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Prostate CancerPhase 1NCT05580107

MDPK67b in Patients With Prostate Cancer

A Phase 1 study testing MDPK67b in people with Prostate Cancer, run by Med Discovery SA at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
MDPK67b
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSwitzerland
Study dates
9 Aug 2021to 30 Jun 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

Christoph Kündig contact

+41 21 566 14 11

christoph.kundig@med-discovery.com

Switzerland1 site, 1 recruiting

  • Klinik für Urologie, UniversitätSpital Zürich (USZ)

    Zurich, 8091

    Daniel Eberli, Prof., +41 44 255 9619, daniel.eberli@usz.ch

    Recruiting

Other trials in Switzerland

About this study

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

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.

Conditions
Prostate Cancer
Being tested
MDPK67b
Keywords
prostate cancer, radical prostatectomy, Gleason score 7 or higher
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MDPK67bDrug

    24 mg or 48 mg

Study groups in NCT05580107
Study groupRoleWhat they receive
DoseExperimentalFive patients will be included into the 24 mg dose level. In case of dose limiting toxicity (DLT) in at least one patient, 5 additional patients will be enrolled in the 24 mg dose level. If the treatment is well tolerated, i.e. no DLT is encountered, the dose of MDPK67b is escalated to 48 mg on a second cohort of 5 patients. In case of DLT in at least one patient at the 48 mg dose level, the 24 mg dose level of MDPK67b is expanded from 5 to 10 patients, or declared the maximum tolerated dose (MTD) if already expanded to 10 patients.
Receives: Drug: MDPK67b

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tolerability and Safety

    Number of subjects with changes in blood pressure

    Measured: Day 1

  2. Tolerability and Safety

    Number of subjects with changes in blood pressure

    Measured: Day 8

  3. Tolerability and Safety

    Number of subjects with changes in blood pressure

    Measured: Day 15

  4. Tolerability and Safety

    Number of subjects with changes in blood pressure

    Measured: Day 20-25

  5. Tolerability and Safety

    Body temperature

    Measured: Day 1

  6. Tolerability and Safety

    Number of subjects with changes in body temperature

    Measured: Day 8

  7. Tolerability and Safety

    Number of subjects with changes in body temperature

    Measured: Day 15

  8. Tolerability and Safety

    Number of subjects with changes in body temperature

    Measured: Day 20-25

  9. Tolerability and Safety

    Number of subjects with changes in respiration rate

    Measured: Day 1

  10. Tolerability and Safety

    Number of subjects with changes in respiration rate

    Measured: Day 8

  11. Tolerability and Safety

    Number of subjects with changes in respiration rate

    Measured: Day 15

  12. Tolerability and Safety

    Number of subjects with changes in respiration rate

    Measured: Day 20-25

  13. Tolerability and Safety

    Number of subjects with changes in weight

    Measured: Day 1

  14. Tolerability and Safety

    Number of subjects with changes in weight

    Measured: Day 8

  15. Tolerability and Safety

    Number of subjects with changes in weight

    Measured: Day 15

  16. Tolerability and Safety

    Number of subjects with changes in weight

    Measured: Day 20-25

  17. Tolerability and Safety

    Number of subjects with changes in QTc on ECG

    Measured: Day 1

  18. Tolerability and Safety

    Number of subjects with changes in QTc on ECG

    Measured: Day 8

  19. Tolerability and Safety

    Number of subjects with changes in QTc on ECG

    Measured: Day 15

  20. Tolerability and Safety

    Number of subjects with changes in QTc on ECG

    Measured: Day 20-25

  21. Tolerability and Safety

    Number of subjects with changes in heart rate on ECG

    Measured: Day 1

  22. Tolerability and Safety

    Number of subjects with changes in heart rate on ECG

    Measured: Day 8

  23. Tolerability and Safety

    Number of subjects with changes in heart rate on ECG

    Measured: Day 15

  24. Tolerability and Safety

    Number of subjects with changes in heart rate on ECG

    Measured: Day 20-25

  25. Tolerability and Safety

    Number of subjects with changes in hematology safety parameters: haemoglobin, haematocrit, RBC, MCH, MCV, WBC differential count (absolute and relative count), platelet count, INR, aPTT, Thrombin time and fibrinogen

    Measured: Day 8

  26. Tolerability and Safety

    Number of subjects with changes in hematology safety parameters: haemoglobin, haematocrit, RBC, MCH, MCV, WBC differential count (absolute and relative count), platelet count, INR, aPTT, Thrombin time and fibrinogen

    Measured: Day 15

  27. Tolerability and Safety

    Number of subjects with changes in hematology safety parameters: haemoglobin, haematocrit, RBC, MCH, MCV, WBC differential count (absolute and relative count), platelet count, INR, aPTT, Thrombin time and fibrinogen

    Measured: Day 20-25

  28. Tolerability and Safety

    Number of subjects with changes in blood chemistry safety parameters: fasting glucose, total protein, creatinine, urea, sodium, potassium, calcium, uric acid, AST, ALT, CPK, AlkP, LDH, total bilirubin, PSA

    Measured: Day 8

  29. Tolerability and Safety

    Number of subjects with changes in blood chemistry safety parameters: fasting glucose, total protein, creatinine, urea, sodium, potassium, calcium, uric acid, AST, ALT, CPK, AlkP, LDH, total bilirubin, PSA

    Measured: Day 15

  30. Tolerability and Safety

    Number of subjects with changes in blood chemistry safety parameters: fasting glucose, total protein, creatinine, urea, sodium, potassium, calcium, uric acid, AST, ALT, CPK, AlkP, LDH, total bilirubin, PSA

    Measured: Day 20-25

  31. Tolerability and Safety

    Number of subjects with changes in urine safety parameters: pH, ketones, protein, glucose, blood, leukocytes, urobilinogen, bilirubin

    Measured: Day 8

  32. Tolerability and Safety

    Number of subjects with changes in urine safety parameters: pH, ketones, protein, glucose, blood, leukocytes, urobilinogen, bilirubin

    Measured: Day 15

  33. Tolerability and Safety

    Number of subjects with changes in urine safety parameters: pH, ketones, protein, glucose, blood, leukocytes, urobilinogen, bilirubin

    Measured: Day 20-25

  34. Tolerability and Safety

    Number of subjects with changes in physical examination

    Measured: Day 1

  35. Tolerability and Safety

    Number of subjects with changes in physical examination

    Measured: Day 8

  36. Tolerability and Safety

    Number of subjects with changes in physical examination

    Measured: Day 15

  37. Tolerability and Safety

    Number of subjects with changes in physical examination

    Measured: Day 20-25

  38. Tolerability and Safety

    Adverse events

    Measured: Day 1

  39. Tolerability and Safety

    Adverse events

    Measured: Day 8

  40. Tolerability and Safety

    Adverse events

    Measured: Day 15

  41. Tolerability and Safety

    Adverse events

    Measured: Day 20-25

  42. Tolerability and Safety

    Local tolerance using the 5-point Draize scale (0: no irritation to 5: Frank vein thrombosis in addition to grade 4 signs and symptoms)

    Measured: Day 1

  43. Tolerability and Safety

    Local tolerance using the 5-point Draize scale (0: no irritation to 5: Frank vein thrombosis in addition to grade 4 signs and symptoms)

    Measured: Day 8

  44. Tolerability and Safety

    Local tolerance using the 5-point Draize scale (0: no irritation to 5: Frank vein thrombosis in addition to grade 4 signs and symptoms)

    Measured: Day 15

Secondary outcomes (10)

  1. Histo-pathological and molecular changes in prostate tumor tissue samples

    Androgen receptor expression

    Measured: Screening (Diagnostic biopsy)

  2. Histo-pathological and molecular changes in prostate tumor tissue samples

    Androgen receptor expression

    Measured: Day 16/17 (Radical prostatectomy sample)

  3. Histo-pathological and molecular changes in prostate tumor tissue samples

    Extent of proliferation using Ki67

    Measured: Screening (Diagnostic biopsy)

  4. Histo-pathological and molecular changes in prostate tumor tissue samples

    Extent of proliferation using Ki67

    Measured: Day 16/17 (Radical prostatectomy sample)

  5. Histo-pathological and molecular changes in prostate tumor tissue samples

    Extent of inflammation using leukocyte markers

    Measured: Screening (Diagnostic biopsy)

  6. Histo-pathological and molecular changes in prostate tumor tissue samples

    Extent of inflammation using leukocyte markers

    Measured: Day 16/17 (Radical prostatectomy sample)

  7. Histo-pathological and molecular changes in prostate tumor tissue samples

    Expression of KLK2, KLK4, and KLK14 using immunohistochemistry

    Measured: Screening (Diagnostic biopsy)

  8. Histo-pathological and molecular changes in prostate tumor tissue samples

    Expression of KLK2, KLK4, and KLK14 using immunohistochemistry

    Measured: Day 16/17 (Radical prostatectomy sample)

  9. Histo-pathological and molecular changes in prostate tumor tissue samples

    Treatment induced change in RNA transcriptome assessed by RNA sequencing

    Measured: Screening (Diagnostic biopsy)

  10. Histo-pathological and molecular changes in prostate tumor tissue samples

    Treatment induced change in RNA transcriptome assessed by RNA sequencing

    Measured: Day 16/17 (Radical prostatectomy sample)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2022
  2. Study start9 Aug 2021
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Dose finding (24 and 48 mg) based on dose limiting toxicity (DLT)
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05580107
Sponsor's protocol ID
MDPK67b-2002
Status last verified
Nov 2023
First submitted
7 Jul 2022
Last updated
7 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MDPK67b in people with Prostate Cancer, run by Med Discovery SA at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Christoph Kündig (+41 21 566 14 11, christoph.kundig@med-discovery.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability and Safety (time frame: Day 1). The study lists 44 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05580107.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.

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