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

May 3, 2021 updated by: Matrix Biomed, Inc.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Phase 2

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Marina Del Rey, California, United States, 90292
        • Prostate Oncology Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Male 18 years or older;
  2. Histologically or cytologically confirmed diagnosis of prostate cancer;
  3. Patient must have had previous treatment with definitive surgery or radiation therapy, cryoablation, or brachytherapy;
  4. 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

  5. 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:

    1. For radical prostatectomy the threshold for this study is PSA ≥ 0.8ng/mL
    2. 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).
  6. PSA progression requires a PSA rise above the threshold measured at any time point since the threshold was reached;
  7. 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.
  8. ECOG performance status less than or equal to 2;
  9. Ability to swallow the study drugs;
  10. If a male with a female partner of child bearing potential, adequate methods of contraception must be employed;
  11. If male, no sperm donation for 90 days until after the conclusion of the study;
  12. 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;
  13. Be able to participate for the full term of the clinical investigation;
  14. Have a Karnofsky performance status of >70;
  15. Have a life expectancy ≥ 6 months; and
  16. Have adequate baseline organ function (hematologic, liver, renal, nutritional and metabolic):

Hematology:

Absolute neutrophil count (ANC) ≥1.5 Hemoglobin ≥ 10 g/dL Platelets ≥ 100,000 per microliter of blood

Hepatic:

Total bilirubin ≤ 2 x ULN Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤2.5 x ULN

Renal:

creatinine clearance (CrCl) ≥ 60 ml/min within 2 weeks prior to registration determined by 24-hour collection or estimated by Cockcroft-Gault formula: CrCl male = [(140 - age) x (wt in kg)] [(Serum Cr mg/dl) x (72)] CrCl female = 0.85 x (CrCl male)

Exclusion Criteria:

  1. Evidence of metastatic disease on imaging studies (CT and/or bone scan);

  2. Diagnosis of diabetes mellitus defined as:

    1. Fasting blood glucose > 126 mg/dl or,
    2. Random blood glucose > 200 mg/dl
    3. Hemoglobin A1C > 6.5%
  3. Patients with QTc >480 msec
  4. Need for treatment with any conventional modality for prostate cancer (surgery, radiation therapy, and hormonal therapy);
  5. Treatment within the last 30 days with any investigational drug;
  6. Radiation therapy within prior 6 months (prophylactic radiotherapy to prevent gynecomastia within 4 weeks prior to randomization is allowed);
  7. 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;
  8. 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;
  9. Refractory nausea and vomiting, malabsorption, biliary shunt, or significant bowel resection that would preclude adequate absorption of the study drug;
  10. Have had a recent, serious, non-malignant medical complication that, in the opinion of the investigator, makes the individual unsuitable for study participation;
  11. Have used an investigational drug within 28 days of the initiation of study treatment;
  12. Have a history of a positive blood test for HIV;
  13. At the time of screening, have a significant active medical illness which, in the opinion of the investigator, would preclude completion of the study; and
  14. Body weight less than 35 kg (77 lbs.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Cohort 1 patients will administered 600 mg/day of MBM-02 for 20 weeks.
Drug: MBM-02
MBM-02 is an HIF-1 and HIF-2 inhibitor.
Other Names:
  • Tempol; 4-hydroxy-tempo; 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl
Experimental: Cohort 2
Cohort 2 patients will administered 1000 mg/day of MBM-02 for 20 weeks.
Drug: MBM-02
MBM-02 is an HIF-1 and HIF-2 inhibitor.
Other Names:
  • Tempol; 4-hydroxy-tempo; 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl
Experimental: Cohort 3
Cohort 3 patients will administered 1200 mg/day of MBM-02 for 20 weeks.
Drug: MBM-02
MBM-02 is an HIF-1 and HIF-2 inhibitor.
Other Names:
  • Tempol; 4-hydroxy-tempo; 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl
Experimental: Cohort 4
Cohort 4 patients will administered 600 mg/day of MBM-02 for 20 weeks.
Drug: MBM-02
MBM-02 is an HIF-1 and HIF-2 inhibitor.
Other Names:
  • Tempol; 4-hydroxy-tempo; 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl
Experimental: Cohort5
Cohort 5 patients will administered 600 mg/day of MBM-02 for 20 weeks.
Drug: MBM-02
MBM-02 is an HIF-1 and HIF-2 inhibitor.
Other Names:
  • Tempol; 4-hydroxy-tempo; 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl
Experimental: Cohort 6
Cohort 6 patients will administered 600 mg/day of MBM-02 for 20 weeks.
Drug: MBM-02
MBM-02 is an HIF-1 and HIF-2 inhibitor.
Other Names:
  • Tempol; 4-hydroxy-tempo; 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Serum PSA
Time Frame: baseline to week 20
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSA progression
Time Frame: baseline to week 20
To determine the median time to PSA progression from the start of protocol therapy with MBM-02 among men with biochemically recurrence prostate cancer.
baseline to week 20
Percent Change in PSA
Time Frame: baseline to week 20
To determine the mean percent change from baseline after 16 weeks of protocol therapy compared with pre-treatment in PSA doubling time. The pre-treatment PSA doubling time will be determined based upon all PSA measurements obtained within 3 months prior to Day 1 of protocol therapy, with a minimum of three PSA measurements spaced at least 14 days apart
baseline to week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Matrix Biomed, Inc.

Collaborators

Prostate Oncology Specialists

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 30, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 3, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2021

Last Update Submitted That Met QC Criteria

May 3, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBI-17-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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