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

Summary

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.

Timeline

Start

2024-06-13

Primary completion

2026-01-02

Completion

2026-01-02

Outcome

Outcome not reported

Stopped (Business): “Sponsor decision”

Publications

• Background Gabizon A, Shmeeda H, Tahover E, Kornev G, Patil Y, Amitay Y, Ohana P, Sapir E, Zalipsky S. Development of Promitil(R), a lipidic prodrug of mitomycin c in PEGylated liposomes: From bench to bedside. Adv Drug Deliv Rev. 2020;154-155:13-26. doi: 10.1016/j.addr.2020.07.027. Epub 2020 Aug 7.
• Background Gabizon AA, Tahover E, Golan T, Geva R, Perets R, Amitay Y, Shmeeda H, Ohana P. Pharmacokinetics of mitomycin-c lipidic prodrug entrapped in liposomes and clinical correlations in metastatic colorectal cancer patients. Invest New Drugs. 2020 Oct;38(5):1411-1420. doi: 10.1007/s10637-020-00897-3. Epub 2020 Jan 18.

Drugs

Indications