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

NCT06478862 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-01-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Promitil

The 10 patients recruited in each of the cohorts will receive 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.

Sponsors & Collaborators

  • Lipomedix Pharmaceuticals Inc.

    lead INDUSTRY

Principal Investigators

  • Ora Rosengarten, MD · Shaare Zedek

  • Ofer Purim, MD · Shaare Zedek Medical Center

  • Ravit Geva, MD · Sourasky Medical Center

  • Amichai Meirovitz, MD · Soroka University Medical Center

  • Ruth Peretz, MD · Rambam Health Care Campus

  • Nirit Yarom, MD · Asaf Harofeh Medical Center

  • Tali Levy, MD · Wolfson Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-13
Primary Completion
2026-01-02
Completion
2026-01-02

Countries

  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06478862 on ClinicalTrials.gov