancy are not considered to have an active malignancy if they have completed therapy and are considered by their treating physician to be at less than (\<) 30% risk for relapse
* Evidence of significant, uncontrolled concomitant diseases which could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders and known autoimmune diseases
* Uncontrolled hypertension (systolic \>150 millimeter of mercury \[mmHg\] and/or diastolic \>100 mmHg), unstable angina, congestive heart failure (CHF) of any New York Heart Association (NYHA) classification, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months of enrollment
* Active or uncontrolled infections
* Known infection with human immunodeficiency virus (HIV), seropositive status
* Positive test results for chronic hepatitis B infection (defined as positive Hepatitis B surface antigen \[HBsAg\] serology and/or HBcAb status)
* Positive test results for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing)
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
* Pregnant or breast-feeding women
* Known hypersensitivity to any of the components of RO6895882
* Concurrent therapy with any other investigational drug
* Regular immunosuppressive therapy (that is, for organ transplantation, chronic rheumatologic disease)
* Chronic use of steroids (including inhaled) will not be allowed. Concurrent high doses of systemic corticosteroids. High dose is considered as \>20 mg of dexamethasone a day (or equivalent) for \>7 consecutive days
* Radiotherapy within the last 4 weeks before start of study drug treatment with the exception of limited field palliative radiotherapy for bone pain relief
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02004106
Study Brief:
Protocol Section:
NCT02004106