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 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT01012102
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects ≥18 years of age
* Signed written informed consent
* Histologically or cytologically documented metastatic or locally advanced survivin-expressing solid tumor for which no established therapy exists
* Disease must be measurable by RECIST criteria or evaluable by clinical, radiographic, or laboratory criteria established for the given tumor entity
* Expressing at least one of the following HLA alleles:HLA-A1,-A2,-A3,-A24, and -B7 assessed by HLAgenotyping
* ECOG performance status of ≤1, estimated life expectancy of at least 3 months
* Adequate hematological function defined by WBC ≥3 x 10x9/L, lymphocyte count ≥0.5 x 10x9/L, hemoglobin ≥10 g/dL, platelet count ≥100 x 10x9/L
* Adequate blood coagulation parameters defined as aPTT and INR ≤ 1.5 x ULN
* Adequate renal function defined by a serum creatinine ≤2 x ULN
* Adequate hepatic function defined by total bilirubin ≤2 x ULN and AST and ALT levels ≤2.5 x ULN (in subjects with liver metastases ≤5 x ULN)
* Effective contraception for female and male subjects if the risk of conception exists
Exclusion Criteria:
* Treatment in another clinical study within the past 30 days prior to the first administration of study treatment
* Previous treatment with an investigational anticancer vaccine
* Requirement of concurrent treatment with a nonpermitted drug
* Active significant autoimmune disease (with the exception of vitiligo)
* Receipt of allogeneic stem cell transplantation
* Significant acute or chronic infections (e.g. viral hepatitis, HIV)
* Primary brain tumors and brain metastases (with the exception of brain metastases that are stable after irradiation or surgically resected brain metastases if subjects have been asymptomatic for ≥6 months)
* Rapidly progressive disease (e.g. tumor lysis syndrome)
* Radiotherapy, chemotherapy, surgery (excluding prior diagnostic biopsy), immunotherapy or any investigational drug within 30 days before the start of study treatment
* Pregnancy or lactation
* Active drug or alcohol abuse
* Known hypersensitivity to the study treatment or any of its components
* Any significant disease that, in the Investigator's opinion, should exclude the subject from the study; for questions about this criterion, the Investigator should contact the sponsor.
* Persisting toxicity related to prior therapy ≥grade 2 National Cancer Institute-Common Terminology Criteria For Adverse Events version 3.0
* Legal incapacity or limited legal capacity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01012102
Study Brief:
Protocol Section:
NCT01012102