Clinical trial NCT05580107: MDPK67b in Patients With Prostate Cancer
Official title: Open-label Phase Ib Study of Preoperative Treatment With the KLK Inhibitor MDPK67b in Patients With Untreated Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: prostate cancer
radical prostatectomy
Gleason score 7 or higher
Lead sponsor: Med Discovery SA
Sponsor class: INDUSTRY
Collaborators: name: Camara and Partners Sàrl
name: Soladis
First posted: 2022-10-14
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Dose finding (24 and 48 mg) based on dose limiting toxicity (DLT)
Primary purpose: TREATMENT

Brief summary: Administration of MDPK67b to assess its Tolerability and Safety profile in prostate cancer patients, and to assess histo-pathological and molecular changes in prostate tumor tissue samples.


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.

Primary outcomes:
measure: Tolerability and Safety
timeFrame: Day 1
measure: Tolerability and Safety
timeFrame: Day 8
measure: Tolerability and Safety
timeFrame: Day 15
measure: Tolerability and Safety
timeFrame: Day 20-25
measure: Tolerability and Safety
timeFrame: Day 1
measure: Tolerability and Safety
timeFrame: Day 8
measure: Tolerability and Safety
timeFrame: Day 15
measure: Tolerability and Safety
timeFrame: Day 20-25
measure: Tolerability and Safety
timeFrame: Day 1
measure: Tolerability and Safety
timeFrame: Day 8
measure: Tolerability and Safety
timeFrame: Day 15
measure: Tolerability and Safety
timeFrame: Day 20-25
measure: Tolerability and Safety
timeFrame: Day 1
measure: Tolerability and Safety
timeFrame: Day 8
measure: Tolerability and Safety
timeFrame: Day 15
measure: Tolerability and Safety
timeFrame: Day 20-25
measure: Tolerability and Safety
timeFrame: Day 1
measure: Tolerability and Safety
timeFrame: Day 8
measure: Tolerability and Safety
timeFrame: Day 15
measure: Tolerability and Safety
timeFrame: Day 20-25
measure: Tolerability and Safety
timeFrame: Day 1
measure: Tolerability and Safety
timeFrame: Day 8
measure: Tolerability and Safety
timeFrame: Day 15
measure: Tolerability and Safety
timeFrame: Day 20-25
measure: Tolerability and Safety
timeFrame: Day 8
measure: Tolerability and Safety
timeFrame: Day 15
measure: Tolerability and Safety
timeFrame: Day 20-25
measure: Tolerability and Safety
timeFrame: Day 8
measure: Tolerability and Safety
timeFrame: Day 15
measure: Tolerability and Safety
timeFrame: Day 20-25
measure: Tolerability and Safety
timeFrame: Day 8
measure: Tolerability and Safety
timeFrame: Day 15
measure: Tolerability and Safety
timeFrame: Day 20-25
measure: Tolerability and Safety
timeFrame: Day 1
measure: Tolerability and Safety
timeFrame: Day 8
measure: Tolerability and Safety
timeFrame: Day 15
measure: Tolerability and Safety
timeFrame: Day 20-25
measure: Tolerability and Safety
timeFrame: Day 1
measure: Tolerability and Safety
timeFrame: Day 8
measure: Tolerability and Safety
timeFrame: Day 15
measure: Tolerability and Safety
timeFrame: Day 20-25
measure: Tolerability and Safety
timeFrame: Day 1
measure: Tolerability and Safety
timeFrame: Day 8
measure: Tolerability and Safety
timeFrame: Day 15
Secondary outcomes:
measure: Histo-pathological and molecular changes in prostate tumor tissue samples
timeFrame: Screening (Diagnostic biopsy)
measure: Histo-pathological and molecular changes in prostate tumor tissue samples
timeFrame: Day 16/17 (Radical prostatectomy sample)
measure: Histo-pathological and molecular changes in prostate tumor tissue samples
timeFrame: Screening (Diagnostic biopsy)
measure: Histo-pathological and molecular changes in prostate tumor tissue samples
timeFrame: Day 16/17 (Radical prostatectomy sample)
measure: Histo-pathological and molecular changes in prostate tumor tissue samples
timeFrame: Screening (Diagnostic biopsy)
measure: Histo-pathological and molecular changes in prostate tumor tissue samples
timeFrame: Day 16/17 (Radical prostatectomy sample)
measure: Histo-pathological and molecular changes in prostate tumor tissue samples
timeFrame: Screening (Diagnostic biopsy)
measure: Histo-pathological and molecular changes in prostate tumor tissue samples
timeFrame: Day 16/17 (Radical prostatectomy sample)
measure: Histo-pathological and molecular changes in prostate tumor tissue samples
timeFrame: Screening (Diagnostic biopsy)
measure: Histo-pathological and molecular changes in prostate tumor tissue samples
timeFrame: Day 16/17 (Radical prostatectomy sample)
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Klinik für Urologie, UniversitätSpital Zürich (USZ)
Study officials:
affiliation: Klinik für Urologie, UniversitätSpital Zürich (USZ)
name: Daniel Eberli, Prof.
role: PRINCIPAL_INVESTIGATOR
References: