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Clinical Trials in Germany / NCT06832722
Recruiting Phase 1/2

A Phase 1b/2a Trial to Evaluate Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care.

NCT06832722 · tracked via the Priya Life Science Germany tracker
Sponsor
4TEEN4 Pharmaceuticals GmbH
Phase
Phase 1/2
Started
2025-07-13
Last updated
2026-09-14

Condition(s) studied

Shock, Cardiogenic

Investigational drug(s) / intervention(s)

AK1967 (Invobenitug also known as Procizumab)Placebo

AK1967 (Invobenitug also known as Procizumab): DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)

Placebo: Application of placebo

Study summary

The objective of this Phase 1b/2a trial is to evaluate the safety, tolerability, and exploratory efficacy of invobenitug (also known as procizumab), a monoclonal antibody under development for the treatment of cardiogenic shock (CS). CS is a life-threatening hypoperfusion of vital organs that frequently results in death. In addition to safety and tolerability, pharmacokinetics and pharmacodynamics of invobenitug are evaluated to define the optimum phase 2 dose (P2D) of invobenitug.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Signed informed consent. 2. Diagnosis of CS based on the following entry criteria: 1. Need for ongoing vasopressors and/or inotropes to maintain a MAP ≥ 65 mmHg or SBP ≥ 90 mmHg 2. Lactate ≥ 2.0 mmol/L 3. High DPP3 concentration ≥ 30 ng/mL 3. Etiology of CS must be one of the following: ACS, septic (according to SEPSIS 3 criteria) or adHF origin Exclusion Criteria: 4. Patients who will be receiving vasopressors and/or inotropes for more than 16 hours prior to receiving the IMP. 5. Patients being longer than 24 hours in the ICU at the time of randomization. 6. Patients below the age of 18 or above 80 years. 7. Patients receiving Ang II and/or levosimendan 8. Patients with known allergies or hypersensitivity to the IMP or its excipients or any related medication. 9. Stroke or transient ischemic attack within the last 3 months. 10. SCAI Shock Stage E. 11. Reduced life expectancy of less than 6 months due to comorbidities (prior to shock onset). 12. Very severe frailty, or moribund condition or presence of clinical circumstances indicating imminent death. 13. Only for Part 1: Patients on cannula-based MCS (including VV and VA-ECMO, impella or left ventricular assist device of any type (excluding IABP)) or on renal replacement therapy. Patients who are treated by impella and/or ECMO but have no evidence of hemolysis during screening can be enrolled in the trial. 14. Patients exceeding a maximum body weight of 120 kg (EU, Armenia, Serbia) and 150 kg (US). 15. CPR lasting more than 15 minutes and/or the patient is not conscious at randomization. 16. Primary hypertrophic or restrictive cardiomyopathy or congenital heart disease or systemic illness known to be associated with infiltrative heart disease. 17. Pericardial constriction. 18. Sustained SBP \> 120 mmHg during the hour prior to randomization. 19. Known severe chronic liver disease (Model for End-Stage Liver Disease (MELD) Score \>30), known severe chronic pulmonary disease (including COPD classification GOLD4 and/or chronic oxygen therapy and/or restrictive chronic pulmonary failure and/or severe interstitial lung disease), known severe thyroid disease, known CKD with eGFR \<20 ml/min/1.73 m2 or chronic dialysis. 20. Patients with untreated sepsis. 21. Patients with valvular heart diseases as the primary cause of cardiogenic shock. 22. Other known causes of shock, namely 1. Hypovolemia 2. Hemorrhage 3. Anaphylaxis 4. Intoxication (e.g., drug-induced shock) 5. Dynamic left ventricular outflow tract obstruction 6. isolated right heart failure, including cardiac tamponade and/or pulmonary embolism 7. Known mechanical complications due to myocardial infarction, including papillary muscle rupture, ventricular septal rupture, free wall rupture 8. Inappropriate pacing or shock resulting from ICD malfunction 23. Patients who have severe immune suppression: recent (\<3 months) chemotherapy and/or severe neutropenia (neutrophile count \<500 cells/mm3) and/or chronic high glucocorticoid dose (≥0.5 mg/kg per day of prednisone equivalent) and/or recent (\<3 months) organ transplantation. 24. Patients who have undergone any form of surgery in the last 7 days, except 1) minor surgeries such as cosmetic surgeries, skin surgery, dental surgery and impella implantation 2) surgery for peritonitis with adequate source control, which are allowed. 25. Women who are pregnant or breastfeeding. 26. Patients who are currently enrolled in another clinical trial, or who have participated in such trials within one month prior to randomization. 27. Any reason that the investigator anticipates that the patient will be unable to complete the protocol or its required procedures (US only).

Primary outcome measure(s)

Trial sites (37)

FacilityCityRegionStatus
Yerevan medical scientific center Yerevan Armenia Not Yet Recruiting
Erebouni Mwdical Center Yerevan Armenia Not Yet Recruiting
Heart Center Aalst, AZORG Aalst Belgium Recruiting
University Hospital Saint Pierre Brussels Belgium Recruiting
Ghent University Hospital Ghent Belgium Not Yet Recruiting
University Hospital and Medical Faculty of Pilsen Pilsen Czechia Recruiting
Charles University Motol University Hospital Prague Czechia Recruiting
General University Hospital in Prague - FVN Prague Czechia Recruiting
Institute of Clinical and Experimental Medicine - IKEM Prague Czechia Recruiting
University Hospital Avicenne AP-HP Bobigny France Recruiting
Département d'anesthésie-réanimation Dijon France Not Yet Recruiting
University Hospital Lille - Institut Cœur Poumon Lille France Recruiting
University Hospital - Dupuytren Limoges Limoges France Recruiting
Regional University Hospital Nancy - Hopitaux de Brabois Nancy France Recruiting
Hôpital Pitié Salpêtrière Paris France Not Yet Recruiting
Lariboisière Hospital AP-HP Paris France Recruiting
Deutsches Herzzentrum der Charite (DHZC) Berlin Germany Not Yet Recruiting
Universitätsklinikum Freiburg Freiburg im Breisgau Germany Not Yet Recruiting
University Medical Center Hamburg-Eppendorf Hamburg Germany Not Yet Recruiting
Herzzentrum Leipzig GmbH Leipzig Germany Not Yet Recruiting
Universitätsmedizin Mannheim Mannheim Germany Not Yet Recruiting
Radboud University Medical Center Nijmegen Netherlands Recruiting
Uniersytecki Szpital Kliniczny w Białystoku Bialystok Poland Recruiting
Górnośląskie Centrum Medyczne w Katowicach / Śląski Uniwersytet Medyczny w Katowicach Katowice Poland Recruiting
Clinical University Hospital Poznań Poznan Poland Recruiting
J. Mikulicz Radecki Clinical University Hospital Wrocław Wroclaw Poland Recruiting
Clinical Hospital Center Bezanijska Kosa Belgrade Serbia Not Yet Recruiting
Institute for Cardiovascular Diseases of Vojvodina Kamenitz Serbia Not Yet Recruiting
Clinical Center Niš Niš Serbia Not Yet Recruiting
Fundación Pública Galega de Investigación Biomédica INIBIC A Coruña Spain Not Yet Recruiting
Fundació Hospital Universitari Vall d'Hebron Barcelona Spain Not Yet Recruiting
Fundació Hospital Universitari Vall d'Hebron Barcelona Spain Not Yet Recruiting
Hospital Clinic de Barcelona Barcelona Spain Not Yet Recruiting
Hospital de la Santa Creu i Sant Pau Barcelona Spain Not Yet Recruiting
L'Hospitalet de Llobregat Barcelona Spain Not Yet Recruiting
Fundación para la Investigación Biomédica del Hospital Universitario La Paz Madrid Spain Not Yet Recruiting
Hospital Universitario 12 De Octubre Madrid Spain Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06832722 on ClinicalTrials.gov ↗ ← All trials in Germany