MDPK67b in Patients With Prostate Cancer

NCT ID: NCT05580107

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-09
• Study Completion Date: 2024-06-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose

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.

Group Type: EXPERIMENTAL

MDPK67b

Intervention Type: DRUG

24 mg or 48 mg

Interventions

MDPK67b

24 mg or 48 mg

Intervention Type: DRUG

Eligibility Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Camara and Partners Sàrl

UNKNOWN

Sponsor Role: collaborator

Soladis

INDUSTRY

Sponsor Role: collaborator

Med Discovery SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Eberli, Prof.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Urologie, UniversitätSpital Zürich (USZ)

Locations

Klinik für Urologie, UniversitätSpital Zürich (USZ)

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Christoph Kündig

Role: CONTACT

christoph.kundig@med-discovery.com

+41 21 566 14 11

Facility Contacts

Daniel Eberli, Prof.

Role: primary

daniel.eberli@usz.ch

+41 44 255 9619

Other Identifiers

MDPK67b-2002

Identifier Type: -

Identifier Source: org_study_id