NCT05580107

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at P25-P50 for phase_1 prostate-cancer

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

2.9 years

First QC Date

July 7, 2022

Last Update Submit

November 6, 2023

Conditions

Prostate Cancer

Keywords

prostate cancerradical prostatectomyGleason score 7 or higher

Outcome Measures

Primary Outcomes (44)

  • Tolerability and Safety

    Number of subjects with changes in blood pressure

    Day 1

  • Tolerability and Safety

    Number of subjects with changes in blood pressure

    Day 8

  • Tolerability and Safety

    Number of subjects with changes in blood pressure

    Day 15

  • Tolerability and Safety

    Number of subjects with changes in blood pressure

    Day 20-25

  • Tolerability and Safety

    Body temperature

    Day 1

  • Tolerability and Safety

    Number of subjects with changes in body temperature

    Day 8

  • Tolerability and Safety

    Number of subjects with changes in body temperature

    Day 15

  • Tolerability and Safety

    Number of subjects with changes in body temperature

    Day 20-25

  • Tolerability and Safety

    Number of subjects with changes in respiration rate

    Day 1

  • Tolerability and Safety

    Number of subjects with changes in respiration rate

    Day 8

  • Tolerability and Safety

    Number of subjects with changes in respiration rate

    Day 15

  • Tolerability and Safety

    Number of subjects with changes in respiration rate

    Day 20-25

  • Tolerability and Safety

    Number of subjects with changes in weight

    Day 1

  • Tolerability and Safety

    Number of subjects with changes in weight

    Day 8

  • Tolerability and Safety

    Number of subjects with changes in weight

    Day 15

  • Tolerability and Safety

    Number of subjects with changes in weight

    Day 20-25

  • Tolerability and Safety

    Number of subjects with changes in QTc on ECG

    Day 1

  • Tolerability and Safety

    Number of subjects with changes in QTc on ECG

    Day 8

  • Tolerability and Safety

    Number of subjects with changes in QTc on ECG

    Day 15

  • Tolerability and Safety

    Number of subjects with changes in QTc on ECG

    Day 20-25

  • Tolerability and Safety

    Number of subjects with changes in heart rate on ECG

    Day 1

  • Tolerability and Safety

    Number of subjects with changes in heart rate on ECG

    Day 8

  • Tolerability and Safety

    Number of subjects with changes in heart rate on ECG

    Day 15

  • Tolerability and Safety

    Number of subjects with changes in heart rate on ECG

    Day 20-25

  • 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

    Day 8

  • 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

    Day 15

  • 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

    Day 20-25

  • 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

    Day 8

  • 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

    Day 15

  • 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

    Day 20-25

  • Tolerability and Safety

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

    Day 8

  • Tolerability and Safety

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

    Day 15

  • Tolerability and Safety

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

    Day 20-25

  • Tolerability and Safety

    Number of subjects with changes in physical examination

    Day 1

  • Tolerability and Safety

    Number of subjects with changes in physical examination

    Day 8

  • Tolerability and Safety

    Number of subjects with changes in physical examination

    Day 15

  • Tolerability and Safety

    Number of subjects with changes in physical examination

    Day 20-25

  • Tolerability and Safety

    Adverse events

    Day 1

  • Tolerability and Safety

    Adverse events

    Day 8

  • Tolerability and Safety

    Adverse events

    Day 15

  • Tolerability and Safety

    Adverse events

    Day 20-25

  • 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)

    Day 1

  • 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)

    Day 8

  • 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)

    Day 15

Secondary Outcomes (10)

  • Histo-pathological and molecular changes in prostate tumor tissue samples

    Screening (Diagnostic biopsy)

  • Histo-pathological and molecular changes in prostate tumor tissue samples

    Day 16/17 (Radical prostatectomy sample)

  • Histo-pathological and molecular changes in prostate tumor tissue samples

    Screening (Diagnostic biopsy)

  • Histo-pathological and molecular changes in prostate tumor tissue samples

    Day 16/17 (Radical prostatectomy sample)

  • Histo-pathological and molecular changes in prostate tumor tissue samples

    Screening (Diagnostic biopsy)

  • +5 more secondary outcomes

Study Arms (1)

Dose

EXPERIMENTAL

Five 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.

Drug: MDPK67b

Interventions

MDPK67bDRUG

24 mg or 48 mg

Dose

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients who still meet all the eligibility criteria checked at screening visit.
  • 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.
  • Patients with an expected minimal survival time of 12 months.
  • Absolute neutrophil count ≥ 1.5 × 109/L.
  • Platelets ≥ 100 × 109/L.
  • Hemoglobin ≥ 9 g/dL.
  • Total bilirubin ≤ 1.5 × ULN, unless the patient has known Gilbert's syndrome.
  • Aspartate amino transferase (AST) and alanine amino transferase (ALT) ≤ 2.5 × ULN or ≤ 5 × ULN in presence of liver metastasis.
  • Serum creatinine ≤ 2.0 × ULN, or GFR ≥ 30 mL/min by Cockcroft-Gault.
  • INR \<1.5, aPTT \< 60 s
  • Patients with an ECOG performance status ≤ 1.
  • Patients who agree to refrain to donate sperm for the duration of the study.
  • Patients who signed a written treatment phase ICF.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Urologie, UniversitätSpital Zürich (USZ)

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Daniel Eberli, Prof.

    Klinik für Urologie, UniversitätSpital Zürich (USZ)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Kündig

CONTACT

+41 21 566 14 11christoph.kundig@med-discovery.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Dose finding (24 and 48 mg) based on dose limiting toxicity (DLT)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2022

First Posted

October 14, 2022

Study Start

August 9, 2021

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

November 7, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)