An open-label, phase I/II multicenter clinical trial of NECVAX-NEO1 as add-on to first-line neoadjuvant anti-PD-1 monoclonal antibody therapy in patients with triple-negative breast cancer

Phase 1

• Conditions: Triple negative breast cancer (TNBC); MedDRA version: 20.0Level: PTClassification code: 10075566Term: Triple negative breast cancer Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-512520-11-00
• Lead Sponsor: EC Bio Therapeutics GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-23
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Patients able to understand and follow instructions during the trial., Patients with adequate renal function at Screening, confirmed at Baseline, defined by eGFR = 30 mL/min using 2021 CKD-EPI creatinine equation., 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 12 months according to the Investigator’s judgement., Patients able and willing to give written informed consent, signed and dated., Female and male patients., Patients aged at least 18 years old at the time of ICF signature., cT2-4 N0 or any N-positive (stage II-III) triple-negative breast cancer patients diagnosed as candidates for first-line neoadjuvant anti-PD1 monoclonal antibody and chemotherapy epirubicin/cyclophosphamide and nab-paclitaxel therapy, Patients with tumor accessible for biopsy and surgery., Patients with adequate bone marrow function at Screening, confirmed at Baseline, including: a.ANC = 1.5 × 10^9/L; patients with documented benign cyclical neutropenia are eligible if white blood cell count is = 1.5 × 10^9/L, with ANC = 1.0 × 10^9/L, leukocytes = 4.0 × 10^9/L, and lymphocytes = 0.6 × 10^9/L; b.platelets = 100 × 10^9/L; c.hemoglobin = 9 g/dL (may have been transfused);, International Normalized Ratio (INR) < 1.5×Upper Limit of Normal (ULN); patients treated with vitamin K antagonist are eligible if INR < 3., 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.

Exclusion Criteria

Patients with a 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., Patients with a history of uncontrolled intercurrent illness, including but not limited to uncontrolled hypertension (high blood pressure defined as BPD>=140 mmHg or BPS >=90 mmHg despite of combination therapy with diuretic/CCB/ACE or ARB) etc. and uncontrolled diabetes (e.g., hemoglobin A1c = 8%)., Patients with a known prior hypersensitivity to the IMP or any component in its formulations or any other drug scheduled or likely to be given during the trial, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade = 3)., Patients with severe acute or chronic medical conditions, 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., Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at Screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody Screening test positive)., Women who are pregnant or breastfeeding, or women of childbearing potential not willing to use acceptable methods of birth control., Patients with a known history of drug/substance abuse., Patients who received any live vaccines within 30 days prior to trial treatment., Patients participating in any other clinical trial within 30 days before Screening., Patients receiving any other treatment that, in the opinion of the Investigator, might interfere with the trial., Patients with a current drug or substance abuse., Patients with a history of small intestine resection surgery or other major gastrointestinal surgery, Patients receiving chronic concurrent therapy within two (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). b.Immunosuppressive agents. c.Antibiotics. d.Any other anticancer therapy or concurrent anticancer treatment except the neoadjuvant chemotherapy / anti-PD1 checkpoint inhibitor standard of care background therapy as per study protocol., Patients unable to understand the protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial, Patients who are 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., Patients with legal incapacity or limited legal capacity., Patients with any condition which results in an undue risk for the patient during the trial participation according to the Investigator., Patients

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified