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

This multicenter Phase 2a study was designed to evaluate the safety, tolerability, and efficacy of Promitil in patients with recurrent ovarian cancer and inoperable, locally advanced or metastatic pancreatic cancer, which bears deleterious germline or somatic mutations in BRCA1, BRCA2, or HRD (homologous recombination deficiency) -related genes. Based on reported preclinical and clinical efficacy of Mitomycin C in BRCA-mutated tumors, and together with the demonstrated improved safety profile of Promitil in humans, it is expected that this liposomal formulation will have a favorable therapeutic index and significant clinical antitumor activity in patients with tumors bearing BRCA 1/2 and/or PALB2 mutations.

The study will include a Screening, Treatment Phase and Long-Term Follow-up (LTFU) Phase. Upon signing the informed consent form, all subjects will undergo screening procedures to assess eligibility within 21 days prior to receiving study drug. Eligible subjects will be intravenously (IV) administered 2.0 mg/kg Promitil on Day 1 of each 28-day cycle, for up to 6 cycles. Subjects who complete the 6-cycle Treatment Phase have the option to continue to receive Promitil until disease progression, death, unacceptable toxicity or withdrawal of consent. During the 6-month Treatment Phase, safety assessments will be conducted at each study visit (Days 1, 2, 4,8 and 14 of Cycle 1, Day 1 of Cycle 2 and Cycles 4 and beyond and Days 1, 2 4,and 8 of Cycle 3). Safety will be assessed by measurement of weight, physical examinations, vital signs, ECG recordings, blood chemistry, hematologic and urinalysis parameters, and review of Adverse and Serious Adverse events (SAEs) and concomitant medications. Response will be assessed by CT/MRI/PET-CT scans and biomarker levels, with imaging conducted every 12 weeks (every 3 treatment cycles).For patients who stopped receiving Promitil for any reason other than disease progression, response will continue to be assessed every 12 weeks, until disease progression, death or withdrawal of consent, but no later than 1 year from first dose of Promitil. Once study treatment ends, all subjects will be followed up long-term, with survival status assessed every 3 months for up to 1 year or until death, the earlier of the two.