MDPK67b in Patients With Prostate Cancer

Med Discovery

Status and phase: Enrolling; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: MDPK67b

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05580107

MDPK67b-2002

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Dose

Experimental group

Description:

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.

Treatment:

Drug: MDPK67b