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:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT02225002
Eligibility Criteria:
Inclusion Criteria:
* Men and women at least 18 years old with advanced solid tumors relapsed or refractory to standard therapy or for whom no effective therapy exists;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1;
* Adequate bone marrow function documented within 2 weeks prior to treatment, defined as:
* White blood cell (WBC) count \>3000 cells/μL without growth factor support;
* Absolute neutrophil count (ANC) ≥1500/μL without growth factor support;
* Platelets \>100,000/μL without growth factor support; and
* Hemoglobin ≥10 g/dL;
* D-dimer WNL;
* Adequate renal and hepatic function documented within 2 weeks prior to treatment, defined as:
* Total bilirubin \<1.5 times the upper limit of normal (ULN);
* Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \<2.5 × ULN;
* Creatinine clearance (CLcr, measured or calculated) \>80 mL/min; and
* Life expectancy of at least 12 weeks;
* Fully recovered from the acute effects of prior cancer therapy: 4 weeks for chemotherapy (8 weeks for mitomycin C or nitrosoureas), 10 days for prior palliative radiation therapy or hormonal therapy, and 4 weeks for prior immunotherapy or other biologic therapy; and
* Signed written informed consent.
Exclusion Criteria:
* Previously treated with any other agent that targets CD40;
* Concurrent treatment with any anticancer agent;
* History of autoimmune disorder, including pemphigus vulgaris, systemic mastocytosis, systemic lupus erythamatosus, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen's syndrome, vasculitis/arteritis, Behcet's syndrome, inflammatory boweldisease, autoimmune thyroiditis, multiple sclerosis, or other chronic inflammatory disease;
* Treatment with any other investigational therapy within 4 weeks prior to baseline;
* History (within the previous year) of congestive heart failure, stroke, or myocardial infarction;
* Patients with known hereditary or acquired coagulopathies (eg. hemophilia, von Willebrand's disease, cancer-associated DIC, abnormal D-dimer);
* Patients with known brain metastases. Patients with clinical evidence suggestive of new brain metastases prior to enrollment are excluded if brain metastases have not been ruled out via CT or MRI. Patients with previously diagnosed brain metastases are eligible if they have completed their CNS treatment and have recovered from the acute effects of radiation therapy or surgery prior to the start of study medication, have discontinued corticosteroid treatment for these metastases for at least 4 weeks, and are neurologically stable;
* Patients having reproductive potential who are not using an effective method of birth control or who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test during baseline;
* Known sensitivity to immunomodulating agents or monoclonal antibodies;
* Alcohol abuse or illicit drug use within 12 months of enrollment;
* History of serum creatinine ≥2 mg/dL for any duration and for any reason;
* Patients, other than menstruating females, with urine dipstick 1+ or more positive for blood or 2+ or more positive for protein;
* Patients with clinically significant presence of granular or cellular casts in centrifuged urine sediment;
* Patients with renal carcinoma or renal metastases;
* Patients that have had a partial or complete nephrectomy;
* Patients requiring dialysis (peritoneal or hemodialysis);
* Prior treatment with Amphotericin B or cisplatin;
* Patients with history of insulin-dependent diabetes for greater than 5 years;
* Concomitant treatment with systemic high dose corticosteroids or treatment with systemic corticosteroids within 4 weeks of baseline;
* Concomitant treatment with anticoagulants, such as coumadin or heparin, except to maintain patency of in-dwelling catheters;
* Prior allergic reactions attributed to compounds of similar chemical or biologic composition to study drug (eg, rituximab or immunoglobulin G);
* Ongoing or active infection;
* Required the use of systemic antibiotics or antifungals for ongoing or recurrent infections.
Topical use of antibiotics or antifungals is allowed;
* Other uncontrolled concurrent illness that would preclude study participation; or
* Psychiatric illness or social situation that would preclude study participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02225002
Study Brief:
Protocol Section:
NCT02225002