MDPK67b treatment for prostate cancer patients

Open-label Phase Ib Study of Preoperative Treatment With the KLK Inhibitor MDPK67b in Patients With Untreated Prostate Cancer

This study is testing a new treatment called MDPK67b to see if it is safe and helps men with prostate cancer feel better and manage their disease.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Med Discovery SA (industry)
• Locations: 1 site (Zürich)
• Trial ID: NCT05580107 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and tolerability of MDPK67b in patients diagnosed with prostate cancer, specifically those with a Gleason score of 7 or higher. Participants will receive the treatment and undergo assessments to observe histo-pathological and molecular changes in their prostate tumor tissue samples. The study aims to gather important data on how the drug affects prostate cancer progression and patient health outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are men aged 18 years or older with untreated suspected prostate cancer or those under active surveillance showing signs of progression.

Not a fit: Patients with uncontrolled diseases or those requiring significant changes in their medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with prostate cancer, potentially improving their prognosis.

How similar studies have performed: While this approach is novel, similar studies targeting prostate cancer treatments have shown promising results in the past.

Eligibility criteria

Subject screening criteria

1. Patients aged 18 years or older.
2. Patients who have untreated suspected PCa or PCa under active surveillance (AS) with progression/upgrading.
3. Patients who signed a written screening phase ICF.

Subject non-screening criteria

1. Patients who have an uncontrolled disease that would unduly increase the risk of toxicity or limit compliance with study requirements in the opinion of the Investigator; including but not limited to: ongoing or active symptomatic infection, uncontrolled diabetes mellitus, diseases of the coagulation system, unstable or uncompensated cardiac, hepatic, renal, respiratory, or psychiatric disease.
2. Patients who required a significant change in their concomitant medications during the week prior to screening visit, or who will likely need to have a change in their concomitant medications during the study. This includes any medication other than those required for PCa diagnosis or for RPE.
3. Patients who have received prior radiotherapy to the prostate.
4. Patients who have had prior exposure to MDPK67b.
5. Patients who have participated in another clinical trial within 3 months prior to screening visit, except if in the opinion of the investigator the type of trial does not interfere in any way with the present trial (eg. non-interventional observational trial). In case of doubt, the sponsor's prior approval must be obtained and the decision to include such a patient will be documented in detail.

Non-screening criteria are exclusion criteria for the screening phase.

For the patients not participating in the screening phase (ie patients with previously established PCa diagnosis), all the criteria above shall be checked prior to enrolment in the treatment phase. However, these patients do not have to sign a screening ICF (screening criterion n°3 is not applicable), and for non-screening criterion n°5, the 3-month wash-out period is prior to the inclusion visit in the treatment phase.

Subject inclusion criteria

1. Patients who still meet all the eligibility criteria checked at screening visit.
2. Patients who have untreated PCa with a Gleason score of 7 (preferably) or higher, with local disease or with metastatic disease (if metastatic, no visceral metastases, no more than five bone or lymph node metastases), and are scheduled to undergo RPE about 3 weeks later.
3. Patients with an expected minimal survival time of 12 months.
4. Patients who have an acceptable organ and marrow function as assessed at the inclusion visit and defined as follows:

   1. Absolute neutrophil count ≥ 1.5 × 109/L.
   2. Platelets ≥ 100 × 109/L.
   3. Hemoglobin ≥ 9 g/dL.
   4. Total bilirubin ≤ 1.5 × ULN, unless the patient has known Gilbert's syndrome.
   5. Aspartate amino transferase (AST) and alanine amino transferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN in presence of liver metastasis.
   6. Serum creatinine ≤ 2.0 × ULN, or GFR ≥ 30 mL/min by Cockcroft-Gault.
   7. INR \<1.5, aPTT \< 60 s
5. Patients with an ECOG performance status ≤ 1.
6. Patients who agree to refrain to donate sperm for the duration of the study.
7. Patients who signed a written treatment phase ICF.

Where this trial is running

Zürich

• Klinik für Urologie, UniversitätSpital Zürich (USZ) — Zürich, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Daniel Eberli, Prof. — Klinik für Urologie, UniversitätSpital Zürich (USZ)
• Study coordinator: Christoph Kündig

Conditions: Prostate Cancer, prostate cancer, radical prostatectomy, Gleason score 7 or higher