Promitil Treatment of Patients With Solid Tumors Associated With Deleterious Mutations Who Have Progressed After Therapy

Inclusion Criteria

• •1. 18 years of age or older on day of consent
• •2. Patient with either one of the following histologically or cytologically confirmed, deemed incurable malignancies:
• •1. Recurrent ovarian cancer
• •2. Inoperable, locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
• •3. Patient with PDAC measurable by RECIST 1.1. Previously irradiated lesions may be considered measurable if there has been demonstrated progression in these lesions. Ovarian cancer patients can have either measurable or non-measurable lesions (i.e., ovarian cancer patients with mostly ascites or pleural effusion are eligible)
• •4. Tumor with a known pathogenic or likely pathogenic germline or somatic mutation in BRCA1, BRCA2 or HRD-related genes as determined by a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalently accredited laboratory. Note: Patients with positive HRD score can be eligible regardless of any evidence for germline or somatic mutations
• •5. Patient received at least 1 line of chemotherapy for advanced pancreatic adenocarcinoma or ovarian cancer. Prior neoadjuvant and adjuvant chemotherapy are allowed, and platinum re-challenge is allowed for ovarian cancer patients for whom it is felt to be in their best interests, as determined by the Investigator. Prior PARP inhibitor, hormonal, biological, or immunological therapy are allowed. Palliative radiation therapy is allowed, provided it was/will be completed ≥2 weeks prior starting trial therapy
• •6. Capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
• •7. ECOG performance status of 0 or 1
• •8. Adequate organ function as defined by:
• •1. Absolute neutrophil count (ANC) ≥ 1500/µL
• •2. Platelet count ≥ 100,000/µL
• •3. Hemoglobin ≥ 9.5 g/dL
• •4. Hematocrit ≥30%
• •5. Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
• •6. AST and ALT ≤ 3 x ULN OR ≤ 5 x ULN in the presence of liver metastases
• •7. Albumin ≥ 3g/dL
• •8. INR\<1.5 unless on anticoagulants
• •9. Creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 45 mL/minute (as calculated by the Cockcroft-Gault formula)
• •10. Estimated life expectancy of at least 3 months
• •11. Patients (men and women) of reproductive potential willing and able to use an acceptable method of birth control as approved by the PI