IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma

Exclusion Criteria

• •1. Prior chemotherapy for metastatic breast adenocarcinoma
• •2. Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy
• •3. Inflammatory carcinoma
• •4. Candidate for treatment with trastuzumab (or other Her2/neu targeted agents)
• •5. Systemic chemotherapy, radiation therapy or any other investigational agent within 4 weeks, endocrine therapy within 1 week prior to first dose of study treatment or CDK4/6 inhibitors within 5 times half-life (acc.to SPC) prior to first dose of study treatment and until completion of study treatment
• •6. Symptomatic known cerebral and/or leptomeningeal metastases
• •7. Serious intercurrent infection
• •8. Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment
• •9. Active acute or chronic infection
• •10. Active autoimmune disease requiring immunosuppressive therapy
• •11. Previous malignancies within the last three years other than breast carcinoma
• •12. Patients with prior organ or stem cell transplantation
• •13. Any condition requiring continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.