Clinical Research Directory

GEN1047 for Solid Tumors - First in Human (FIH) Trial

The purpose of this trial is to measure the following in participants with solid tumors who receive GEN1047: * The side effects seen with GEN1047 * What the body does with GEN1047 once it is administered * What GEN1047 does to the body once it is administered * How well GEN1047 works against solid tumors The estimated trial duration for an individual participant is 8 months, consisting of a 28-day screening period, an estimated 3 month treatment period (the duration of treatment may vary for each participant), and an estimated 4 month post-treatment follow-up period (the duration of follow-up may vary for each participant). All participants will receive active drug; no one will be given placebo.

Precision Medicine Applied to the Study of Endometrial Cancer: Application of NGS for Molecular Classification

In recent years, knowledge about cancer biology has expanded significantly. The study of gene expression profiles has revealed the heterogeneous nature and potential reclassification of the various tumor subtypes based on specific genetic alterations. This is of great importance since it allows a therapeutic approach more directed to the intrinsic characteristics of each tumor (precision medicine). Integrating clinicopathological information with molecular classification could provide new guidelines when approaching patients with EC, both in preoperative assessment and in adjuvant treatment and surveillance. The application of molecular classification in endometrial carcinomas shows a subgroup of patients with an excellent prognosis, corresponding to the POLEmut subgroup that could be reclassified with eventual therapeutic de-escalation. The clinical guidelines for the management of patients with endometrial cancer proposed by ESGO/ESTRO/ESP in 2020 recommend the use of this new classification, and warn that clinical management may be modified by the molecular classification in scenarios where adjuvant chemotherapy is considered (high-grade/high-risk disease).

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

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.