MDPK67b in Patients With Prostate Cancer
Phase 1
Recruiting
- Conditions
- Prostate Cancer
- Interventions
- Drug: MDPK67b
- Registration Number
- NCT05580107
- Lead Sponsor
- Med Discovery SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 15
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose MDPK67b 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.
- Primary Outcome Measures
Name Time Method Tolerability and Safety Day 15 Local tolerance using the 5-point Draize scale (0: no irritation to 5: Frank vein thrombosis in addition to grade 4 signs and symptoms)
- Secondary Outcome Measures
Name Time Method Histo-pathological and molecular changes in prostate tumor tissue samples Day 16/17 (Radical prostatectomy sample) Treatment induced change in RNA transcriptome assessed by RNA sequencing
Trial Locations
- Locations (1)
Klinik für Urologie, UniversitätSpital Zürich (USZ)
🇨🇭Zürich, Switzerland