NCT04876755

MBM-02 (Tempol) for the Treatment of Biochemical Recurrent Prostate Cancer

An Open Label, Dose Comparison Study to Assess the Efficacy of MBM-02 (Tempol) as a Treatment for Patients Diagnosed With Prostate Cancer in Biochemical Recurrence

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: Matrix Biomed, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label trial to assess the efficacy of MBM-02 (Tempol) as a treatment for patients diagnosed with prostate cancer in biochemical recurrence.

Detailed description

Preliminary data shows MBM-02 has anti-prostate cancer activity without hormone suppression or toxicity to non-cancerous cells and organs. Solid tumors contain hypoxic regions (low oxygen) due to their high rates of cell proliferation and formation of aberrant blood vessels. Intratumoral hypoxia is associated with increased risk of invasion, metastasis, and patient mortality. Cancer cells respond to hypoxia by stabilizing hypoxia-inducible factor 1 (HIF-1) and hypoxia inducible factor 2 (HIF-2). HIF-1 and HIF-2 activate a transcription of genes encoding proteins that mediate major adaptive responses to hypoxia that are critical for cancer cell survival. Without activation of HIF-1 and HIF-2, cancer cells would not survive. MBM-02 has been shown to inhibit the genes responsible for prostate carcinogenesis, HIF-1 and HIF-2. This trial is an open label study that will employ a 3+3 escalation design up to 1600 mg/day. Patients will be exposed to study drug for 20 weeks. PSA and scans will be taken at baseline and week 20 for efficacy.

Conditions

• Prostate Cancer Recurrent
• Biochemical Recurrent Prostate Cancer

Interventions

Type	Name	Description
DRUG	MBM-02	MBM-02 is an HIF-1 and HIF-2 inhibitor.

Timeline

• Start date: 2021-05-30
• Primary completion: 2022-09-01
• Completion: 2023-02-01
• First posted: 2021-05-06
• Last updated: 2021-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study