NCT06620029

BMX-001 + Paclitaxel in Adult Patients With Advanced, Recurrent, Metastatic Ovarian or Endometrial Cancer

Not yet recruiting Phase 1, PHASE2 Last updated 1 October 2024

What this trial tests

Phase 1, PHASE2 trial testing BMX-001 in Ovarian Neoplasms in 27 participants. Not yet recruiting.

Timeline

1 April 2025

Primary endpoint
31 March 2027

31 July 2027

Quick facts

Lead sponsor	BioMimetix JV, LLC
Phase	Phase 1, PHASE2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	1 April 2025
Primary completion	31 March 2027
Estimated completion	31 July 2027
Sites	1 location across United States

Drugs / interventions tested

• BMX-001 — full drug profile →
• Paclitaxel (Taxol) — full drug profile →

Conditions studied

• Ovarian Neoplasms — all drugs for Ovarian Neoplasms →
• Endometrial Cancer, Endometrial Neoplasm — all drugs for Endometrial Cancer, Endometrial Neoplasm →

Sponsor

BioMimetix JV, LLC — full company profile →

Who can join

18 and older, female only, with Ovarian Neoplasms or Endometrial Cancer, Endometrial Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This research project addresses the urgent need for novel therapeutic strategies to overcome chemotherapy resistance and mitigate chemotherapy-induced peripheral neuropathy (CIPN) in patients with recurrent ovarian and endometrial cancers, which are among the most lethal gynecologic malignancies worldwide. The study focuses on BMX-001, a redox-active manganese metalloporphyrin compound that uniquely combines the ability to enhance anti-tumor efficacy and protect normal tissues from the toxic effects of chemotherapy, specifically paclitaxel (PTX). PTX, despite being a cornerstone of treatment, is associated with significant dose-limiting neurotoxicity, which severely impacts patients quality of life and limits the use of subsequent therapies. BMX-001 has demonstrated potential in preclinical models to not only augment the anti-tumor effects of PTX but also reduce PTX-induced neuropathy.

The research will be conducted through a single-site, Phase 1/2 clinical trial led by the Duke Cancer Institute. The trial aims to determine the recommended Phase 2 dose of BMX-001 when combined with weekly PTX and to evaluate the clinical activity of this combination therapy. Specifically, the trial will assess the safety, tolerability, and potential to double the dose of BMX-001, which is hypothesized to further enhance the efficacy of PTX without increasing toxicity. The study\'s specific aims include establishing the recommended dose for expansion, assessing objective response rates (ORR), and quantifying the reduction in PTX-induced neurotoxicity using validated questionnaires and monofilament testing. The project also incorporates the analysis of circulating tumor DNA (ctDNA) as a biomarker for treatment response, adding a layer of precision to the evaluation of the therapy response impact on tumor burden.

The outcomes of this research have the potential to significantly improve treatment protocols for patients with chemo-resistant gynecologic cancers by offering a therapy that enhances tumor control while protecting against debilitating side effects. Successful completion of this trial will lay the groundwork for larger, definitive trials and may extend the benefits of BMX-001 to other solid tumors, ultimately contributing to better survival outcomes and quality of life for a broader patient population.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. NRF2 immunobiology in cancer: implications for immunotherapy and therapeutic targeting.
   Panda H, Rowland NG, Krall CM, Bowman BM, et al · · 2025 · cited 6× · PMID 40946102 · DOI 10.1038/s41388-025-03560-4