Iadademstat in Combination With Paclitaxel in Relapsed/Refractory SCLC and Extrapulmonary High Grade NET

Exclusion Criteria

• •1. Patients who have received more than 3 lines of therapy
• •2. Patients who have not received any platinum-based therapy
• •3. Patients who have received previous therapy with taxanes, unless received in the neoadjuvant/adjuvant setting and longer than six months from last taxane treatment.
• •4. ECOG performance status \>/=2
• •5. Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen as per treating MD
• •6. Patients who have received radiotherapy less than 2 weeks prior to first dose of study medication.
• •7. Surgical procedure or clinically significant trauma within 4 weeks of first dose of study treatment.
• •8. Treatment with any investigational agent ≤ 3 weeks prior to first dose of study treatment.
• •9. Patients with gastrectomy or pre-existing gastrointestinal (GI) disorders that may interfere with the proper absorption of the drug(s), as per conclusion of the clinical Investigator.
• •10. Patients medicated with, or the expected need for treatment with agents reported to have LSD1 inhibitory activity (such as tranylcypromine or phenelzine) within 3 weeks of treatment start also refer to section 5.2 for the list of concomitant medications.
• •11. History of allergic reactions attributed to components of the formulated product(s). (see appendix)
• •12. Patients with prior history of NCI CTCAE Grade ≥ 3 drug-related central nervous system (CNS) toxicity.
• •13. Patients with untreated, symptomatic CNS metastases likely to interfere with the experimental therapy as per the investigator-sponsor
• •14. Patients with prior history of grade ≥2 neurotoxicity that was not resolved to grade ≤1 (prior therapy toxicity)
• •15. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study or pose a higher risk of toxicities as per discretion of the treating physician in agreement with the investigator-sponsor (including but not limited to:)
• •1. Unstable angina, symptomatic or otherwise uncontrolled arrhythmia (does not include stable, lone atrial fibrillation), QTcF \> 480 ms based on the average of 3 screening electrocardiograms (ECGs), symptomatic congestive heart failure (NYHA II, III, IV), myocardial infarction ≤ 6 months prior to first study treatment, cerebrovascular accidents ≤ 6 months before study treatment start.
• •2. Patient has evidence of active uncontrolled viral, bacterial, or systemic fungal infection.
• •3. Any other serious and uncontrolled medical illnesses, uncontrolled seizures that may affect study participation or patient safety, as assessed by investigator.
• •16. Patients who refuse or are unable to potentially receive blood products
• •17. Any medical condition which, in the opinion of the Investigator, places the patient at an unacceptable risk for toxicities if entered into the clinical study.
• •18. Patients with history of clinically significant bleeding, specifically any history of intracranial hemorrhage / hemorrhagic cardiovascular accident (CVA), or patients with gastrointestinal bleeding within the 3 months prior to study entry.
• •19. Patients with current interstitial lung disease, requiring systemic therapy within the last 3 months.
• •20. Patients with hypersensitivity to iadademstat, paclitaxel, or to any of its excipients.
• •21. Patients with known irreversible bleeding disorders or receiving antiplatelet therapy for other indications. Use of low dose aspirin (\<100 mg) is allowed.
• •22. Patients pregnant or breast feeding. Refer to section 4.4 for further detail. Female patient must agree not to breastfeed at screening and throughout the study period and for 60 days after the final study drug administration.