An Open-label, Phase I/II Multicenter Clinical Trial of NECVAX-NEO1 in Addition to Anti-PD-1 or Anti-PD-L1 Monoclonal Antibody Therapy in Patients with Solid Tumors (NECVAX-NEO1-02-INT).
- Conditions
- Advanced solid tumorsMedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104Therapeutic area: Not possible to specify
- Registration Number
- CTIS2024-511212-24-00
- Lead Sponsor
- EC Bio Therapeutics GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
Patients able to understand and follow instructions during the trial., Patients with adequate renal function at Screening, confirmed at Baseline, defined by estimated glomerular filtration rate (eGFR) =30 mL/min using 2021 CKD-EPI creatinine equation (eGFR =142*min(standardized Scr/K, 1)a*max(standardized Scr/K, 1)-1.200 *0.9938Age *1.012 [if female] where K = 0.7 [females] or 0.9 [males], a = –0.241 [females] or –0.302 [males], min = indicates the minimum of Scr/K or 1, and max = indicates the maximum of Scr/K or 1)., Patients must be able to undergo MRI or CT scan for tumor follow-up., Patients with Eastern Cooperative Oncology Group (ECOG) performance status =2., Life expectancy of at least 6 months at the time of ICF signature, according to the Investigator’s judgement., Patients able and willing to give written informed consent (signed and dated)., Male or female patients., Patients aged at least 18 years old at the time of ICF signature., Patients with solid tumors with measurable disease according to RECIST 1.1, planned to be treated with a PD-1 or PD-L1 inhibitor as first- or second-line standard of care therapy according to national/institutional guidelines., Patients with tumor or metastasis accessible for guided needle biopsy or resection., Patients with adequate bone marrow function at Screening, confirmed at Baseline, including: a) absolute neutrophil count (ANC) =1.5 × 109/L; patients with documented benign cyclical neutropenia are eligible if white blood cell count is =1.5 × 109/L, with ANC =1.0 × 109/L, leukocytes =4.0 × 109/L, and lymphocytes =0.6 × 109/L b) platelets =100 × 109/L c)hemoglobin =9 g/dL (may have been transfused)., International Normalized Ratio (INR) <1.5 × the Upper Limit of Normal (ULN); patients treated with vitamin K antagonist are eligible if INR <3 (at Screening and confirmed at Baseline)., Patients with adequate hepatic function at Screening, confirmed at Baseline, defined by a) total bilirubin level =1.5 × ULN; patients with documented Gilbert disease are allowed if total bilirubin =3 × ULN b) aspartate aminotransferase (AST) level =2.5 × ULN, and alanine aminotransferase (ALT) level =2.5 × ULN, or, for patients with documented metastatic disease to the liver, AST, and ALT levels =5 × ULN.
Medical and surgical history, and diseases: History of any disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, based on the Investigator’s judgement, provides a reasonable suspicion of a disease or condition that contraindicates the use of the IMP or that might affect the interpretation of the trial results or render the patient at high risk for treatment complications., Prior and concomitant medication: Treatment in any other clinical trial medication within 30 days before Screening., Prior and concomitant medication: Any other condition or treatment that, in the opinion of the Investigator, might interfere with the trial., Medical and surgical history, and diseases: Symptomatic brain metastasis., Prior and concomitant medication: Current drug or substance abuse., Prior and concomitant medication: Chronic concurrent therapy within 2 weeks before the trial treatment or expected therapy during the trial treatment period with: a) corticosteroids (except systemic corticosteroids up to 10 mg prednisolone or equivalent daily dose [oral, muscular, or intravenous]). b) immunosuppressive agents. c) antibiotics. d) any other anticancer therapy or concurrent anticancer treatment (except for other checkpoint inhibitors in combination with the anti-PD-1 or anti-PD-L1 monoclonal antibody), for example, cytoreductive therapy, radiotherapy with the exception of palliative short course, limited field (i.e., =10 fractions and =30% bone marrow involvement or per institutional standard) radiotherapy, which may be administered during the trial. However, IMP dosing must be suspended at least 14 days prior to the start of radiotherapy and must not be resumed until at least 14 days after the last radiotherapy fraction, or cytokine therapy, except for erythropoietin., Other: Inability to understand the Protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial., Other: Unlikely to comply with the Protocol requirements, instructions, and trial-related restrictions (e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the trial)., Other: Legal incapacity or limited legal capacity., Other: Any condition which results in an undue risk for the patient during the trial participation according to the Investigator., Medical and surgical history, and diseases: Any significant co-morbidity which, according to the Investigator’s judgement, makes patient compliance to trial conditions unlikely., Medical and surgical history, and diseases: Other severe acute or chronic medical conditions (if there is one of the medical conditions at baseline, the patient should not be treated) including: a) immune colitis. b) inflammatory bowel disease. c) history of severe vomiting or diarrhea not having resolved to Grade 1 at Baseline. d) immune pneumonitis. e) pulmonary fibrosis. f) psychiatric conditions including recent (within the last year) or active suicidal ideation or behavior. g) laboratory abnormalities that may increase the risk associated with trial participation or trial treatment administration or may interfere with the interpretation of trial results and, in the judgement of the Investigator, would make the patient inappropriate for entry into this trial., Medical and surgical history, and diseases: Previous malignant disease (other than the tumor disease for this trial) within the last 5 years (except adequa
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method