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

NCT04876755 | Unknown Phase 2 FDA Drug

• 1 other identifier: MBI-17-01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer Recurrent; Biochemical Recurrent Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Reduction in Serum PSA

  To determine whether the proportion of patients who achieve a ≥ 50% decline in serum PSA after 16 weeks of protocol therapy.

  baseline to week 20

Secondary Outcomes (2)

• PSA progression

  baseline to week 20

• Percent Change in PSA

  baseline to week 20

Study Arms (6)

Cohort 1

EXPERIMENTAL

Cohort 1 patients will administered 600 mg/day of MBM-02 for 20 weeks.

Drug: MBM-02

Cohort 2

EXPERIMENTAL

Cohort 2 patients will administered 1000 mg/day of MBM-02 for 20 weeks.

Drug: MBM-02

Cohort 3

EXPERIMENTAL

Cohort 3 patients will administered 1200 mg/day of MBM-02 for 20 weeks.

Drug: MBM-02

Cohort 4

EXPERIMENTAL

Cohort 4 patients will administered 600 mg/day of MBM-02 for 20 weeks.

Drug: MBM-02

Cohort5

EXPERIMENTAL

Cohort 5 patients will administered 600 mg/day of MBM-02 for 20 weeks.

Drug: MBM-02

Cohort 6

EXPERIMENTAL

Cohort 6 patients will administered 600 mg/day of MBM-02 for 20 weeks.

Drug: MBM-02

Interventions

MBM-02 DRUG

MBM-02 is an HIF-1 and HIF-2 inhibitor.

Also known as: Tempol; 4-hydroxy-tempo; 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 6; Cohort5

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male 18 years or older;
• Histologically or cytologically confirmed diagnosis of prostate cancer;
• Patient must have had previous treatment with definitive surgery or radiation therapy, cryoablation, or brachytherapy;
• Patient may have prior salvage therapy (surgery, radiation or other local ablative procedures) within 6 months prior to randomization if the intent was for cure. Prophylactic radiotherapy to prevent gynecomastia within 4 weeks prior to randomization is allowed
• Patient must have evidence of biochemical failure after primary therapy and subsequent progression. Biochemical failure is declared when the PSA reaches a threshold value after primary treatment and it differs for radical prostatectomy or radiation therapy:
• For radical prostatectomy the threshold for this study is PSA ≥ 0.8ng/mL
• For radiation therapy the threshold is a PSA rise of 2 ng/mL above the nadir PSA achieved post radiation with or without hormone therapy (2006 RTOG-ASTRO Consensus definition).
• PSA progression requires a PSA rise above the threshold measured at any time point since the threshold was reached;
• PSA doubling time ≤ 12 months. PSA calculation requires two consecutive PSA rises (PSA2 and PSA3) above the threshold PSA (total 3 PSA values); PSA2 and PSA3 must be obtained within 12 months of study entry. All baseline PSAs should be obtained at the same reference lab.
• ECOG performance status less than or equal to 2;
• Ability to swallow the study drugs;
• If a male with a female partner of child bearing potential, adequate methods of contraception must be employed;
• If male, no sperm donation for 90 days until after the conclusion of the study;
• Be properly informed of the nature and risks of the clinical investigation, comply with all clinical investigation-related procedures, and sign an Informed Consent Form prior to entering the clinical investigation;
• Be able to participate for the full term of the clinical investigation;

You may not qualify if:

• Evidence of metastatic disease on imaging studies (CT and/or bone scan);
• Diagnosis of diabetes mellitus defined as:
• Fasting blood glucose \> 126 mg/dl or,
• Random blood glucose \> 200 mg/dl
• Hemoglobin A1C \> 6.5%
• Patients with QTc \>480 msec
• Need for treatment with any conventional modality for prostate cancer (surgery, radiation therapy, and hormonal therapy);
• Treatment within the last 30 days with any investigational drug;
• Radiation therapy within prior 6 months (prophylactic radiotherapy to prevent gynecomastia within 4 weeks prior to randomization is allowed);
• Patient with previous or concurrent malignancy. Exceptions are made for patients who meet any of the following conditions: Basal cell or squamous cell carcinoma of the skin or prior malignancy that has been adequately treated and patient has been continuously disease free for ≥ 2 years;
• Evidence of a significant medical illness, or a psychiatric illness/social situation that would, in the investigator's judgment, make the patient inappropriate for this study;
• Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption of the study drug;
• Have had a recent, serious, non-malignant medical complication that, in the opinion of the investigator, makes the individual unsuitable for study participation;
• Have used an investigational drug within 28 days of the initiation of study treatment;
• Have a history of a positive blood test for HIV;

Sponsors & Collaborators

• Matrix Biomed, Inc.: lead
• Prostate Oncology Specialists: collaborator

Study Sites (1)

Prostate Oncology Specialists

Marina del Rey, California, 90292, United States

Location

Related Publications (1)

• Thomas R, Sharifi N. SOD mimetics: a novel class of androgen receptor inhibitors that suppresses castration-resistant growth of prostate cancer. Mol Cancer Ther. 2012 Jan;11(1):87-97. doi: 10.1158/1535-7163.MCT-11-0540. Epub 2011 Dec 15.

  PMID: 22172488 BACKGROUND

Related Links

• Related Info

MeSH Terms

Interventions

tempol; TEMPOL-H

Central Study Contacts

Benji Crane

CONTACT

6264376506; bjcrane@matrixbiomed.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: For the dose comparison phase, five entry dosing regimens will be explored and represented by Cohort 1 through Cohort 5. The first 3 patients (Cohort 1) will begin with a total daily dose (TDD) of 600 mg of MBM-02. The study will employ a 3+3 design with Cohort 5 dose at 1600 mg/day. Cohort 6 will enroll up to 40 patients at 1600 mg/day of MBM02.

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 6, 2021
• Study Start: May 30, 2021
• Primary Completion: September 1, 2022
• Study Completion: February 1, 2023
• Last Updated: May 6, 2021

Record last verified: 2021-05

Locations

US (1)